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SEPTEMBER 2010 - APPROVED DRUG PRODUCTS LIST

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APPENDIX B

PRODUCT NAME SORTED BY APPLICANT


** 3 **

3M * 3M CO PERIDEX, CHLORHEXIDINE GLUCONATE * 3M HEALTH CARE INC AVAGARD, ALCOHOL (OTC)


DURAPREP, IODINE POVACRYLEX (OTC)
* 3M PHARMACEUTICALS INC PROVENTIL-HFA, ALBUTEROL SULFATE AAIPHARMA LLC * AAIPHARMA LLC AZASAN, AZATHIOPRINE ABBOTT * ABBOTT LABORATORIES ADVICOR, LOVASTATIN AKINETON, BIPERIDEN HYDROCHLORIDE AZMACORT, TRIAMCINOLONE ACETONIDE BIAXIN XL, CLARITHROMYCIN BIAXIN, CLARITHROMYCIN CYCLOSPORINE, CYCLOSPORINE DEPAKOTE ER, DIVALPROEX SODIUM DEPAKOTE, DIVALPROEX SODIUM GENGRAF, CYCLOSPORINE KALETRA, LOPINAVIR NIASPAN, NIACIN NIMBEX PRESERVATIVE FREE, CISATRACURIUM BESYLATE NIMBEX, CISATRACURIUM BESYLATE NORVIR, RITONAVIR OMNICEF, CEFDINIR SIMCOR, NIACIN SYNTHROID, LEVOTHYROXINE SODIUM TEVETEN HCT, EPROSARTAN MESYLATE TEVETEN, EPROSARTAN MESYLATE ULTANE, SEVOFLURANE
ZEMPLAR, PARICALCITOL
* ABBOTT LABORATORIES HOSP PRODUCTS DIV CALCIJEX, CALCITRIOL * ABBOTT LABORATORIES PHARMACEUTICAL PRODUCTS DIV BIAXIN, CLARITHROMYCIN DEPACON, VALPROATE SODIUM DEPAKENE, VALPROIC ACID
DEPAKOTE, DIVALPROEX SODIUM
E.E.S. 200, ERYTHROMYCIN ETHYLSUCCINATE E.E.S. 400, ERYTHROMYCIN ETHYLSUCCINATE
E.E.S., ERYTHROMYCIN ETHYLSUCCINATE
ENDURON, METHYCLOTHIAZIDE
ERYPED, ERYTHROMYCIN ETHYLSUCCINATE
ERY-TAB, ERYTHROMYCIN
ERYTHROCIN STEARATE, ERYTHROMYCIN STEARATE
ERYTHROMYCIN, ERYTHROMYCIN
HYTRIN, TERAZOSIN HYDROCHLORIDE
K-TAB, POTASSIUM CHLORIDE
MAVIK, TRANDOLAPRIL
MERIDIA, SIBUTRAMINE HYDROCHLORIDE
NORVIR, RITONAVIR
ORETIC, HYDROCHLOROTHIAZIDE
PCE, ERYTHROMYCIN
POTASSIUM CHLORIDE, POTASSIUM CHLORIDE
TARKA, TRANDOLAPRIL
TRICOR, FENOFIBRATE
TRIDIONE, TRIMETHADIONE
VICODIN ES, ACETAMINOPHEN
VICODIN HP, ACETAMINOPHEN
VICODIN, ACETAMINOPHEN
VICOPROFEN, HYDROCODONE BITARTRATE

SEPTEMBER 2010 - APPROVED DRUG PRODUCTS LIST

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APPENDIX B

PRODUCT NAME SORTED BY APPLICANT


** A **

* ABBOTT LABORATORIES PHARMACEUTICAL PRODUCTS DIV ZEMPLAR, PARICALCITOL ABBOTT LABS * ABBOTT ENDOCRINE INC SUB ABBOTT LABORATORIES LUPRON DEPOT, LEUPROLIDE ACETATE LUPRON DEPOT-3, LEUPROLIDE ACETATE LUPRON DEPOT-4, LEUPROLIDE ACETATE LUPRON DEPOT-PED, LEUPROLIDE ACETATE
LUPRON, LEUPROLIDE ACETATE
* ABBOTT LABORATORIES RITONAVIR, RITONAVIR
TRILIPIX, CHOLINE FENOFIBRATE
ABBOTT PRODS * ABBOTT PRODUCTS INC CREON, LIPASE ABRAXIS BIOSCIENCE * ABRAXIS BIOSCIENCE LLC ABRAXANE, PACLITAXEL ABRAXIS PHARM * ABRAXIS PHARMACEUTICAL PRODUCTS CLINDAMYCIN PHOSPHATE IN DEXTROSE 5%, CLINDAMYCIN PHOSPHATE LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE, LIDOCAINE HYDROCHLORIDE
MAGNESIUM SULFATE, MAGNESIUM SULFATE
ACADEMIC PHARMS * ACADEMIC PHARMACEUTICALS INC SOTALOL HYDROCHLORIDE, SOTALOL HYDROCHLORIDE ACCORD HLTH * ACCORD HEALTH CARE INC METHYLDOPA, METHYLDOPA ACCORD HLTHCARE * ACCORD HEALTHCARE INC GLIMEPIRIDE, GLIMEPIRIDE IRINOTECAN HYDROCHLORIDE, IRINOTECAN HYDROCHLORIDE MITOMYCIN, MITOMYCIN MYCOPHENOLATE MOFETIL, MYCOPHENOLATE MOFETIL SIMVASTATIN, SIMVASTATIN
TOPIRAMATE, TOPIRAMATE
ACCORD HLTHCARE INC * ACCORD HEALTHCARE INC USA BICALUTAMIDE, BICALUTAMIDE ETOPOSIDE, ETOPOSIDE FINASTERIDE, FINASTERIDE MYCOPHENOLATE MOFETIL, MYCOPHENOLATE MOFETIL
PACLITAXEL, PACLITAXEL
ACIC FINE CHEMS * ACIC FINE CHEMICALS INC AMPICILLIN SODIUM, AMPICILLIN SODIUM ACORDA * ACORDA THERAPEUTICS INC AMPYRA, DALFAMPRIDINE
ZANAFLEX, TIZANIDINE HYDROCHLORIDE
ACS DOBFAR * ACS DOBFAR SPA AMPICILLIN AND SULBACTAM, AMPICILLIN SODIUM CEFAZOLIN SODIUM, CEFAZOLIN SODIUM CEFEPIME HYDROCHLORIDE, CEFEPIME HYDROCHLORIDE CEFOXITIN, CEFOXITIN SODIUM CEFTAZIDIME, CEFTAZIDIME CEFTRIAXONE, CEFTRIAXONE SODIUM
KEFZOL, CEFAZOLIN SODIUM

SEPTEMBER 2010 - APPROVED DRUG PRODUCTS LIST

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APPENDIX B

PRODUCT NAME SORTED BY APPLICANT


** A **

ACS DOBFAR INFO SA * ACS DOBFAR INFO SA CIPROFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER, CIPROFLOXACIN FLUCANAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, FLUCONAZOLE ACTAVIS * ACTAVIS SOUTHATLANTIC LLC BUPROPION HYDROCHLORIDE, FENTANYL-100, FENTANYL FENTANYL-25, FENTANYL FENTANYL-50, FENTANYL FENTANYL-75, FENTANYL
NIFEDIPINE, NIFEDIPINE

BUPROPION HYDROCHLORIDE

ACTAVIS ELIZABETH * ACTAVIS ELIZABETH LLC ACYCLOVIR, ACYCLOVIR ALPRAZOLAM, ALPRAZOLAM BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE, BISOPROLOL FUMARATE BUTALBITAL, ASPIRIN AND CAFFEINE, ASPIRIN CARBIDOPA AND LEVODOPA, CARBIDOPA CARVEDILOL, CARVEDILOL CETIRIZINE HYDROCHLORIDE ALLERGY, CETIRIZINE HYDROCHLORIDE (OTC) CLONAZEPAM, CLONAZEPAM CLONIDINE HYDROCHLORIDE, CLONIDINE HYDROCHLORIDE DIAZEPAM, DIAZEPAM DICLOFENAC SODIUM, DICLOFENAC SODIUM DILTIAZEM HYDROCHLORIDE, DILTIAZEM HYDROCHLORIDE DOXAZOSIN MESYLATE, DOXAZOSIN MESYLATE ETODOLAC, ETODOLAC FAMOTIDINE, FAMOTIDINE GABAPENTIN, GABAPENTIN GALANTAMINE HYDROBROMIDE, GALANTAMINE HYDROBROMIDE GLYBURIDE AND METFORMIN HYDROCHLORIDE, GLYBURIDE HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE INDAPAMIDE, INDAPAMIDE ISOSORBIDE MONONITRATE, ISOSORBIDE MONONITRATE KADIAN, MORPHINE SULFATE LISINOPRIL AND HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE LISINOPRIL, LISINOPRIL LORAZEPAM, LORAZEPAM LOVASTATIN, LOVASTATIN METFORMIN HYDROCHLORIDE, METFORMIN HYDROCHLORIDE METHYLPHENIDATE HYDROCHLORIDE, METHYLPHENIDATE HYDROCHLORIDE METOCLOPRAMIDE HYDROCHLORIDE, METOCLOPRAMIDE HYDROCHLORIDE MIRTAZAPINE, MIRTAZAPINE NABUMETONE, NABUMETONE NAPROXEN, NAPROXEN NIFEDIPINE, NIFEDIPINE OXAPROZIN, OXAPROZIN OXAZEPAM, OXAZEPAM OXYCODONE HYDROCHLORIDE AND IBUPROFEN, IBUPROFEN PHENTERMINE HYDROCHLORIDE, PHENTERMINE HYDROCHLORIDE PROPRANOLOL HYDROCHLORIDE, PROPRANOLOL HYDROCHLORIDE PROPYLTHIOURACIL, PROPYLTHIOURACIL RAMIPRIL, RAMIPRIL SPIRONOLACTONE, SPIRONOLACTONE TEMAZEPAM, TEMAZEPAM TICLOPIDINE HYDROCHLORIDE, TICLOPIDINE HYDROCHLORIDE TIZANIDINE HYDROCHLORIDE, TIZANIDINE HYDROCHLORIDE TOLMETIN SODIUM, TOLMETIN SODIUM TRAMADOL HYDROCHLORIDE, TRAMADOL HYDROCHLORIDE
VERAPAMIL HYDROCHLORIDE, VERAPAMIL HYDROCHLORIDE

SEPTEMBER 2010 - APPROVED DRUG PRODUCTS LIST

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APPENDIX B

PRODUCT NAME SORTED BY APPLICANT


** A **

ACTAVIS MID ATLANTIC * ACTAVIS MID ATLANTIC LLC ACETAMINOPHEN AND CODEINE PHOSPHATE, ACETAMINOPHEN ACETAMINOPHEN, ACETAMINOPHEN (OTC) ACETASOL HC, ACETIC ACID, GLACIAL ACETASOL, ACETIC ACID, GLACIAL ACYCLOVIR, ACYCLOVIR ALBUTEROL SULFATE, ALBUTEROL SULFATE BETAMETHASONE DIPROPIONATE, BETAMETHASONE DIPROPIONATE BETAMETHASONE VALERATE, BETAMETHASONE VALERATE CAPITAL AND CODEINE, ACETAMINOPHEN CETIRIZINE HYDROCHLORIDE, CETIRIZINE HYDROCHLORIDE CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY, CETIRIZINE HYDROCHLORIDE (OTC) CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF, CETIRIZINE HYDROCHLORIDE (OTC) CHLORHEXIDINE GLUCONATE, CHLORHEXIDINE GLUCONATE CICLOPIROX, CICLOPIROX CLEMASTINE FUMARATE, CLEMASTINE FUMARATE CLINDAMYCIN PHOSPHATE, CLINDAMYCIN PHOSPHATE CLOBETASOL PROPIONATE, CLOBETASOL PROPIONATE CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE, BETAMETHASONE DIPROPIONATE CLOTRIMAZOLE, CLOTRIMAZOLE (OTC) CONSTULOSE, LACTULOSE CROMOLYN SODIUM, CROMOLYN SODIUM CROMOLYN SODIUM, CROMOLYN SODIUM (OTC) CYPROHEPTADINE HYDROCHLORIDE, CYPROHEPTADINE HYDROCHLORIDE ENULOSE, LACTULOSE FLUOCINONIDE, FLUOCINONIDE GRISEOFULVIN, GRISEOFULVIN, MICROCRYSTALLINE HALOBETASOL PROPIONATE, HALOBETASOL PROPIONATE HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE, HOMATROPINE METHYLBROMIDE HYDROCORTISONE, HYDROCORTISONE IBUPROFEN, IBUPROFEN IBUPROFEN, IBUPROFEN (OTC) INFANTS' FEVERALL, ACETAMINOPHEN (OTC) IPRATROPIUM BROMIDE, IPRATROPIUM BROMIDE LEVETIRACETAM, LEVETIRACETAM LIDOCAINE HYDROCHLORIDE VISCOUS, LIDOCAINE HYDROCHLORIDE MICONAZOLE 7, MICONAZOLE NITRATE (OTC) MICONAZOLE NITRATE, MICONAZOLE NITRATE MICONAZOLE NITRATE, MICONAZOLE NITRATE (OTC) MINOXIDIL (FOR MEN), MINOXIDIL (OTC) MINOXIDIL EXTRA STRENGTH (FOR MEN), MINOXIDIL (OTC) MYKACET, NYSTATIN M-ZOLE 3 COMBINATION PACK, MICONAZOLE NITRATE (OTC) M-ZOLE 7 DUAL PACK, MICONAZOLE NITRATE (OTC) NYSTATIN, NYSTATIN PERMETHRIN, PERMETHRIN PERMETHRIN, PERMETHRIN (OTC) PROMETH VC PLAIN, PHENYLEPHRINE HYDROCHLORIDE PROMETH VC W/ CODEINE, CODEINE PHOSPHATE PROMETH W/ DEXTROMETHORPHAN, DEXTROMETHORPHAN HYDROBROMIDE PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE, CODEINE PHOSPHATE SELENIUM SULFIDE, SELENIUM SULFIDE SULFATRIM PEDIATRIC, SULFAMETHOXAZOLE TRIAMCINOLONE ACETONIDE, TRIAMCINOLONE ACETONIDE
VALNAC, BETAMETHASONE VALERATE
ACTAVIS TOTOWA * ACTAVIS TOTOWA LLC ACETAMINOPHEN AND PENTAZOCINE HYDROCHLORIDE, ACETAMINOPHEN AMANTADINE HYDROCHLORIDE, AMANTADINE HYDROCHLORIDE AMLODIPINE BESYLATE, AMLODIPINE BESYLATE BACLOFEN, BACLOFEN BENZTROPINE MESYLATE, BENZTROPINE MESYLATE
BETHANECHOL CHLORIDE, BETHANECHOL CHLORIDE

SEPTEMBER 2010 - APPROVED DRUG PRODUCTS LIST

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APPENDIX B

PRODUCT NAME SORTED BY APPLICANT


** A **

* ACTAVIS TOTOWA LLC BICALUTAMIDE, BICALUTAMIDE BUSPIRONE HYDROCHLORIDE, BUSPIRONE HYDROCHLORIDE CARISOPRODOL AND ASPIRIN, ASPIRIN CARISOPRODOL, CARISOPRODOL CARISOPRODOL, ASPIRIN AND CODEINE PHOSPHATE, ASPIRIN CHLORZOXAZONE, CHLORZOXAZONE CILOSTAZOL, CILOSTAZOL CYCLOBENZAPRINE HYDROCHLORIDE, CYCLOBENZAPRINE HYDROCHLORIDE DANTROLENE SODIUM, DANTROLENE SODIUM DESIPRAMINE HYDROCHLORIDE, DESIPRAMINE HYDROCHLORIDE DIGOXIN, DIGOXIN DIPYRIDAMOLE, DIPYRIDAMOLE EPIRUBICIN HYDROCHLORIDE, EPIRUBICIN HYDROCHLORIDE FINASTERIDE, FINASTERIDE FLUDARABINE PHOSPHATE, FLUDARABINE PHOSPHATE GLYBURIDE, GLYBURIDE HYDROMORPHONE HYDROCHLORIDE, HYDROMORPHONE HYDROCHLORIDE HYDROXYZINE HYDROCHLORIDE, HYDROXYZINE HYDROCHLORIDE IMIPRAMINE HYDROCHLORIDE, IMIPRAMINE HYDROCHLORIDE IRINOTECAN HYDROCHLORIDE, IRINOTECAN HYDROCHLORIDE ISRADIPINE, ISRADIPINE MELOXICAM, MELOXICAM METHIMAZOLE, METHIMAZOLE MIRTAZAPINE, MIRTAZAPINE NALTREXONE HYDROCHLORIDE, NALTREXONE HYDROCHLORIDE OXYCODONE AND ACETAMINOPHEN, ACETAMINOPHEN OXYCODONE HYDROCHLORIDE, OXYCODONE HYDROCHLORIDE PACLITAXEL, PACLITAXEL PENTAZOCINE AND NALOXONE HYDROCHLORIDE, NALOXONE HYDROCHLORIDE PHENDIMETRAZINE TARTRATE, PHENDIMETRAZINE TARTRATE PHENTERMINE HYDROCHLORIDE, PHENTERMINE HYDROCHLORIDE PROMETHAZINE HYDROCHLORIDE, PROMETHAZINE HYDROCHLORIDE QUINAPRIL HYDROCHLORIDE, QUINAPRIL HYDROCHLORIDE QUINARETIC, HYDROCHLOROTHIAZIDE RIMACTANE, RIFAMPIN RIMANTADINE HYDROCHLORIDE, RIMANTADINE HYDROCHLORIDE RISPERIDONE, RISPERIDONE TIZANIDINE HYDROCHLORIDE, TIZANIDINE HYDROCHLORIDE TRIMETHOBENZAMIDE HYDROCHLORIDE, TRIMETHOBENZAMIDE HYDROCHLORIDE TRIMIPRAMINE MALEATE, TRIMIPRAMINE MALEATE VENLAFAXINE HYDROCHLORIDE, VENLAFAXINE HYDROCHLORIDE
VINORELBINE TARTRATE, VINORELBINE TARTRATE
ACTELION * ACTELION LTD EPOPROSTENOL SODIUM, TRACLEER, BOSENTAN

EPOPROSTENOL SODIUM

ACTELION PHARMS LTD * ACTELION PHARMACEUTICALS LTD VENTAVIS, ILOPROST


ZAVESCA, MIGLUSTAT
ACTON PHARMS * ACTON PHARMACEUTICALS INC AEROSPAN HFA, FLUNISOLIDE ADOLOR * ADOLOR CORP ENTEREG, ALVIMOPAN ADVENT PHARMS * ADVENT PHARMACEUTICALS INC CARISOPRODOL, CARISOPRODOL
IBUPROFEN, IBUPROFEN (OTC)

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APPENDIX B

PRODUCT NAME SORTED BY APPLICANT


** A **

AEGIS PHARMS * AEGIS PHARMACEUTICALS INC TAMOXIFEN CITRATE, TAMOXIFEN CITRATE AESGEN * AESGEN INC PAMIDRONATE DISODIUM,

PAMIDRONATE DISODIUM

AGOURON * AGOURON PHARMACEUTICALS INC VIRACEPT, NELFINAVIR MESYLATE AKORN * AKORN INC ADENOSINE, ADENOSINE AKBETA, LEVOBUNOLOL HYDROCHLORIDE AK-FLUOR 10%, FLUORESCEIN SODIUM AK-FLUOR 25%, FLUORESCEIN SODIUM AKPENTOLATE, CYCLOPENTOLATE HYDROCHLORIDE AKPRO, DIPIVEFRIN HYDROCHLORIDE AKTEN, LIDOCAINE HYDROCHLORIDE AKTOB, TOBRAMYCIN ALFENTA, ALFENTANIL HYDROCHLORIDE AMIODARONE HYDROCHLORIDE, AMIODARONE HYDROCHLORIDE BACITRACIN ZINC AND POLYMYXIN B SULFATE, BACITRACIN ZINC BAL, DIMERCAPROL BALANCED SALT, CALCIUM CHLORIDE BETAXOLOL HYDROCHLORIDE, BETAXOLOL HYDROCHLORIDE BRIMONIDINE TARTRATE, BRIMONIDINE TARTRATE CALCITRIOL, CALCITRIOL CAPASTAT SULFATE, CAPREOMYCIN SULFATE CARBOPLATIN, CARBOPLATIN CROMOLYN SODIUM, CROMOLYN SODIUM DICLOFENAC SODIUM, DICLOFENAC SODIUM ENDOSOL EXTRA, CALCIUM CHLORIDE GENTAK, GENTAMICIN SULFATE GENTAMICIN SULFATE, GENTAMICIN SULFATE HYDRALAZINE HYDROCHLORIDE, HYDRALAZINE HYDROCHLORIDE HYDROMORPHONE HYDROCHLORIDE, HYDROMORPHONE HYDROCHLORIDE IC-GREEN, INDOCYANINE GREEN IRINOTECAN HYDROCHLORIDE, IRINOTECAN HYDROCHLORIDE KETOROLAC TROMETHAMINE, KETOROLAC TROMETHAMINE KETOTIFEN FUMARATE, KETOTIFEN FUMARATE (OTC) LIDOCAINE HYDROCHLORIDE, LIDOCAINE HYDROCHLORIDE NEOMYCIN AND POLYMYXIN B SULFATES AND BACITRACIN ZINC, BACITRACIN ZINC OFLOXACIN, OFLOXACIN ORPHENADRINE CITRATE, ORPHENADRINE CITRATE PAREMYD, HYDROXYAMPHETAMINE HYDROBROMIDE SUBLIMAZE PRESERVATIVE FREE, FENTANYL CITRATE SUFENTA PRESERVATIVE FREE, SUFENTANIL CITRATE TERBUTALINE SULFATE, TERBUTALINE SULFATE TIMOLOL MALEATE, TIMOLOL MALEATE
TROPICACYL, TROPICAMIDE
AKORN INC * AKORN INC APRACLONIDINE HYDROCHLORIDE, APRACLONIDINE HYDROCHLORIDE CIPROFLOXACIN HYDROCHLORIDE, CIPROFLOXACIN HYDROCHLORIDE EPIRUBICIN HYDROCHLORIDE, EPIRUBICIN HYDROCHLORIDE GRANISETRON HYDROCHLORIDE, GRANISETRON HYDROCHLORIDE
INAPSINE, DROPERIDOL
AKORN STRIDES * AKORN STRIDES LLC DEXAMETHASONE SODIUM PHOSPHATE, DEXAMETHASONE SODIUM PHOSPHATE FAMOTIDINE PRESERVATIVE FREE, FAMOTIDINE
FAMOTIDINE, FAMOTIDINE

SEPTEMBER 2010 - APPROVED DRUG PRODUCTS LIST

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APPENDIX B

PRODUCT NAME SORTED BY APPLICANT


** A **

* AKORN STRIDES LLC FLUMAZENIL, FLUMAZENIL FOSPHENYTOIN SODIUM, FOSPHENYTOIN SODIUM HALOPERIDOL, HALOPERIDOL LACTATE KETOROLAC TROMETHAMINE, KETOROLAC TROMETHAMINE ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE, ONDANSETRON HYDROCHLORIDE ONDANSETRON HYDROCHLORIDE, ONDANSETRON HYDROCHLORIDE PAMIDRONATE DISODIUM, PAMIDRONATE DISODIUM RIFAMPIN, RIFAMPIN TOBRAMYCIN SULFATE, TOBRAMYCIN SULFATE
VANCOMYCIN HYDROCHLORIDE, VANCOMYCIN HYDROCHLORIDE
AKRIMAX PHARMS * AKRIMAX PHARMACEUTICALS LLC INDERAL LA, PROPRANOLOL HYDROCHLORIDE INDERAL, PROPRANOLOL HYDROCHLORIDE INDERIDE-40/25, HYDROCHLOROTHIAZIDE LO/OVRAL-28, ETHINYL ESTRADIOL
NITROMIST, NITROGLYCERIN
ALARA PHARM * ALARA PHARMACEUTICAL CORPORATION LEVO-T, LEVOTHYROXINE SODIUM ALAVEN PHARM * ALAVEN PHARMACEUTICAL LLC ANADROL-50, OXYMETHOLONE COLYTE WITH FLAVOR PACKS, POLYETHYLENE GLYCOL 3350 COLYTE, POLYETHYLENE GLYCOL 3350 COLYTE-FLAVORED, POLYETHYLENE GLYCOL 3350 REGLAN, METOCLOPRAMIDE HYDROCHLORIDE ROWASA, MESALAMINE
SFROWASA, MESALAMINE
ALCON * ALCON INC AZOPT, BRINZOLAMIDE BRIMONIDINE TARTRATE, BRIMONIDINE TARTRATE CILOXAN, CIPROFLOXACIN HYDROCHLORIDE CIPRO HC, CIPROFLOXACIN HYDROCHLORIDE CIPRODEX, CIPROFLOXACIN DICLOFENAC SODIUM, DICLOFENAC SODIUM DORZOLAMIDE HYDROCHLORIDE, DORZOLAMIDE HYDROCHLORIDE FLUORESCITE, FLUORESCEIN SODIUM KETOROLAC TROMETHAMINE, KETOROLAC TROMETHAMINE KETOTIFEN FUMARATE, KETOTIFEN FUMARATE (OTC) NAVSTEL, CALCIUM CHLORIDE NEVANAC, NEPAFENAC OFLOXACIN, OFLOXACIN PATADAY, OLOPATADINE HYDROCHLORIDE PATANASE, OLOPATADINE HYDROCHLORIDE SULFACETAMIDE SODIUM AND PREDNISOLONE SODIUM PHOSPHATE, TOBRADEX ST, DEXAMETHASONE TRAVATAN Z, TRAVOPROST TRAVATAN, TRAVOPROST TRIESENCE, TRIAMCINOLONE ACETONIDE
VIGAMOX, MOXIFLOXACIN HYDROCHLORIDE
* ALCON LABORATORIES INC ALCAINE, PROPARACAINE HYDROCHLORIDE ALOMIDE, LODOXAMIDE TROMETHAMINE BETADINE, POVIDONE-IODINE BETOPTIC S, BETAXOLOL HYDROCHLORIDE BETOPTIC, BETAXOLOL HYDROCHLORIDE BSS PLUS, CALCIUM CHLORIDE BSS, CALCIUM CHLORIDE CARTEOLOL HYDROCHLORIDE, CARTEOLOL HYDROCHLORIDE
CETAMIDE, SULFACETAMIDE SODIUM

PREDNISOLONE SODIUM PHOSPHATE

SEPTEMBER 2010 - APPROVED DRUG PRODUCTS LIST

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APPENDIX B

PRODUCT NAME SORTED BY APPLICANT


** A **

* ALCON LABORATORIES INC CROMOLYN SODIUM, CROMOLYN SODIUM CYCLOGYL, CYCLOPENTOLATE HYDROCHLORIDE CYCLOMYDRIL, CYCLOPENTOLATE HYDROCHLORIDE DENDRID, IDOXURIDINE EMADINE, EMEDASTINE DIFUMARATE FLAREX, FLUOROMETHOLONE ACETATE IOPIDINE, APRACLONIDINE HYDROCHLORIDE MAXIDEX, DEXAMETHASONE MAXITROL, DEXAMETHASONE MIOSTAT, CARBACHOL MYDRIACYL, TROPICAMIDE NAPHCON-A, NAPHAZOLINE HYDROCHLORIDE (OTC) NATACYN, NATAMYCIN NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE, OMNIPRED, PREDNISOLONE ACETATE PATANOL, OLOPATADINE HYDROCHLORIDE PILOPINE HS, PILOCARPINE HYDROCHLORIDE TOBRADEX, DEXAMETHASONE TOBREX, TOBRAMYCIN TRIFLURIDINE, TRIFLURIDINE
VEXOL, RIMEXOLONE
ALCON RES * ALCON RESEARCH LTD BRIMONIDINE TARTRATE, BRIMONIDINE TARTRATE DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE,

HYDROCORTISONE

DORZOLAMIDE HYDROCHLORIDE

ALCON UNIVERSAL * ALCON UNIVERSAL LTD DEXAMETHASONE SODIUM PHOSPHATE, DEXAMETHASONE SODIUM PHOSPHATE NEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONE, DEXAMETHASONE NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE, HYDROCORTISONE
SULFACETAMIDE SODIUM, SULFACETAMIDE SODIUM
ALEMBIC LTD * ALEMBIC LTD FAMOTIDINE, FAMOTIDINE FLUOXETINE HYDROCHLORIDE, FLUOXETINE HYDROCHLORIDE LITHIUM CARBONATE, LITHIUM CARBONATE MEPROBAMATE, MEPROBAMATE METRONIDAZOLE, METRONIDAZOLE
ROPINIROLE HYDROCHLORIDE, ROPINIROLE HYDROCHLORIDE
ALKEM * ALKEM LABORATORIES LTD AMLODIPINE BESYLATE, ALKERMES * ALKERMES INC VIVITROL, NALTREXONE ALLEGIANCE HLTHCARE * ALLEGIANCE HEALTHCARE CORP POVIDONE IODINE, POVIDONE-IODINE

AMLODIPINE BESYLATE

(OTC)

ALLERGAN * ALLERGAN ACULAR LS, KETOROLAC TROMETHAMINE ALPHAGAN P, BRIMONIDINE TARTRATE BLEPH-10, SULFACETAMIDE SODIUM
GENOPTIC, GENTAMICIN SULFATE
* ALLERGAN INC ACULAR PRESERVATIVE FREE, KETOROLAC TROMETHAMINE ACULAR, KETOROLAC TROMETHAMINE ACUVAIL, KETOROLAC TROMETHAMINE ACZONE, DAPSONE ALBALON, NAPHAZOLINE HYDROCHLORIDE
ALOCRIL, NEDOCROMIL SODIUM

SEPTEMBER 2010 - APPROVED DRUG PRODUCTS LIST

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APPENDIX B

PRODUCT NAME SORTED BY APPLICANT


** A **

* ALLERGAN INC ALPHAGAN P, BRIMONIDINE TARTRATE AVAGE, TAZAROTENE AZELEX, AZELAIC ACID COMBIGAN, BRIMONIDINE TARTRATE ELESTAT, EPINASTINE HYDROCHLORIDE ELIMITE, PERMETHRIN LATISSE, BIMATOPROST LUMIGAN, BIMATOPROST OCUFLOX, OFLOXACIN OPTICROM, CROMOLYN SODIUM OZURDEX, DEXAMETHASONE POLYTRIM, POLYMYXIN B SULFATE RESTASIS, CYCLOSPORINE SANCTURA XR, TROSPIUM CHLORIDE SANCTURA, TROSPIUM CHLORIDE TAZORAC, TAZAROTENE TRIVARIS, TRIAMCINOLONE ACETONIDE
ZYMAR, GATIFLOXACIN
* ALLERGAN PHARMACEUTICAL BETAGAN, LEVOBUNOLOL HYDROCHLORIDE BLEPHAMIDE S.O.P., PREDNISOLONE ACETATE BLEPHAMIDE, PREDNISOLONE ACETATE FML FORTE, FLUOROMETHOLONE FML, FLUOROMETHOLONE HERPLEX, IDOXURIDINE OCUFEN, FLURBIPROFEN SODIUM OPHTHETIC, PROPARACAINE HYDROCHLORIDE POLY-PRED, NEOMYCIN SULFATE PRED FORTE, PREDNISOLONE ACETATE PRED MILD, PREDNISOLONE ACETATE PRED-G, GENTAMICIN SULFATE
PROPINE, DIPIVEFRIN HYDROCHLORIDE
ALLERGAN HERBERT * ALLERGAN HERBERT SKIN CARE DIV ALLERGAN INC FLUOROPLEX, FLUOROURACIL ALLERQUEST * ALLERQUEST LLC PRE-PEN, BENZYLPENICILLOYL POLYLYSINE ALLOS * ALLOS THERAPEUTICS INC FOLOTYN, PRALATREXATE ALPHAPHARM * ALPHAPHARM PARTY LTD ALPRAZOLAM, ALPRAZOLAM CILOSTAZOL, CILOSTAZOL CITALOPRAM HYDROBROMIDE, CITALOPRAM HYDROBROMIDE CLONAZEPAM, CLONAZEPAM DICLOFENAC SODIUM, DICLOFENAC SODIUM ESCITALOPRAM OXALATE, ESCITALOPRAM OXALATE FLUOXETINE HYDROCHLORIDE, FLUOXETINE HYDROCHLORIDE GLIPIZIDE, GLIPIZIDE INDAPAMIDE, INDAPAMIDE METFORMIN HYDROCHLORIDE, METFORMIN HYDROCHLORIDE MIRTAZAPINE, MIRTAZAPINE NAPROXEN, NAPROXEN TIZANIDINE HYDROCHLORIDE, TIZANIDINE HYDROCHLORIDE TRAMADOL HYDROCHLORIDE, TRAMADOL HYDROCHLORIDE TRIAZOLAM, TRIAZOLAM
ZONISAMIDE, ZONISAMIDE
* ALPHAPHARM PTY LTD ANAGRELIDE HYDROCHLORIDE, ANAGRELIDE HYDROCHLORIDE
PAROXETINE HYDROCHLORIDE, PAROXETINE HYDROCHLORIDE

SEPTEMBER 2010 - APPROVED DRUG PRODUCTS LIST

B - 10

APPENDIX B

PRODUCT NAME SORTED BY APPLICANT


** A **

ALPHARMA * ALPHARMA USPD INC PREDNISOLONE, PREDNISOLONE


VALPROIC ACID, VALPROIC ACID
ALPHARMA KING * ALPHARMA PHARMACEUTICALS LLC KING PHARMACEUTICALS EMBEDA, MORPHINE SULFATE ALPHARMA US PHARMS * ALPHARMA US PHARMACEUTICALS DIVISION RANITIDINE HYDROCHLORIDE, RANITIDINE HYDROCHLORIDE ALRA * ALRA LABORATORIES INC CHOLAC, LACTULOSE CONSTILAC, LACTULOSE GEN-XENE, CLORAZEPATE DIPOTASSIUM IBU-TAB 200, IBUPROFEN (OTC)
IBU-TAB, IBUPROFEN
ALTANA * ALTANA INC ALCLOMETASONE DIPROPIONATE, ALCLOMETASONE DIPROPIONATE AMCINONIDE, AMCINONIDE BACITRACIN ZINC AND POLYMYXIN B SULFATE, BACITRACIN ZINC BACITRACIN, BACITRACIN BETAMETHASONE DIPROPIONATE, BETAMETHASONE DIPROPIONATE CICLOPIROX, CICLOPIROX CLINDAMYCIN PHOSPHATE, CLINDAMYCIN PHOSPHATE CLOBETASOL PROPIONATE (EMOLLIENT), CLOBETASOL PROPIONATE CLOBETASOL PROPIONATE, CLOBETASOL PROPIONATE CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE, BETAMETHASONE DIPROPIONATE CUTIVATE, FLUTICASONE PROPIONATE DESONIDE, DESONIDE DIFLORASONE DIACETATE, DIFLORASONE DIACETATE ECONAZOLE NITRATE, ECONAZOLE NITRATE ERYTHROMYCIN, ERYTHROMYCIN FLUOCINONIDE EMULSIFIED BASE, FLUOCINONIDE FLUOCINONIDE, FLUOCINONIDE FLUTICASONE PROPIONATE, FLUTICASONE PROPIONATE GENTAMICIN SULFATE, GENTAMICIN SULFATE HALOBETASOL PROPIONATE, HALOBETASOL PROPIONATE HYDROCORTISONE VALERATE, HYDROCORTISONE VALERATE HYDROCORTISONE, HYDROCORTISONE KETOCONAZOLE, KETOCONAZOLE METRONIDAZOLE, METRONIDAZOLE MOMETASONE FUROATE, MOMETASONE FUROATE MUPIROCIN, MUPIROCIN NEOMYCIN AND POLYMYXIN B SULFATES AND BACITRACIN ZINC, BACITRACIN ZINC NYSTATIN, NYSTATIN OXISTAT, OXICONAZOLE NITRATE PREDNICARBATE, PREDNICARBATE SULFACETAMIDE SODIUM, SULFACETAMIDE SODIUM TEMOVATE E, CLOBETASOL PROPIONATE TEMOVATE, CLOBETASOL PROPIONATE TERCONAZOLE, TERCONAZOLE TOBRAMYCIN, TOBRAMYCIN
TRIAMCINOLONE ACETONIDE, TRIAMCINOLONE ACETONIDE
ALTANA PHARMA * ALTANA PHARMA AG CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE, ALTERNA TCHP LLC * ALTERNA TCHP LLC CHILDREN'S ELIXSURE,

BETAMETHASONE DIPROPIONATE

IBUPROFEN

(OTC)

SEPTEMBER 2010 - APPROVED DRUG PRODUCTS LIST

B - 11

APPENDIX B
ALVOGEN * ALVOGEN INC METFORMIN HYDROCHLORIDE, TRAZODONE HYDROCHLORIDE,

PRODUCT NAME SORTED BY APPLICANT


** A **

METFORMIN HYDROCHLORIDE
TRAZODONE HYDROCHLORIDE

AMAG PHARMS INC * AMAG PHARMACEUTICALS INC FERAHEME, FERUMOXYTOL FERIDEX I.V., FERUMOXIDES
GASTROMARK, FERUMOXSIL
AMGEN * AMGEN INC SENSIPAR,

CINACALCET HYDROCHLORIDE

AMIDE PHARM * ACTAVIS TOTOWA LLC DESIPRAMINE HYDROCHLORIDE,

DESIPRAMINE HYDROCHLORIDE

AMNEAL PHARM * AMNEAL PHARMACEUTICAL ACEBUTOLOL HYDROCHLORIDE, ACEBUTOLOL HYDROCHLORIDE BETHANECHOL CHLORIDE, BETHANECHOL CHLORIDE DEMECLOCYCLINE HYDROCHLORIDE, DEMECLOCYCLINE HYDROCHLORIDE FLECAINIDE ACETATE, FLECAINIDE ACETATE GUANFACINE HYDROCHLORIDE, GUANFACINE HYDROCHLORIDE HYDROXYZINE HYDROCHLORIDE, HYDROXYZINE HYDROCHLORIDE NICARDIPINE HYDROCHLORIDE, NICARDIPINE HYDROCHLORIDE PRIMIDONE, PRIMIDONE
SOTALOL HYDROCHLORIDE, SOTALOL HYDROCHLORIDE
AMNEAL PHARMS * AMNEAL PHARMACEUTICALS CETIRIZINE HYDROCHLORIDE, CETIRIZINE HYDROCHLORIDE CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY, CETIRIZINE HYDROCHLORIDE (OTC) CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF, CETIRIZINE HYDROCHLORIDE (OTC) LEVETIRACETAM, LEVETIRACETAM LORAZEPAM, LORAZEPAM NIZATIDINE, NIZATIDINE PREDNISOLONE SODIUM PHOSPHATE, PREDNISOLONE SODIUM PHOSPHATE PROMETHAZINE HYDROCHLORIDE AND PHENYLEPHRINE HYDROCHLORIDE, PHENYLEPHRINE HYDROCHLORIDE PROMETHAZINE HYDROCHLORIDE, PROMETHAZINE HYDROCHLORIDE RANITIDINE HYDROCHLORIDE, RANITIDINE HYDROCHLORIDE
TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN, ACETAMINOPHEN
* AMNEAL PHARMACEUTICALS LLC TRAMADOL HYDROCHLORIDE, TRAMADOL HYDROCHLORIDE AMNEAL PHARMS NY * AMNEAL PHARMACEUTICALS NY LLC ACETAMINOPHEN AND CODEINE PHOSPHATE, ACETAMINOPHEN ALPRAZOLAM, ALPRAZOLAM AMLODIPINE BESYLATE, AMLODIPINE BESYLATE CETIRIZINE HYDROCHLORIDE ALLERGY, CETIRIZINE HYDROCHLORIDE (OTC) CETIRIZINE HYDROCHLORIDE HIVES RELIEF, CETIRIZINE HYDROCHLORIDE (OTC) CITALOPRAM HYDROBROMIDE, CITALOPRAM HYDROBROMIDE EXTENDED PHENYTOIN SODIUM, PHENYTOIN SODIUM GABAPENTIN, GABAPENTIN HYDROCODONE BITARTRATE AND ACETAMINOPHEN, ACETAMINOPHEN HYDROCODONE BITARTRATE AND IBUPROFEN, HYDROCODONE BITARTRATE IBUPROFEN, IBUPROFEN IBUPROFEN, IBUPROFEN (OTC) METFORMIN HYDROCHLORIDE, METFORMIN HYDROCHLORIDE NAPROXEN SODIUM, NAPROXEN SODIUM NAPROXEN SODIUM, NAPROXEN SODIUM (OTC) NAPROXEN, NAPROXEN OXYCODONE AND ACETAMINOPHEN, ACETAMINOPHEN RANITIDINE HYDROCHLORIDE, RANITIDINE HYDROCHLORIDE
REPREXAIN, HYDROCODONE BITARTRATE

SEPTEMBER 2010 - APPROVED DRUG PRODUCTS LIST

B - 12

APPENDIX B

PRODUCT NAME SORTED BY APPLICANT


** A **
SULFAMETHOXAZOLE

* AMNEAL PHARMACEUTICALS NY LLC SULFAMETHOXAZOLE AND TRIMETHOPRIM, AMPHASTAR * AMPHASTAR PHARMACEUTICALS INC CORTROSYN, COSYNTROPIN AMPHASTAR PHARM * AMPHASTAR PHARMACEUTICAL INC AMPHADASE, HYALURONIDASE AMYLIN * AMYLIN PHARMACEUTICALS INC BYETTA, EXENATIDE SYNTHETIC
SYMLIN, PRAMLINTIDE ACETATE
ANBEX * ANBEX INC IOSAT, POTASSIUM IODIDE

(OTC)

ANCHEN PHARMS * ANCHEN PHARMACEUTICALS INC BUPROPION HYDROCHLORIDE, BUPROPION HYDROCHLORIDE * ANCHEN PHARMACEUTICALS TAIWAN INC DIVALPROEX SODIUM, DIVALPROEX SODIUM ANDAPHARM * ANDAPHARM LLC HYDROXYZINE HYDROCHLORIDE,

HYDROXYZINE HYDROCHLORIDE

ANDRX LABS LLC * ANDRX LABS LLC ALTOPREV, LOVASTATIN


FORTAMET, METFORMIN HYDROCHLORIDE
ANESTA AG * ANESTA AG AMRIX, CYCLOBENZAPRINE HYDROCHLORIDE ANI PHARMS * ANI PHARMACEUTICALS INC CORTENEMA, HYDROCORTISONE LACTULOSE, LACTULOSE
METOCLOPRAMIDE HYDROCHLORIDE,

METOCLOPRAMIDE HYDROCHLORIDE

APOTEX * APOTEX CORP PRAVASTATIN SODIUM, PRAVASTATIN SODIUM


TERBINAFINE HYDROCHLORIDE, TERBINAFINE HYDROCHLORIDE
* APOTEX INC ALENDRONATE SODIUM, ALENDRONATE SODIUM AMLODIPINE BESYLATE, AMLODIPINE BESYLATE AMOXICILLIN AND CLAVULANATE POTASSIUM, AMOXICILLIN BUDESONIDE, BUDESONIDE BUSPIRONE HYDROCHLORIDE, BUSPIRONE HYDROCHLORIDE CAPTOPRIL, CAPTOPRIL CARBIDOPA AND LEVODOPA, CARBIDOPA CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY, CETIRIZINE HYDROCHLORIDE (OTC) CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF, CETIRIZINE HYDROCHLORIDE (OTC) CIMETIDINE, CIMETIDINE CIPROFLOXACIN HYDROCHLORIDE, CIPROFLOXACIN HYDROCHLORIDE CLONAZEPAM, CLONAZEPAM CYCLOSPORINE, CYCLOSPORINE DICLOFENAC POTASSIUM, DICLOFENAC POTASSIUM DILT-CD, DILTIAZEM HYDROCHLORIDE DILTIAZEM HYDROCHLORIDE, DILTIAZEM HYDROCHLORIDE DOXAZOSIN MESYLATE, DOXAZOSIN MESYLATE ENALAPRIL MALEATE, ENALAPRIL MALEATE EPLERENONE, EPLERENONE ETODOLAC, ETODOLAC
FAMOTIDINE, FAMOTIDINE

SEPTEMBER 2010 - APPROVED DRUG PRODUCTS LIST

B - 13

APPENDIX B

PRODUCT NAME SORTED BY APPLICANT


** A **

* APOTEX INC FLUCONAZOLE, FLUCONAZOLE FLUVOXAMINE MALEATE, FLUVOXAMINE MALEATE GEMFIBROZIL, GEMFIBROZIL GLIPIZIDE, GLIPIZIDE HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE KETOCONAZOLE, KETOCONAZOLE METFORMIN HYDROCHLORIDE, METFORMIN HYDROCHLORIDE MYCOPHENOLATE MOFETIL, MYCOPHENOLATE MOFETIL NIZATIDINE, NIZATIDINE OMEPRAZOLE, OMEPRAZOLE ONDANSETRON HYDROCHLORIDE, ONDANSETRON HYDROCHLORIDE PAROXETINE HYDROCHLORIDE, PAROXETINE HYDROCHLORIDE PENTOXIFYLLINE, PENTOXIFYLLINE QUINAPRIL HYDROCHLORIDE, QUINAPRIL HYDROCHLORIDE RAMIPRIL, RAMIPRIL RANITIDINE HYDROCHLORIDE, RANITIDINE HYDROCHLORIDE SELEGILINE HYDROCHLORIDE, SELEGILINE HYDROCHLORIDE SOTALOL HYDROCHLORIDE, SOTALOL HYDROCHLORIDE TERAZOSIN HYDROCHLORIDE, TERAZOSIN HYDROCHLORIDE TICLOPIDINE HYDROCHLORIDE, TICLOPIDINE HYDROCHLORIDE TIZANIDINE HYDROCHLORIDE, TIZANIDINE HYDROCHLORIDE TRAMADOL HYDROCHLORIDE, TRAMADOL HYDROCHLORIDE
TRAZODONE HYDROCHLORIDE, TRAZODONE HYDROCHLORIDE
APOTEX CORP * APOTEX CORP ALBUTEROL SULFATE AND IPRATROPIUM BROMIDE, ALBUTEROL SULFATE AMIODARONE HYDROCHLORIDE, AMIODARONE HYDROCHLORIDE CICLOPIROX, CICLOPIROX CLARITHROMYCIN, CLARITHROMYCIN GRANISETRON HYDROCHLORIDE, GRANISETRON HYDROCHLORIDE
MYCOPHENOLATE MOFETIL, MYCOPHENOLATE MOFETIL
APOTEX INC * APOTEX INC ALBUTEROL SULFATE, ALBUTEROL SULFATE ALPRAZOLAM, ALPRAZOLAM AZELASTINE HYDROCHLORIDE, AZELASTINE HYDROCHLORIDE CALCITONIN-SALMON, CALCITONIN SALMON CARBIDOPA AND LEVODOPA, CARBIDOPA CEFPROZIL, CEFPROZIL CETIRIZINE HYDROCHLORIDE ALLERGY, CETIRIZINE HYDROCHLORIDE (OTC) CETIRIZINE HYDROCHLORIDE, CETIRIZINE HYDROCHLORIDE DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE, DORZOLAMIDE HYDROCHLORIDE DORZOLAMIDE HYDROCHLORIDE, DORZOLAMIDE HYDROCHLORIDE FLECAINIDE ACETATE, FLECAINIDE ACETATE GRANISETRON HYDROCHLORIDE, GRANISETRON HYDROCHLORIDE LAMOTRIGINE, LAMOTRIGINE LEVETIRACETAM, LEVETIRACETAM LOVASTATIN, LOVASTATIN MOEXIPRIL HYDROCHLORIDE, MOEXIPRIL HYDROCHLORIDE OFLOXACIN, OFLOXACIN OXCARBAZEPINE, OXCARBAZEPINE PAROXETINE HYDROCHLORIDE, PAROXETINE HYDROCHLORIDE RISPERIDONE, RISPERIDONE SERTRALINE HYDROCHLORIDE, SERTRALINE HYDROCHLORIDE TRAZODONE HYDROCHLORIDE, TRAZODONE HYDROCHLORIDE TRIAMTERENE AND HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE
ZOLPIDEM TARTRATE, ZOLPIDEM TARTRATE
* APOTEX INC ETOBICOKE SITE ACYCLOVIR, ACYCLOVIR ALLOPURINOL, ALLOPURINOL AMOXICILLIN AND CLAVULANATE POTASSIUM, AMOXICILLIN BALSALAZIDE DISODIUM, BALSALAZIDE DISODIUM
BENAZEPRIL HYDROCHLORIDE, BENAZEPRIL HYDROCHLORIDE

SEPTEMBER 2010 - APPROVED DRUG PRODUCTS LIST

B - 14

APPENDIX B

PRODUCT NAME SORTED BY APPLICANT


** A **

* APOTEX INC ETOBICOKE SITE BUPROPION HYDROCHLORIDE, BUPROPION HYDROCHLORIDE CARBAMAZEPINE, CARBAMAZEPINE CARVEDILOL, CARVEDILOL CEFUROXIME AXETIL, CEFUROXIME AXETIL CILOSTAZOL, CILOSTAZOL CITALOPRAM HYDROBROMIDE, CITALOPRAM HYDROBROMIDE DESMOPRESSIN ACETATE, DESMOPRESSIN ACETATE DILTZAC, DILTIAZEM HYDROCHLORIDE ENALAPRIL MALEATE AND HYDROCHLOROTHIAZIDE, ENALAPRIL MALEATE ETODOLAC, ETODOLAC FOSINOPRIL SODIUM, FOSINOPRIL SODIUM GABAPENTIN, GABAPENTIN KETOTIFEN FUMARATE, KETOTIFEN FUMARATE (OTC) LEFLUNOMIDE, LEFLUNOMIDE LISINOPRIL AND HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE LISINOPRIL, LISINOPRIL LITHIUM CARBONATE, LITHIUM CARBONATE LORATADINE, LORATADINE (OTC) MELOXICAM, MELOXICAM METFORMIN HYDROCHLORIDE, METFORMIN HYDROCHLORIDE MIDODRINE HYDROCHLORIDE, MIDODRINE HYDROCHLORIDE MIRTAZAPINE, MIRTAZAPINE OXAPROZIN, OXAPROZIN SELEGILINE HYDROCHLORIDE, SELEGILINE HYDROCHLORIDE SOTALOL HYDROCHLORIDE, SOTALOL HYDROCHLORIDE TOPIRAMATE, TOPIRAMATE TORSEMIDE, TORSEMIDE
ZONISAMIDE, ZONISAMIDE
* APOTEX INC RICHMOND HILL ALBUTEROL SULFATE, ALBUTEROL SULFATE AMIODARONE HYDROCHLORIDE, AMIODARONE HYDROCHLORIDE AZELASTINE HYDROCHLORIDE, AZELASTINE HYDROCHLORIDE BUTORPHANOL TARTRATE PRESERVATIVE FREE, BUTORPHANOL TARTRATE BUTORPHANOL TARTRATE, BUTORPHANOL TARTRATE DESMOPRESSIN ACETATE (NEEDS NO REFRIGERATION), DESMOPRESSIN ACETATE DICLOFENAC SODIUM, DICLOFENAC SODIUM DILTIAZEM HYDROCHLORIDE, DILTIAZEM HYDROCHLORIDE DIPYRIDAMOLE, DIPYRIDAMOLE FAMOTIDINE PRESERVATIVE FREE (PHARMACY BULK), FAMOTIDINE FAMOTIDINE PRESERVATIVE FREE, FAMOTIDINE FLUCONAZOLE IN DEXTROSE 5% IN PLASTIC CONTAINER, FLUCONAZOLE FLUMAZENIL, FLUMAZENIL FLUNISOLIDE, FLUNISOLIDE FLUPHENAZINE DECANOATE, FLUPHENAZINE DECANOATE FLUTICASONE PROPIONATE, FLUTICASONE PROPIONATE FOSPHENYTOIN SODIUM, FOSPHENYTOIN SODIUM HALOPERIDOL DECANOATE, HALOPERIDOL DECANOATE HALOPERIDOL, HALOPERIDOL LACTATE KETOROLAC TROMETHAMINE, KETOROLAC TROMETHAMINE LABETALOL HYDROCHLORIDE, LABETALOL HYDROCHLORIDE LORATADINE, LORATADINE (OTC) MEGESTROL ACETATE, MEGESTROL ACETATE MIDAZOLAM HYDROCHLORIDE, MIDAZOLAM HYDROCHLORIDE MILRINONE LACTATE IN DEXTROSE 5% IN PLASTIC CONTAINER, MILRINONE LACTATE MILRINONE LACTATE IN DEXTROSE 5%, MILRINONE LACTATE MILRINONE LACTATE, MILRINONE LACTATE ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE, ONDANSETRON HYDROCHLORIDE PREDNISOLONE, PREDNISOLONE RISPERIDONE, RISPERIDONE
VALPROIC ACID, VALPROIC ACID
APOTHECON * APOTHECON INC DIV BRISTOL MYERS SQUIBB CAPOZIDE 25/15, CAPTOPRIL

SEPTEMBER 2010 - APPROVED DRUG PRODUCTS LIST

B - 15

APPENDIX B

PRODUCT NAME SORTED BY APPLICANT


** A **

* APOTHECON INC DIV BRISTOL MYERS SQUIBB CAPOZIDE 25/25, CAPTOPRIL CAPOZIDE 50/15, CAPTOPRIL CAPOZIDE 50/25, CAPTOPRIL FUNGIZONE, AMPHOTERICIN B KENALOG, TRIAMCINOLONE ACETONIDE KENALOG-10, TRIAMCINOLONE ACETONIDE KENALOG-40, TRIAMCINOLONE ACETONIDE KLOTRIX, POTASSIUM CHLORIDE OPHTHAINE, PROPARACAINE HYDROCHLORIDE PRINCIPEN, AMPICILLIN/AMPICILLIN TRIHYDRATE STADOL PRESERVATIVE FREE, BUTORPHANOL TARTRATE STADOL, BUTORPHANOL TARTRATE
TOBRAMYCIN SULFATE, TOBRAMYCIN SULFATE
APP PHARMS * APP PHARMACEUTICALS GRANISETRON HYDROCHLORIDE PRESERVATIVE FREE, GRANISETRON HYDROCHLORIDE IRINOTECAN HYDROCHLORIDE, IRINOTECAN HYDROCHLORIDE
PROTAMINE SULFATE, PROTAMINE SULFATE
* APP PHARMACEUTICALS LLC ACYCLOVIR SODIUM, ACYCLOVIR SODIUM ADENOSINE, ADENOSINE AMIODARONE HYDROCHLORIDE, AMIODARONE HYDROCHLORIDE ASTRAMORPH PF, MORPHINE SULFATE AZITHROMYCIN, AZITHROMYCIN BACITRACIN, BACITRACIN BACTERIOSTATIC SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, SODIUM CHLORIDE BLEOMYCIN SULFATE, BLEOMYCIN SULFATE CAFFEINE CITRATE, CAFFEINE CITRATE CALCITRIOL, CALCITRIOL CARBOPLATIN, CARBOPLATIN CEFAZOLIN SODIUM, CEFAZOLIN SODIUM CEFOTAXIME, CEFOTAXIME SODIUM CEFOTETAN, CEFOTETAN DISODIUM CEFOXITIN, CEFOXITIN SODIUM CEFTRIAXONE, CEFTRIAXONE SODIUM CEFUROXIME SODIUM, CEFUROXIME SODIUM CHLORAMPHENICOL SODIUM SUCCINATE, CHLORAMPHENICOL SODIUM SUCCINATE CHLOROTHIAZIDE SODIUM, CHLOROTHIAZIDE SODIUM CHORIONIC GONADOTROPIN, GONADOTROPIN, CHORIONIC CISPLATIN, CISPLATIN CLADRIBINE, CLADRIBINE CLINDAMYCIN PHOSPHATE, CLINDAMYCIN PHOSPHATE COLISTIMETHATE SODIUM, COLISTIMETHATE SODIUM CYTARABINE, CYTARABINE DACARBAZINE, DACARBAZINE DAUNORUBICIN HYDROCHLORIDE, DAUNORUBICIN HYDROCHLORIDE DEFEROXAMINE MESYLATE, DEFEROXAMINE MESYLATE DEXAMETHASONE SODIUM PHOSPHATE, DEXAMETHASONE SODIUM PHOSPHATE DIMENHYDRINATE, DIMENHYDRINATE DIPHENHYDRAMINE HYDROCHLORIDE, DIPHENHYDRAMINE HYDROCHLORIDE DIPRIVAN, PROPOFOL DIPYRIDAMOLE, DIPYRIDAMOLE DOXORUBICIN HYDROCHLORIDE, DOXORUBICIN HYDROCHLORIDE DOXY 100, DOXYCYCLINE HYCLATE DOXY 200, DOXYCYCLINE HYCLATE EMLA, LIDOCAINE EPIRUBICIN HYDROCHLORIDE, EPIRUBICIN HYDROCHLORIDE ESMOLOL HYDROCHLORIDE, ESMOLOL HYDROCHLORIDE ETOPOSIDE, ETOPOSIDE FAMOTIDINE PRESERVATIVE FREE, FAMOTIDINE FAMOTIDINE, FAMOTIDINE FLOXURIDINE, FLOXURIDINE
FLUCONAZOLE IN SODIUM CHLORIDE 0.9%, FLUCONAZOLE

SEPTEMBER 2010 - APPROVED DRUG PRODUCTS LIST

B - 16

APPENDIX B

PRODUCT NAME SORTED BY APPLICANT


** A **

* APP PHARMACEUTICALS LLC FLUDARABINE PHOSPHATE, FLUDARABINE PHOSPHATE FLUMAZENIL, FLUMAZENIL FLUOROURACIL, FLUOROURACIL FLUPHENAZINE DECANOATE, FLUPHENAZINE DECANOATE FLUPHENAZINE HYDROCHLORIDE, FLUPHENAZINE HYDROCHLORIDE FOLIC ACID, FOLIC ACID FOSPHENYTOIN SODIUM, FOSPHENYTOIN SODIUM FUROSEMIDE, FUROSEMIDE GENTAMICIN SULFATE, GENTAMICIN SULFATE GRANISETRON HYDROCHLORIDE, GRANISETRON HYDROCHLORIDE HALOPERIDOL DECANOATE, HALOPERIDOL DECANOATE HALOPERIDOL, HALOPERIDOL LACTATE HEPARIN SODIUM IN PLASTIC CONTAINER, HEPARIN SODIUM HEPARIN SODIUM PRESERVATIVE FREE, HEPARIN SODIUM HEPARIN SODIUM, HEPARIN SODIUM HYDRALAZINE HYDROCHLORIDE, HYDRALAZINE HYDROCHLORIDE HYDROXYZINE HYDROCHLORIDE, HYDROXYZINE HYDROCHLORIDE IDARUBICIN HYDROCHLORIDE, IDARUBICIN HYDROCHLORIDE IFOSFAMIDE, IFOSFAMIDE INDOMETHACIN, INDOMETHACIN IOPAMIDOL-250, IOPAMIDOL IOPAMIDOL-300, IOPAMIDOL IOPAMIDOL-370, IOPAMIDOL KANAMYCIN SULFATE, KANAMYCIN SULFATE KETOROLAC TROMETHAMINE, KETOROLAC TROMETHAMINE LEUCOVORIN CALCIUM PRESERVATIVE FREE, LEUCOVORIN CALCIUM LIDOCAINE HYDROCHLORIDE IN PLASTIC CONTAINER, LIDOCAINE HYDROCHLORIDE LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE, LIDOCAINE HYDROCHLORIDE MANNITOL 25%, MANNITOL MESNA, MESNA METARAMINOL BITARTRATE, METARAMINOL BITARTRATE METHOTREXATE SODIUM, METHOTREXATE SODIUM METHYLPREDNISOLONE SODIUM SUCCINATE, METHYLPREDNISOLONE SODIUM SUCCINATE MIDAZOLAM HYDROCHLORIDE, MIDAZOLAM HYDROCHLORIDE MILRINONE LACTATE, MILRINONE LACTATE MITOXANTRONE HYDROCHLORIDE, MITOXANTRONE HYDROCHLORIDE NAROPIN, ROPIVACAINE HYDROCHLORIDE MONOHYDRATE NEBUPENT, PENTAMIDINE ISETHIONATE NESACAINE, CHLOROPROCAINE HYDROCHLORIDE NESACAINE-MPF, CHLOROPROCAINE HYDROCHLORIDE OCTREOTIDE ACETATE (PRESERVATIVE FREE), OCTREOTIDE ACETATE OCTREOTIDE ACETATE, OCTREOTIDE ACETATE ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE, ONDANSETRON HYDROCHLORIDE ONDANSETRON HYDROCHLORIDE, ONDANSETRON HYDROCHLORIDE OXYTOCIN, OXYTOCIN PAMIDRONATE DISODIUM, PAMIDRONATE DISODIUM PENICILLIN G POTASSIUM, PENICILLIN G POTASSIUM PENTAM, PENTAMIDINE ISETHIONATE POLOCAINE, MEPIVACAINE HYDROCHLORIDE POLOCAINE-MPF, MEPIVACAINE HYDROCHLORIDE POLYMYXIN B SULFATE, POLYMYXIN B SULFATE POTASSIUM CHLORIDE IN PLASTIC CONTAINER, POTASSIUM CHLORIDE POTASSIUM CHLORIDE, POTASSIUM CHLORIDE PROGESTERONE, PROGESTERONE PROPRANOLOL HYDROCHLORIDE, PROPRANOLOL HYDROCHLORIDE PYRIDOXINE HYDROCHLORIDE, PYRIDOXINE HYDROCHLORIDE ROCURONIUM BROMIDE, ROCURONIUM BROMIDE SENSORCAINE, BUPIVACAINE HYDROCHLORIDE SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, SODIUM CHLORIDE STERILE WATER FOR INJECTION IN PLASTIC CONTAINER, STERILE WATER FOR INJECTION SUMATRIPTAN SUCCINATE, SUMATRIPTAN SUCCINATE TERBUTALINE SULFATE, TERBUTALINE SULFATE THIAMINE HYDROCHLORIDE, THIAMINE HYDROCHLORIDE
THIOTEPA, THIOTEPA

SEPTEMBER 2010 - APPROVED DRUG PRODUCTS LIST

B - 17

APPENDIX B

PRODUCT NAME SORTED BY APPLICANT


** A **

* APP PHARMACEUTICALS LLC TOBRAMYCIN SULFATE (PHARMACY BULK), TOBRAMYCIN SULFATE TOBRAMYCIN SULFATE, TOBRAMYCIN SULFATE VALPROATE SODIUM, VALPROATE SODIUM VANCOMYCIN HYDROCHLORIDE, VANCOMYCIN HYDROCHLORIDE VIBISONE, CYANOCOBALAMIN VINBLASTINE SULFATE, VINBLASTINE SULFATE VINCRISTINE SULFATE, VINCRISTINE SULFATE VINORELBINE TARTRATE, VINORELBINE TARTRATE XYLOCAINE 4% PRESERVATIVE FREE, LIDOCAINE HYDROCHLORIDE XYLOCAINE PRESERVATIVE FREE, LIDOCAINE HYDROCHLORIDE XYLOCAINE VISCOUS, LIDOCAINE HYDROCHLORIDE XYLOCAINE W/ EPINEPHRINE, EPINEPHRINE
XYLOCAINE, LIDOCAINE HYDROCHLORIDE
AR HOLDING CO INC * AR HOLDING CO INC COLCRYS, COLCHICINE FIBRICOR, FENOFIBRIC ACID
QUALAQUIN, QUININE SULFATE
ARMSTRONG PHARMS * ARMSTRONG PHARMACEUTICALS INC EPINEPHRINE, EPINEPHRINE (OTC) ASCEND * ASCEND THERAPEUTICS INC ESTROGEL, ESTRADIOL ASTELLAS * ASTELLAS PHARMA US INC ADENOCARD, ADENOSINE ADENOSCAN, ADENOSINE AMBISOME, AMPHOTERICIN B LEXISCAN, REGADENOSON MYCAMINE, MICAFUNGIN SODIUM PROGRAF, TACROLIMUS PROTOPIC, TACROLIMUS VAPRISOL IN 5% DEXTROSE IN PLASTIC CONTAINER, VESICARE, SOLIFENACIN SUCCINATE ASTRAZENECA * ASTRAZENECA LP ENTOCORT EC, BUDESONIDE FOSCAVIR, FOSCARNET SODIUM MEPERIDINE HYDROCHLORIDE PRESERVATIVE FREE, NEXIUM IV, ESOMEPRAZOLE SODIUM NEXIUM, ESOMEPRAZOLE MAGNESIUM PRILOSEC OTC, OMEPRAZOLE MAGNESIUM (OTC) PRILOSEC, OMEPRAZOLE PRILOSEC, OMEPRAZOLE MAGNESIUM PULMICORT FLEXHALER, BUDESONIDE PULMICORT RESPULES, BUDESONIDE RHINOCORT, BUDESONIDE SEROQUEL, QUETIAPINE FUMARATE SYMBICORT, BUDESONIDE TENORMIN, ATENOLOL
TOPROL-XL, METOPROLOL SUCCINATE
* ASTRAZENECA PHARMACEUTICALS LP ATACAND HCT, CANDESARTAN CILEXETIL ATACAND, CANDESARTAN CILEXETIL FASLODEX, FULVESTRANT PULMICORT, BUDESONIDE SEROQUEL XR, QUETIAPINE FUMARATE TENORETIC 100, ATENOLOL TENORETIC 50, ATENOLOL ZOMIG, ZOLMITRIPTAN
ZOMIG-ZMT, ZOLMITRIPTAN

CONIVAPTAN HYDROCHLORIDE

MEPERIDINE HYDROCHLORIDE

SEPTEMBER 2010 - APPROVED DRUG PRODUCTS LIST

B - 18

APPENDIX B

PRODUCT NAME SORTED BY APPLICANT


** A **

* ASTRAZENECA UK LTD ACCOLATE, ZAFIRLUKAST ARIMIDEX, ANASTROZOLE CASODEX, BICALUTAMIDE IRESSA, GEFITINIB MERREM I.V., MEROPENEM ZESTORETIC, HYDROCHLOROTHIAZIDE ZESTRIL, LISINOPRIL
ZOLADEX, GOSERELIN ACETATE
ATON * ATON PHARMA INC CUPRIMINE, PENICILLAMINE DEMSER, METYROSINE EDECRIN, ETHACRYNATE SODIUM EDECRIN, ETHACRYNIC ACID LACRISERT, HYDROXYPROPYL CELLULOSE MEPHYTON, PHYTONADIONE SYPRINE, TRIENTINE HYDROCHLORIDE TIMOPTIC IN OCUDOSE, TIMOLOL MALEATE TIMOPTIC, TIMOLOL MALEATE
TIMOPTIC-XE, TIMOLOL MALEATE
AUROBINDO * AUROBINDO PHARMA LTD AMOXICILLIN, AMOXICILLIN CITALOPRAM HYDROBROMIDE, CITALOPRAM HYDROBROMIDE LISINOPRIL AND HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE LISINOPRIL, LISINOPRIL METFORMIN HYDROCHLORIDE, METFORMIN HYDROCHLORIDE MIRTAZAPINE, MIRTAZAPINE
ZIDOVUDINE, ZIDOVUDINE
AUROBINDO PHARM * AUROBINDO PHARMA USA INC FLUCONAZOLE, FLUCONAZOLE FLUOXETINE HYDROCHLORIDE, FLUOXETINE HYDROCHLORIDE GABAPENTIN, GABAPENTIN
LEVETIRACETAM, LEVETIRACETAM
AUROBINDO PHARMA * AUROBINDO PHARMA LTD ALENDRONATE SODIUM, ALENDRONATE SODIUM AMLODIPINE BESYLATE, AMLODIPINE BESYLATE AMOXICILLIN, AMOXICILLIN ATENOLOL, ATENOLOL BENAZEPRIL HYDROCHLORIDE, BENAZEPRIL HYDROCHLORIDE BISOPROLOL FUMARATE, BISOPROLOL FUMARATE CARISOPRODOL, CARISOPRODOL CARVEDILOL, CARVEDILOL CEFADROXIL, CEFADROXIL/CEFADROXIL HEMIHYDRATE CEFAZOLIN SODIUM, CEFAZOLIN SODIUM CEFDINIR, CEFDINIR CEFOTAXIME SODIUM, CEFOTAXIME SODIUM CEFPODOXIME PROXETIL, CEFPODOXIME PROXETIL CEFPROZIL, CEFPROZIL CEFTRIAXONE, CEFTRIAXONE SODIUM CETIRIZINE HYDROCHLORIDE, CETIRIZINE HYDROCHLORIDE CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY, CETIRIZINE HYDROCHLORIDE (OTC) CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF, CETIRIZINE HYDROCHLORIDE (OTC) CIPROFLOXACIN HYDROCHLORIDE, CIPROFLOXACIN HYDROCHLORIDE CLINDAMYCIN HYDROCHLORIDE, CLINDAMYCIN HYDROCHLORIDE CYCLOBENZAPRINE HYDROCHLORIDE, CYCLOBENZAPRINE HYDROCHLORIDE DIDANOSINE, DIDANOSINE FINASTERIDE, FINASTERIDE FLUCONAZOLE, FLUCONAZOLE
FLUOXETINE HYDROCHLORIDE, FLUOXETINE HYDROCHLORIDE

SEPTEMBER 2010 - APPROVED DRUG PRODUCTS LIST

B - 19

APPENDIX B

PRODUCT NAME SORTED BY APPLICANT


** A **

* AUROBINDO PHARMA LTD FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE, FOSINOPRIL SODIUM GLYBURIDE AND METFORMIN HYDROCHLORIDE, GLYBURIDE GLYBURIDE, GLYBURIDE HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE LAMOTRIGINE, LAMOTRIGINE LEVETIRACETAM, LEVETIRACETAM MELOXICAM, MELOXICAM METOPROLOL TARTRATE, METOPROLOL TARTRATE MINOCYCLINE HYDROCHLORIDE, MINOCYCLINE HYDROCHLORIDE ONDANSETRON HYDROCHLORIDE, ONDANSETRON HYDROCHLORIDE ONDANSETRON, ONDANSETRON PAROXETINE HYDROCHLORIDE, PAROXETINE HYDROCHLORIDE PENICILLIN V POTASSIUM, PENICILLIN V POTASSIUM PERINDOPRIL ERBUMINE, PERINDOPRIL ERBUMINE QUINAPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE RIBAVARIN, RIBAVIRIN RIBAVIRIN, RIBAVIRIN RISPERIDONE, RISPERIDONE SERTRALINE HYDROCHLORIDE, SERTRALINE HYDROCHLORIDE SIMVASTATIN, SIMVASTATIN STAVUDINE, STAVUDINE SULFAMETHOXAZOLE AND TRIMETHOPRIM, SULFAMETHOXAZOLE SUMATRIPTAN SUCCINATE, SUMATRIPTAN SUCCINATE TERBINAFINE HYDROCHLORIDE, TERBINAFINE HYDROCHLORIDE TOPIRAMATE, TOPIRAMATE TORSEMIDE, TORSEMIDE TRANDOLAPRIL, TRANDOLAPRIL VENLAFAXINE HYDROCHLORIDE, VENLAFAXINE HYDROCHLORIDE ZALEPLON, ZALEPLON
ZOLPIDEM TARTRATE, ZOLPIDEM TARTRATE
AUROBINDO PHARMA LTD * AUROBINDO PHARMA LTD INC CEFPROZIL, CEFPROZIL CEFUROXIME AXETIL, CEFUROXIME AXETIL CEPHALEXIN, CEPHALEXIN CITALOPRAM HYDROBROMIDE, CITALOPRAM HYDROBROMIDE MIRTAZAPINE, MIRTAZAPINE
ZIDOVUDINE, ZIDOVUDINE
AUROSAL PHARMS * AUROSAL PHARMACEUTICALS LLC AMIODARONE HYDROCHLORIDE,

AMIODARONE HYDROCHLORIDE

AUSTARPHARMA LLC * AUSTARPHARMA LLC ALENDRONATE SODIUM, ALENDRONATE SODIUM


SERTRALINE HYDROCHLORIDE, SERTRALINE HYDROCHLORIDE
AUXILIUM PHARMS * AUXILIUM PHARMACEUTICALS TESTIM, TESTOSTERONE AVANTHI INC * AVANTHI INC CHLORPHENIRAMINE MALEATE, CHLORPHENIRAMINE MALEATE INDOMETHACIN, INDOMETHACIN
OXYCODONE HYDROCHLORIDE, OXYCODONE HYDROCHLORIDE
AVENT * AVENT INC PYTEST KIT, UREA, C-14
PYTEST, UREA, C-14
AVEVA * AVEVA DRUG DELIVERY SYSTEMS INC CLONIDINE, CLONIDINE
NICOTINE, NICOTINE (OTC)

(OTC)

SEPTEMBER 2010 - APPROVED DRUG PRODUCTS LIST

B - 20

APPENDIX B

PRODUCT NAME SORTED BY APPLICANT

** A **

AXCAN * AXCAN PHARMA US INC BENTYL PRESERVATIVE FREE, DICYCLOMINE HYDROCHLORIDE BENTYL, DICYCLOMINE HYDROCHLORIDE CARAFATE, SUCRALFATE PHOTOFRIN, PORFIMER SODIUM URSO 250, URSODIOL URSO FORTE, URSODIOL AXCAN SCANDIPHARM * AXCAN SCANDIPHARM INC CANASA, MESALAMINE PYLERA, BISMUTH SUBCITRATE POTASSIUM AZUR PHARMA * AZUR PHARMA INTERNATIONAL LTD AVC, SULFANILAMIDE GASTROCROM, CROMOLYN SODIUM AZUR PHARMA II * AZUR PHARMA INTERNATIONAL II LTD ELESTRIN, ESTRADIOL AZUR PHARMA INTL * AZUR PHARMA INTERNATIONAL III LTD FAZACLO ODT, CLOZAPINE B BRAUN * B BRAUN MEDICAL INC ACETIC ACID 0.25% IN PLASTIC CONTAINER, ACETIC ACID, GLACIAL ALCOHOL 10% AND DEXTROSE 5%, ALCOHOL ALCOHOL 5% AND DEXTROSE 5%, ALCOHOL BALANCED SALT, CALCIUM CHLORIDE BRETYLIUM TOSYLATE IN DEXTROSE 5% IN PLASTIC CONTAINER, BRETYLIUM TOSYLATE CEFAZOLIN AND DEXTROSE, CEFAZOLIN SODIUM CEFOTETAN AND DEXTROSE IN DUPLEX CONTAINER, CEFOTETAN DISODIUM CEFOXITIN AND DEXTROSE IN DUPLEX CONTAINER, CEFOXITIN SODIUM CEFTRIAXONE AND DEXTROSE IN DUPLEX CONTAINER, CEFTRIAXONE SODIUM CEFUROXIME AND DEXTROSE IN DUPLEX CONTAINER, CEFUROXIME SODIUM DEXTROSE 10% AND SODIUM CHLORIDE 0.11% IN PLASTIC CONTAINER, DEXTROSE DEXTROSE 10% AND SODIUM CHLORIDE 0.2% IN PLASTIC CONTAINER, DEXTROSE DEXTROSE 10% AND SODIUM CHLORIDE 0.33% IN PLASTIC CONTAINER, DEXTROSE DEXTROSE 10% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER, DEXTROSE DEXTROSE 10% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, DEXTROSE DEXTROSE 10% IN PLASTIC CONTAINER, DEXTROSE DEXTROSE 2.5% AND SODIUM CHLORIDE 0.11% IN PLASTIC CONTAINER, DEXTROSE DEXTROSE 2.5% AND SODIUM CHLORIDE 0.2% IN PLASTIC CONTAINER, DEXTROSE DEXTROSE 2.5% AND SODIUM CHLORIDE 0.33% IN PLASTIC CONTAINER, DEXTROSE DEXTROSE 2.5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER, DEXTROSE DEXTROSE 2.5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, DEXTROSE DEXTROSE 2.5% IN HALF-STRENGTH LACTATED RINGER'S IN PLASTIC CONTAINER, CALCIUM CHLORIDE DEXTROSE 3.3% AND SODIUM CHLORIDE 0.3% IN PLASTIC CONTAINER, DEXTROSE DEXTROSE 5% AND SODIUM CHLORIDE 0.11% IN PLASTIC CONTAINER, DEXTROSE DEXTROSE 5% AND SODIUM CHLORIDE 0.2% IN PLASTIC CONTAINER, DEXTROSE DEXTROSE 5% AND SODIUM CHLORIDE 0.33% IN PLASTIC CONTAINER, DEXTROSE DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER, DEXTROSE DEXTROSE 5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, DEXTROSE DEXTROSE 5% IN ACETATED RINGER'S IN PLASTIC CONTAINER, CALCIUM CHLORIDE DEXTROSE 5% IN LACTATED RINGER'S IN PLASTIC CONTAINER, CALCIUM CHLORIDE DEXTROSE 5% IN PLASTIC CONTAINER, DEXTROSE DEXTROSE 5% IN RINGER'S IN PLASTIC CONTAINER, CALCIUM CHLORIDE DIALYTE CONCENTRATE W/ DEXTROSE 30% IN PLASTIC CONTAINER, CALCIUM CHLORIDE DIALYTE CONCENTRATE W/ DEXTROSE 50% IN PLASTIC CONTAINER, CALCIUM CHLORIDE DIALYTE LM/ DEXTROSE 1.5% IN PLASTIC CONTAINER, CALCIUM CHLORIDE DIALYTE LM/ DEXTROSE 2.5% IN PLASTIC CONTAINER, CALCIUM CHLORIDE DIALYTE LM/ DEXTROSE 4.25% IN PLASTIC CONTAINER, CALCIUM CHLORIDE DOPAMINE HYDROCHLORIDE AND DEXTROSE 5% IN PLASTIC CONTAINER, DOPAMINE HYDROCHLORIDE

SEPTEMBER 2010 - APPROVED DRUG PRODUCTS LIST

B - 21

APPENDIX B

PRODUCT NAME SORTED BY APPLICANT


** B **

* B BRAUN MEDICAL INC DOPAMINE HYDROCHLORIDE AND DEXTROSE 5%, DOPAMINE HYDROCHLORIDE FREAMINE HBC 6.9%, AMINO ACIDS FREAMINE III 10%, AMINO ACIDS FREAMINE III 3% W/ ELECTROLYTES, AMINO ACIDS FREAMINE III 8.5% W/ ELECTROLYTES, AMINO ACIDS FREAMINE III 8.5%, AMINO ACIDS GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, GENTAMICIN SULFATE GLYCINE 1.5% IN PLASTIC CONTAINER, GLYCINE HEPARIN SODIUM 1,000 UNITS IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, HEPARIN SODIUM HEPARIN SODIUM 20,000 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINER, HEPARIN SODIUM HEPARIN SODIUM 25,000 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINER, HEPARIN SODIUM HEPATAMINE 8%, AMINO ACIDS ISOLYTE E IN DEXTROSE 5% IN PLASTIC CONTAINER, CALCIUM CHLORIDE ISOLYTE E IN PLASTIC CONTAINER, CALCIUM CHLORIDE ISOLYTE H IN DEXTROSE 5% IN PLASTIC CONTAINER, DEXTROSE ISOLYTE M IN DEXTROSE 5% IN PLASTIC CONTAINER, DEXTROSE ISOLYTE P IN DEXTROSE 5% IN PLASTIC CONTAINER, DEXTROSE ISOLYTE R IN DEXTROSE 5% IN PLASTIC CONTAINER, CALCIUM CHLORIDE ISOLYTE S IN DEXTROSE 5% IN PLASTIC CONTAINER, DEXTROSE ISOLYTE S IN PLASTIC CONTAINER, MAGNESIUM CHLORIDE ISOLYTE S PH 7.4 IN PLASTIC CONTAINER, MAGNESIUM CHLORIDE LACTATED RINGER'S IN PLASTIC CONTAINER, CALCIUM CHLORIDE LIDOCAINE HYDROCHLORIDE 0.2% AND DEXTROSE 5% IN PLASTIC CONTAINER, LIDOCAINE HYDROCHLORIDE LIDOCAINE HYDROCHLORIDE 0.4% AND DEXTROSE 5% IN PLASTIC CONTAINER, LIDOCAINE HYDROCHLORIDE LIDOCAINE HYDROCHLORIDE 0.8% AND DEXTROSE 5% IN PLASTIC CONTAINER, LIDOCAINE HYDROCHLORIDE MANNITOL 10% IN PLASTIC CONTAINER, MANNITOL MANNITOL 10% W/ DEXTROSE 5% IN DISTILLED WATER, MANNITOL MANNITOL 10%, MANNITOL MANNITOL 15% IN PLASTIC CONTAINER, MANNITOL MANNITOL 15% W/ DEXTROSE 5% IN SODIUM CHLORIDE 0.45%, MANNITOL MANNITOL 15%, MANNITOL MANNITOL 20% IN PLASTIC CONTAINER, MANNITOL MANNITOL 20%, MANNITOL MANNITOL 5% IN PLASTIC CONTAINER, MANNITOL MANNITOL 5% W/ DEXTROSE 5% IN SODIUM CHLORIDE 0.12%, MANNITOL MANNITOL 5%, MANNITOL METRO I.V. IN PLASTIC CONTAINER, METRONIDAZOLE MILRINONE LACTATE IN DEXTROSE 5% IN PLASTIC CONTAINER, MILRINONE LACTATE NEPHRAMINE 5.4%, AMINO ACIDS NUTRILIPID 10%, SOYBEAN OIL NUTRILIPID 20%, SOYBEAN OIL PHYSIOLYTE IN PLASTIC CONTAINER, MAGNESIUM CHLORIDE POTASSIUM CHLORIDE 0.037% IN DEXTROSE 10% AND SODIUM CHLORIDE 0.2% IN PLASTIC CONTAINER, DEXTROSE POTASSIUM CHLORIDE 0.037% IN DEXTROSE 10% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER, DEXTROSE POTASSIUM CHLORIDE 0.037% IN DEXTROSE 10% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, DEXTROSE POTASSIUM CHLORIDE 0.037% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.11% IN PLASTIC CONTAINER, DEXTROSE POTASSIUM CHLORIDE 0.037% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.2% IN PLASTIC CONTAINER, DEXTROSE POTASSIUM CHLORIDE 0.037% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.33% IN PLASTIC CONTAINER, DEXTROSE POTASSIUM CHLORIDE 0.037% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER, DEXTROSE POTASSIUM CHLORIDE 0.037% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, DEXTROSE POTASSIUM CHLORIDE 0.075% IN DEXTROSE 10% AND SODIUM CHLORIDE 0.2% IN PLASTIC CONTAINER, DEXTROSE
POTASSIUM CHLORIDE 0.075% IN DEXTROSE 10% AND SODIUM CHLORIDE 0.45% IN PLASTIC
CONTAINER, DEXTROSE

SEPTEMBER 2010 - APPROVED DRUG PRODUCTS LIST

B - 22

APPENDIX B

PRODUCT NAME SORTED BY APPLICANT


** B **

* B BRAUN MEDICAL INC POTASSIUM CHLORIDE 0.075% IN DEXTROSE 10% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, DEXTROSE POTASSIUM CHLORIDE 0.075% IN DEXTROSE 3.3% AND SODIUM CHLORIDE 0.3% IN PLASTIC
CONTAINER, DEXTROSE
POTASSIUM CHLORIDE 0.075% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.11% IN PLASTIC CONTAINER,
DEXTROSE
POTASSIUM CHLORIDE 0.075% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.2% IN PLASTIC CONTAINER,
DEXTROSE
POTASSIUM CHLORIDE 0.075% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.33% IN PLASTIC CONTAINER,
DEXTROSE
POTASSIUM CHLORIDE 0.075% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER,
DEXTROSE
POTASSIUM CHLORIDE 0.075% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER,
DEXTROSE
POTASSIUM CHLORIDE 0.075% IN DEXTROSE 5% IN PLASTIC CONTAINER, DEXTROSE
POTASSIUM CHLORIDE 0.11% IN DEXTROSE 10% AND SODIUM CHLORIDE 0.2% IN PLASTIC CONTAINER,
DEXTROSE
POTASSIUM CHLORIDE 0.11% IN DEXTROSE 10% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER,
DEXTROSE
POTASSIUM CHLORIDE 0.11% IN DEXTROSE 10% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER,
DEXTROSE
POTASSIUM CHLORIDE 0.11% IN DEXTROSE 3.3% AND SODIUM CHLORIDE 0.3% IN PLASTIC CONTAINER,
DEXTROSE
POTASSIUM CHLORIDE 0.11% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.11% IN PLASTIC CONTAINER,
DEXTROSE
POTASSIUM CHLORIDE 0.11% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.2% IN PLASTIC CONTAINER,
DEXTROSE
POTASSIUM CHLORIDE 0.11% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.33% IN PLASTIC CONTAINER,
DEXTROSE
POTASSIUM CHLORIDE 0.11% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER,
DEXTROSE
POTASSIUM CHLORIDE 0.11% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER,
DEXTROSE
POTASSIUM CHLORIDE 0.15% IN DEXTROSE 10% AND SODIUM CHLORIDE 0.2% IN PLASTIC CONTAINER,
DEXTROSE
POTASSIUM CHLORIDE 0.15% IN DEXTROSE 10% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER,
DEXTROSE
POTASSIUM CHLORIDE 0.15% IN DEXTROSE 10% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER,
DEXTROSE
POTASSIUM CHLORIDE 0.15% IN DEXTROSE 3.3% AND SODIUM CHLORIDE 0.3% IN PLASTIC CONTAINER,
DEXTROSE
POTASSIUM CHLORIDE 0.15% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.11% IN PLASTIC CONTAINER,
DEXTROSE
POTASSIUM CHLORIDE 0.15% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.2% IN PLASTIC CONTAINER,
DEXTROSE
POTASSIUM CHLORIDE 0.15% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.33% IN PLASTIC CONTAINER,
DEXTROSE
POTASSIUM CHLORIDE 0.15% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER,
DEXTROSE
POTASSIUM CHLORIDE 0.15% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER,
DEXTROSE
POTASSIUM CHLORIDE 0.15% IN DEXTROSE 5% IN PLASTIC CONTAINER, DEXTROSE
POTASSIUM CHLORIDE 0.15% IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, POTASSIUM CHLORIDE
POTASSIUM CHLORIDE 0.22% IN DEXTROSE 10% AND SODIUM CHLORIDE 0.2% IN PLASTIC CONTAINER,
DEXTROSE
POTASSIUM CHLORIDE 0.22% IN DEXTROSE 10% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER,
DEXTROSE
POTASSIUM CHLORIDE 0.22% IN DEXTROSE 10% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER,
DEXTROSE
POTASSIUM CHLORIDE 0.22% IN DEXTROSE 3.3% AND SODIUM CHLORIDE 0.3% IN PLASTIC CONTAINER,
DEXTROSE
POTASSIUM CHLORIDE 0.22% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.11% IN PLASTIC CONTAINER,
DEXTROSE
POTASSIUM CHLORIDE 0.22% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.2% IN PLASTIC CONTAINER,
DEXTROSE
POTASSIUM CHLORIDE 0.22% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.33% IN PLASTIC CONTAINER,
DEXTROSE POTASSIUM CHLORIDE 0.22% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER, DEXTROSE

SEPTEMBER 2010 - APPROVED DRUG PRODUCTS LIST

B - 23

APPENDIX B

PRODUCT NAME SORTED BY APPLICANT


** B **

* B BRAUN MEDICAL INC POTASSIUM CHLORIDE 0.22% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, DEXTROSE POTASSIUM CHLORIDE 0.22% IN DEXTROSE 5% IN PLASTIC CONTAINER, DEXTROSE
POTASSIUM CHLORIDE 0.3% IN DEXTROSE 10% AND SODIUM CHLORIDE 0.2% IN PLASTIC CONTAINER, DEXTROSE
POTASSIUM CHLORIDE 0.3% IN DEXTROSE 10% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER, DEXTROSE
POTASSIUM CHLORIDE 0.3% IN DEXTROSE 10% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, DEXTROSE
POTASSIUM CHLORIDE 0.3% IN DEXTROSE 3.3% AND SODIUM CHLORIDE 0.3% IN PLASTIC CONTAINER, DEXTROSE
POTASSIUM CHLORIDE 0.3% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.11% IN PLASTIC CONTAINER, DEXTROSE
POTASSIUM CHLORIDE 0.3% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.2% IN PLASTIC CONTAINER,
DEXTROSE
POTASSIUM CHLORIDE 0.3% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.33% IN PLASTIC CONTAINER, DEXTROSE
POTASSIUM CHLORIDE 0.3% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER, DEXTROSE
POTASSIUM CHLORIDE 0.3% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, DEXTROSE POTASSIUM CHLORIDE 0.3% IN DEXTROSE 5% IN PLASTIC CONTAINER, DEXTROSE POTASSIUM CHLORIDE, POTASSIUM CHLORIDE PROCALAMINE, AMINO ACIDS RESECTISOL IN PLASTIC CONTAINER, MANNITOL RINGER'S IN PLASTIC CONTAINER, CALCIUM CHLORIDE SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER, SODIUM CHLORIDE SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, SODIUM CHLORIDE SODIUM LACTATE 1/6 MOLAR IN PLASTIC CONTAINER, SODIUM LACTATE SORBITOL 3.3% IN PLASTIC CONTAINER, SORBITOL STERILE WATER FOR INJECTION IN PLASTIC CONTAINER, STERILE WATER FOR INJECTION STERILE WATER IN PLASTIC CONTAINER, STERILE WATER FOR IRRIGATION THEOPHYLLINE 0.04% AND DEXTROSE 5% IN PLASTIC CONTAINER, THEOPHYLLINE THEOPHYLLINE 0.08% AND DEXTROSE 5% IN PLASTIC CONTAINER, THEOPHYLLINE THEOPHYLLINE 0.16% AND DEXTROSE 5% IN PLASTIC CONTAINER, THEOPHYLLINE THEOPHYLLINE 0.32% AND DEXTROSE 5% IN PLASTIC CONTAINER, THEOPHYLLINE TROPHAMINE 10%, AMINO ACIDS TROPHAMINE, AMINO ACIDS BANNER PHARMACAPS * BANNER PHARMACAPS INC AMANTADINE HYDROCHLORIDE, AMANTADINE HYDROCHLORIDE BENZONATATE, BENZONATATE CETIRIZINE HYDROCHLORIDE ALLERGY, CETIRIZINE HYDROCHLORIDE (OTC) CETIRIZINE HYDROCHLORIDE HIVES, CETIRIZINE HYDROCHLORIDE (OTC) ETHOSUXIMIDE, ETHOSUXIMIDE IBUPROFEN, IBUPROFEN (OTC) LOPERAMIDE HYDROCHLORIDE, LOPERAMIDE HYDROCHLORIDE (OTC) MIDOL LIQUID GELS, IBUPROFEN (OTC) NAPROXEN SODIUM, NAPROXEN SODIUM (OTC) NIMODIPINE, NIMODIPINE STAVZOR, VALPROIC ACID VALPROIC ACID, VALPROIC ACID VITAMIN D, ERGOCALCIFEROL
ZONISAMIDE, ZONISAMIDE
BARR * BARR LABORATORIES INC ALENDRONATE SODIUM, ALENDRONATE SODIUM ALPRAZOLAM, ALPRAZOLAM AMILORIDE HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE, AMILORIDE HYDROCHLORIDE AMIODARONE HYDROCHLORIDE, AMIODARONE HYDROCHLORIDE ANAGRELIDE HYDROCHLORIDE, ANAGRELIDE HYDROCHLORIDE ARANELLE, ETHINYL ESTRADIOL ASPIRIN AND DIPYRIDAMOLE, ASPIRIN BALZIVA-28, ETHINYL ESTRADIOL
CAMILA, NORETHINDRONE

SEPTEMBER 2010 - APPROVED DRUG PRODUCTS LIST

B - 24

APPENDIX B

PRODUCT NAME SORTED BY APPLICANT


** B **

* BARR LABORATORIES INC CHLORDIAZEPOXIDE HYDROCHLORIDE, CHLORDIAZEPOXIDE HYDROCHLORIDE CHLORZOXAZONE, CHLORZOXAZONE CLARAVIS, ISOTRETINOIN CLONAZEPAM, CLONAZEPAM DANAZOL, DANAZOL DEMECLOCYCLINE HYDROCHLORIDE, DEMECLOCYCLINE HYDROCHLORIDE DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE, AMPHETAMINE ASPARTATE DEXTROAMPHETAMINE SULFATE, DEXTROAMPHETAMINE SULFATE DIAZEPAM, DIAZEPAM DIDANOSINE, DIDANOSINE DIPHENHYDRAMINE HYDROCHLORIDE, DIPHENHYDRAMINE HYDROCHLORIDE DIPYRIDAMOLE, DIPYRIDAMOLE DROSPIRENONE AND ETHINYL ESTRADIOL, DROSPIRENONE ERRIN, NORETHINDRONE ERYTHROMYCIN ETHYLSUCCINATE AND SULFISOXAZOLE ACETYL, ERYTHROMYCIN ETHYLSUCCINATE ESTRADIOL AND NORGESTIMATE, ESTRADIOL ESTRADIOL, ESTRADIOL ESTROPIPATE, ESTROPIPATE ETHAMBUTOL HYDROCHLORIDE, ETHAMBUTOL HYDROCHLORIDE FENTANYL CITRATE, FENTANYL CITRATE FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE, FEXOFENADINE HYDROCHLORIDE FEXOFENADINE HYDROCHLORIDE, FEXOFENADINE HYDROCHLORIDE FLECAINIDE ACETATE, FLECAINIDE ACETATE FLUDROCORTISONE ACETATE, FLUDROCORTISONE ACETATE FLUOXETINE HYDROCHLORIDE, FLUOXETINE HYDROCHLORIDE FLUVOXAMINE MALEATE, FLUVOXAMINE MALEATE GALANTAMINE HYDROBROMIDE, GALANTAMINE HYDROBROMIDE GRANISETRON HYDROCHLORIDE, GRANISETRON HYDROCHLORIDE HYDROMORPHONE HYDROCHLORIDE, HYDROMORPHONE HYDROCHLORIDE HYDROXYUREA, HYDROXYUREA HYDROXYZINE PAMOATE, HYDROXYZINE PAMOATE ISONIAZID, ISONIAZID JUNEL 1.5/30, ETHINYL ESTRADIOL JUNEL 1/20, ETHINYL ESTRADIOL JUNEL FE 1.5/30, ETHINYL ESTRADIOL JUNEL FE 1/20, ETHINYL ESTRADIOL KARIVA, DESOGESTREL KELNOR, ETHINYL ESTRADIOL LEFLUNOMIDE, LEFLUNOMIDE LESSINA-28, ETHINYL ESTRADIOL MEDROXYPROGESTERONE ACETATE, MEDROXYPROGESTERONE ACETATE MEFLOQUINE HYDROCHLORIDE, MEFLOQUINE HYDROCHLORIDE MEGESTROL ACETATE, MEGESTROL ACETATE MEPERIDINE HYDROCHLORIDE, MEPERIDINE HYDROCHLORIDE METFORMIN HYDROCHLORIDE, METFORMIN HYDROCHLORIDE METHOTREXATE SODIUM, METHOTREXATE SODIUM MINOCYCLINE HYDROCHLORIDE, MINOCYCLINE HYDROCHLORIDE NALTREXONE HYDROCHLORIDE, NALTREXONE HYDROCHLORIDE NICARDIPINE HYDROCHLORIDE, NICARDIPINE HYDROCHLORIDE NIMODIPINE, NIMODIPINE NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL, ETHINYL ESTRADIOL NORETHINDRONE ACETATE, NORETHINDRONE ACETATE NORTREL 0.5/35-28, ETHINYL ESTRADIOL NORTREL 1/35-21, ETHINYL ESTRADIOL NORTREL 1/35-28, ETHINYL ESTRADIOL NORTREL 7/7/7, ETHINYL ESTRADIOL ONDANSETRON, ONDANSETRON OXYCODONE HYDROCHLORIDE AND IBUPROFEN, IBUPROFEN PHENTERMINE HYDROCHLORIDE, PHENTERMINE HYDROCHLORIDE PORTIA-28, ETHINYL ESTRADIOL PRAMIPEXOLE DIHYDROCHLORIDE, PRAMIPEXOLE DIHYDROCHLORIDE SPRINTEC, ETHINYL ESTRADIOL TEMOZOLOMIDE, TEMOZOLOMIDE

SEPTEMBER 2010 - APPROVED DRUG PRODUCTS LIST

B - 25

APPENDIX B

PRODUCT NAME SORTED BY APPLICANT


** B **

* BARR LABORATORIES INC TRETINOIN, TRETINOIN TREXALL, METHOTREXATE SODIUM TRI LO SPRINTEC, ETHINYL ESTRADIOL TRIAMCINOLONE ACETONIDE, TRIAMCINOLONE ACETONIDE TRI-LEGEST 21, ETHINYL ESTRADIOL TRI-LEGEST FE, ETHINYL ESTRADIOL TRI-SPRINTEC, ETHINYL ESTRADIOL WARFARIN SODIUM, WARFARIN SODIUM
ZONISAMIDE, ZONISAMIDE
* BARR PHARMACEUTICALS LEUCOVORIN CALCIUM, LEUCOVORIN CALCIUM BAUSCH AND LOMB * BAUSCH AND LOMB INC ALAWAY, KETOTIFEN FUMARATE (OTC) ALBUTEROL SULFATE, ALBUTEROL SULFATE ALREX, LOTEPREDNOL ETABONATE BESIVANCE, BESIFLOXACIN HYDROCHLORIDE CARTEOLOL HYDROCHLORIDE, CARTEOLOL HYDROCHLORIDE DICLOFENAC SODIUM, DICLOFENAC SODIUM DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE, DORZOLAMIDE HYDROCHLORIDE DORZOLAMIDE HYDROCHLORIDE, DORZOLAMIDE HYDROCHLORIDE FLURBIPROFEN SODIUM, FLURBIPROFEN SODIUM IPRATROPIUM BROMIDE, IPRATROPIUM BROMIDE LOTEMAX, LOTEPREDNOL ETABONATE OFLOXACIN, OFLOXACIN OPCON-A, NAPHAZOLINE HYDROCHLORIDE (OTC) RETISERT, FLUOCINOLONE ACETONIDE TIMOLOL MALEATE, TIMOLOL MALEATE VITRASERT, GANCICLOVIR
ZYLET, LOTEPREDNOL ETABONATE
* BAUSCH AND LOMB PHARMACEUTICALS INC ACETIC ACID 2% IN AQUEOUS ALUMINUM ACETATE, ACETIC ACID, GLACIAL BACITRACIN ZINC AND POLYMYXIN B SULFATE, BACITRACIN ZINC BETAXOLOL HYDROCHLORIDE, BETAXOLOL HYDROCHLORIDE BRIMONIDINE TARTRATE, BRIMONIDINE TARTRATE CIPROFLOXACIN HYDROCHLORIDE, CIPROFLOXACIN HYDROCHLORIDE CROLOM, CROMOLYN SODIUM CROMOLYN SODIUM, CROMOLYN SODIUM CROMOLYN SODIUM, CROMOLYN SODIUM (OTC) DESMOPRESSIN ACETATE, DESMOPRESSIN ACETATE DEXAMETHASONE SODIUM PHOSPHATE, DEXAMETHASONE SODIUM PHOSPHATE DEXASPORIN, DEXAMETHASONE DIPIVEFRIN HYDROCHLORIDE, DIPIVEFRIN HYDROCHLORIDE ERYTHROMYCIN, ERYTHROMYCIN FLUNISOLIDE, FLUNISOLIDE GENTAMICIN SULFATE, GENTAMICIN SULFATE IPRATROPIUM BROMIDE, IPRATROPIUM BROMIDE LEVOBUNOLOL HYDROCHLORIDE, LEVOBUNOLOL HYDROCHLORIDE MINOXIDIL (FOR MEN), MINOXIDIL (OTC) NAFAZAIR, NAPHAZOLINE HYDROCHLORIDE NEOMYCIN AND POLYMYXIN B SULFATES AND BACITRACIN ZINC, BACITRACIN ZINC NEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONE, DEXAMETHASONE NEOMYCIN AND POLYMYXIN B SULFATES AND GRAMICIDIN, GRAMICIDIN NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE, HYDROCORTISONE NEOMYCIN AND POLYMYXIN B SULFATES, BACITRACIN ZINC AND HYDROCORTISONE, BACITRACIN ZINC NYSTATIN, NYSTATIN OFLOXACIN, OFLOXACIN OPTIPRANOLOL, METIPRANOLOL HYDROCHLORIDE OTICAIR, HYDROCORTISONE PENTOLAIR, CYCLOPENTOLATE HYDROCHLORIDE PREDNISOLONE SODIUM PHOSPHATE, PREDNISOLONE SODIUM PHOSPHATE PROPARACAINE HYDROCHLORIDE, PROPARACAINE HYDROCHLORIDE SULFACETAMIDE SODIUM AND PREDNISOLONE SODIUM PHOSPHATE, PREDNISOLONE SODIUM PHOSPHATE SULFACETAMIDE SODIUM, SULFACETAMIDE SODIUM

SEPTEMBER 2010 - APPROVED DRUG PRODUCTS LIST

B - 26

APPENDIX B

PRODUCT NAME SORTED BY APPLICANT


** B **

* BAUSCH AND LOMB PHARMACEUTICALS INC TIMOLOL MALEATE, TIMOLOL MALEATE TOBRAMYCIN AND DEXAMETHASONE, DEXAMETHASONE TOBRAMYCIN, TOBRAMYCIN TRIMETHOPRIM SULFATE AND POLYMYXIN B SULFATE, TROPICAMIDE, TROPICAMIDE

POLYMYXIN B SULFATE

BAXTER HLTHCARE * BAXTER HEALTHCARE CORP ACETIC ACID 0.25% IN PLASTIC CONTAINER, ACETIC ACID, GLACIAL ADENOSINE, ADENOSINE AMINOACETIC ACID 1.5% IN PLASTIC CONTAINER, GLYCINE ANCEF IN PLASTIC CONTAINER, CEFAZOLIN SODIUM BACTOCILL IN PLASTIC CONTAINER, OXACILLIN SODIUM BRANCHAMIN 4% IN PLASTIC CONTAINER, AMINO ACIDS CARDIOPLEGIC IN PLASTIC CONTAINER, CALCIUM CHLORIDE CEFEPIME IN PLASTIC CONTAINER, CEFEPIME HYDROCHLORIDE CEFTRIAXONE IN PLASTIC CONTAINER, CEFTRIAXONE SODIUM CIPROFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER, CIPROFLOXACIN CLINIMIX 2.75/10 SULFITE FREE IN DEXTROSE 10% IN PLASTIC CONTAINER, AMINO ACIDS CLINIMIX 2.75/25 SULFITE FREE IN DEXTROSE 25% IN PLASTIC CONTAINER, AMINO ACIDS CLINIMIX 2.75/5 SULFITE FREE IN DEXTROSE 5% IN PLASTIC CONTAINER, AMINO ACIDS CLINIMIX 4.25/10 SULFITE FREE IN DEXTROSE 10% IN PLASTIC CONTAINER, AMINO ACIDS CLINIMIX 4.25/20 SULFITE FREE IN DEXTROSE 20% IN PLASTIC CONTAINER, AMINO ACIDS CLINIMIX 4.25/25 SULFITE FREE IN DEXTROSE 25% IN PLASTIC CONTAINER, AMINO ACIDS CLINIMIX 4.25/5 SULFITE FREE IN DEXTROSE 5% IN PLASTIC CONTAINER, AMINO ACIDS CLINIMIX 5/10 SULFITE FREE IN DEXTROSE 10% IN PLASTIC CONTAINER, AMINO ACIDS CLINIMIX 5/15 SULFITE FREE IN DEXTROSE 15% IN PLASTIC CONTAINER, AMINO ACIDS CLINIMIX 5/20 SULFITE FREE IN DEXTROSE 20% IN PLASTIC CONTAINER, AMINO ACIDS CLINIMIX 5/25 SULFITE FREE IN DEXTROSE 25% IN PLASTIC CONTAINER, AMINO ACIDS CLINIMIX 5/35 SULFITE FREE IN DEXTROSE 35% IN PLASTIC CONTAINER, AMINO ACIDS CLINIMIX E 2.75/10 SULFITE-FREE W/ ELECT IN DEXTROSE 10% W/ CALCIUM IN PLASTIC CONTAINER, AMINO ACIDS CLINIMIX E 2.75/25 SULFITE-FREE W/ ELECT IN DEXTROSE 25% W/ CALCIUM IN PLASTIC CONTAINER, AMINO ACIDS CLINIMIX E 2.75/5 SULFITE-FREE W/ ELECT IN DEXTROSE 5% W/ CALCIUM IN PLASTIC CONTAINER, AMINO ACIDS CLINIMIX E 4.25/10 SULFITE-FREE W/ ELECT IN DEXTROSE 10% W/ CALCIUM IN PLASTIC CONTAINER, AMINO ACIDS CLINIMIX E 4.25/20 SULFITE-FREE W/ ELECT IN DEXTROSE 20% W/ CALCIUM IN PLASTIC CONTAINER, AMINO ACIDS CLINIMIX E 4.25/25 SULFITE-FREE W/ ELECT IN DEXTROSE 25% W/ CALCIUM IN PLASTIC CONTAINER, AMINO ACIDS CLINIMIX E 4.25/5 SULFITE-FREE W/ ELECT IN DEXTROSE 5% W/ CALCIUM IN PLASTIC CONTAINER, AMINO ACIDS CLINIMIX E 5/10 SULFITE-FREE W/ ELECT IN DEXTROSE 10% W/ CALCIUM IN PLASTIC CONTAINER, AMINO ACIDS CLINIMIX E 5/15 SULFITE-FREE W/ ELECT IN DEXTROSE 15% W/ CALCIUM IN PLASTIC CONTAINER, AMINO ACIDS CLINIMIX E 5/20 SULFITE-FREE W/ ELECT IN 20% DEXTROSE W/ CALCIUM IN PLASTIC CONTAINER, AMINO ACIDS CLINIMIX E 5/25 SULFITE-FREE W/ ELECT IN DEXTROSE 25% W/ CALCIUM IN PLASTIC CONTAINER, AMINO ACIDS CLINIMIX E 5/35 SULFITE-FREE W/ ELECT IN DEXTROSE 35% W/ CALCIUM IN PLASTIC CONTAINER, AMINO ACIDS CYTOXAN, CYCLOPHOSPHAMIDE DEXTROSE 10% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, DEXTROSE DEXTROSE 10% IN PLASTIC CONTAINER, DEXTROSE DEXTROSE 2.5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER, DEXTROSE DEXTROSE 20% IN PLASTIC CONTAINER, DEXTROSE DEXTROSE 30% IN PLASTIC CONTAINER, DEXTROSE DEXTROSE 40% IN PLASTIC CONTAINER, DEXTROSE DEXTROSE 5% AND ELECTROLYTE NO 75 IN PLASTIC CONTAINER, DEXTROSE DEXTROSE 5% AND ELECTROLYTE NO.48 IN PLASTIC CONTAINER, DEXTROSE DEXTROSE 5% IN PLASTIC CONTAINER, DEXTROSE DEXTROSE 5% IN RINGER'S IN PLASTIC CONTAINER, CALCIUM CHLORIDE DEXTROSE 5% IN SODIUM CHLORIDE 0.2% IN PLASTIC CONTAINER, DEXTROSE

SEPTEMBER 2010 - APPROVED DRUG PRODUCTS LIST

B - 27

APPENDIX B

PRODUCT NAME SORTED BY APPLICANT


** B **

* BAXTER HEALTHCARE CORP DEXTROSE 5% IN SODIUM CHLORIDE 0.33% IN PLASTIC CONTAINER, DEXTROSE DEXTROSE 5% IN SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER, DEXTROSE DEXTROSE 5% IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, DEXTROSE DEXTROSE 5%, SODIUM CHLORIDE 0.2% AND POTASSIUM CHLORIDE 10MEQ, DEXTROSE DEXTROSE 5%, SODIUM CHLORIDE 0.2% AND POTASSIUM CHLORIDE 15MEQ (K), DEXTROSE DEXTROSE 5%, SODIUM CHLORIDE 0.2% AND POTASSIUM CHLORIDE 20MEQ (K), DEXTROSE DEXTROSE 5%, SODIUM CHLORIDE 0.2% AND POTASSIUM CHLORIDE 20MEQ, DEXTROSE DEXTROSE 5%, SODIUM CHLORIDE 0.2% AND POTASSIUM CHLORIDE 30MEQ, DEXTROSE DEXTROSE 5%, SODIUM CHLORIDE 0.2% AND POTASSIUM CHLORIDE 40MEQ, DEXTROSE DEXTROSE 5%, SODIUM CHLORIDE 0.2% AND POTASSIUM CHLORIDE 5MEQ (K), DEXTROSE DEXTROSE 5%, SODIUM CHLORIDE 0.2% AND POTASSIUM CHLORIDE 5MEQ, DEXTROSE DEXTROSE 5%, SODIUM CHLORIDE 0.33% AND POTASSIUM CHLORIDE 10MEQ IN PLASTIC CONTAINER, DEXTROSE DEXTROSE 5%, SODIUM CHLORIDE 0.33% AND POTASSIUM CHLORIDE 15MEQ IN PLASTIC CONTAINER, DEXTROSE DEXTROSE 5%, SODIUM CHLORIDE 0.33% AND POTASSIUM CHLORIDE 20MEQ IN PLASTIC CONTAINER, DEXTROSE DEXTROSE 5%, SODIUM CHLORIDE 0.33% AND POTASSIUM CHLORIDE 30MEQ IN PLASTIC CONTAINER, DEXTROSE DEXTROSE 5%, SODIUM CHLORIDE 0.33% AND POTASSIUM CHLORIDE 40MEQ IN PLASTIC CONTAINER, DEXTROSE DEXTROSE 5%, SODIUM CHLORIDE 0.33% AND POTASSIUM CHLORIDE 5MEQ IN PLASTIC CONTAINER, DEXTROSE DEXTROSE 5%, SODIUM CHLORIDE 0.45% AND POTASSIUM CHLORIDE 20MEQ (K) IN PLASTIC CONTAINER, DEXTROSE DEXTROSE 50% IN PLASTIC CONTAINER, DEXTROSE DEXTROSE 60% IN PLASTIC CONTAINER, DEXTROSE DEXTROSE 70% IN PLASTIC CONTAINER, DEXTROSE DIANEAL 137 W/ DEXTROSE 1.5% IN PLASTIC CONTAINER, CALCIUM CHLORIDE DIANEAL 137 W/ DEXTROSE 2.5% IN PLASTIC CONTAINER, CALCIUM CHLORIDE DIANEAL 137 W/ DEXTROSE 4.25% IN PLASTIC CONTAINER, CALCIUM CHLORIDE DIANEAL LOW CALCIUM W/ DEXTROSE 1.5% IN PLASTIC CONTAINER, CALCIUM CHLORIDE DIANEAL LOW CALCIUM W/ DEXTROSE 2.5% IN PLASTIC CONTAINER, CALCIUM CHLORIDE DIANEAL LOW CALCIUM W/ DEXTROSE 3.5% IN PLASTIC CONTAINER, CALCIUM CHLORIDE DIANEAL LOW CALCIUM W/ DEXTROSE 4.25% IN PLASTIC CONTAINER, CALCIUM CHLORIDE DIANEAL PD-1 W/ DEXTROSE 1.5% IN PLASTIC CONTAINER, CALCIUM CHLORIDE DIANEAL PD-1 W/ DEXTROSE 2.5% IN PLASTIC CONTAINER, CALCIUM CHLORIDE DIANEAL PD-1 W/ DEXTROSE 3.5% IN PLASTIC CONTAINER, CALCIUM CHLORIDE DIANEAL PD-1 W/ DEXTROSE 4.25% IN PLASTIC CONTAINER, CALCIUM CHLORIDE DIANEAL PD-2 W/ DEXTROSE 1.5% IN PLASTIC CONTAINER, CALCIUM CHLORIDE DIANEAL PD-2 W/ DEXTROSE 2.5% IN PLASTIC CONTAINER, CALCIUM CHLORIDE DIANEAL PD-2 W/ DEXTROSE 3.5% IN PLASTIC CONTAINER, CALCIUM CHLORIDE DIANEAL PD-2 W/ DEXTROSE 4.25% IN PLASTIC CONTAINER, CALCIUM CHLORIDE DOBUTAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINER, DOBUTAMINE HYDROCHLORIDE DOPAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINER, DOPAMINE HYDROCHLORIDE EXTRANEAL, ICODEXTRIN FAMOTIDINE PRESERVATIVE FREE, FAMOTIDINE FAMOTIDINE, FAMOTIDINE FLAGYL I.V. RTU IN PLASTIC CONTAINER, METRONIDAZOLE FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, FLUCONAZOLE HEPARIN SODIUM 1,000 UNITS AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, HEPARIN SODIUM HEPARIN SODIUM 2,000 UNITS AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, HEPARIN SODIUM HEPARIN SODIUM 20,000 UNITS AND DEXTROSE 5% IN PLASTIC CONTAINER, HEPARIN SODIUM HEPARIN SODIUM 25,000 UNITS AND DEXTROSE 5% IN PLASTIC CONTAINER, HEPARIN SODIUM HEPATASOL 8%, AMINO ACIDS IFEX, IFOSFAMIDE ISOTONIC GENTAMICIN SULFATE IN PLASTIC CONTAINER, GENTAMICIN SULFATE LACTATED RINGER'S AND DEXTROSE 5% IN PLASTIC CONTAINER, CALCIUM CHLORIDE LACTATED RINGER'S IN PLASTIC CONTAINER, CALCIUM CHLORIDE LIDOCAINE HYDROCHLORIDE 0.2% AND DEXTROSE 5% IN PLASTIC CONTAINER, LIDOCAINE HYDROCHLORIDE LIDOCAINE HYDROCHLORIDE 0.4% AND DEXTROSE 5% IN PLASTIC CONTAINER, LIDOCAINE HYDROCHLORIDE LIDOCAINE HYDROCHLORIDE 0.8% AND DEXTROSE 5% IN PLASTIC CONTAINER, LIDOCAINE HYDROCHLORIDE

SEPTEMBER 2010 - APPROVED DRUG PRODUCTS LIST

B - 28

APPENDIX B

PRODUCT NAME SORTED BY APPLICANT


** B **

* BAXTER HEALTHCARE CORP MESNEX, MESNA MILRINONE LACTATE IN DEXTROSE 5% IN PLASTIC CONTAINER, MILRINONE LACTATE NALLPEN IN PLASTIC CONTAINER, NAFCILLIN SODIUM NITROGLYCERIN IN DEXTROSE 5%, NITROGLYCERIN ONDANSETRON HYDROCHLORIDE AND SODIUM CHLORIDE IN PLASTIC CONTAINER, ONDANSETRON HYDROCHLORIDE OSMITROL 10% IN WATER IN PLASTIC CONTAINER, MANNITOL OSMITROL 10% IN WATER, MANNITOL OSMITROL 15% IN WATER IN PLASTIC CONTAINER, MANNITOL OSMITROL 15% IN WATER, MANNITOL OSMITROL 20% IN WATER IN PLASTIC CONTAINER, MANNITOL OSMITROL 20% IN WATER, MANNITOL OSMITROL 5% IN WATER IN PLASTIC CONTAINER, MANNITOL OSMITROL 5% IN WATER, MANNITOL PENICILLIN G POTASSIUM IN PLASTIC CONTAINER, PENICILLIN G POTASSIUM PHENYTOIN SODIUM, PHENYTOIN SODIUM PLASMA-LYTE 148 AND DEXTROSE 5% IN PLASTIC CONTAINER, DEXTROSE PLASMA-LYTE 148 IN WATER IN PLASTIC CONTAINER, MAGNESIUM CHLORIDE PLASMA-LYTE 56 AND DEXTROSE 5% IN PLASTIC CONTAINER, DEXTROSE PLASMA-LYTE 56 IN PLASTIC CONTAINER, MAGNESIUM ACETATE TETRAHYDRATE PLASMA-LYTE A IN PLASTIC CONTAINER, MAGNESIUM CHLORIDE PLASMA-LYTE M AND DEXTROSE 5% IN PLASTIC CONTAINER, CALCIUM CHLORIDE PLASMA-LYTE R IN PLASTIC CONTAINER, CALCIUM CHLORIDE POTASSIUM CHLORIDE 0.15% IN SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER, POTASSIUM CHLORIDE POTASSIUM CHLORIDE 0.15% IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, POTASSIUM CHLORIDE POTASSIUM CHLORIDE 0.224% IN SODIUM CHLORIDE 0.9%, POTASSIUM CHLORIDE POTASSIUM CHLORIDE 0.3% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, POTASSIUM CHLORIDE POTASSIUM CHLORIDE 10MEQ IN DEXTROSE 5% AND LACTATED RINGER'S IN PLASTIC CONTAINER, CALCIUM CHLORIDE POTASSIUM CHLORIDE 10MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER, DEXTROSE POTASSIUM CHLORIDE 10MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, DEXTROSE POTASSIUM CHLORIDE 10MEQ IN PLASTIC CONTAINER, POTASSIUM CHLORIDE POTASSIUM CHLORIDE 15MEQ IN DEXTROSE 5% AND LACTATED RINGER'S IN PLASTIC CONTAINER, CALCIUM CHLORIDE POTASSIUM CHLORIDE 20MEQ IN DEXTROSE 5% AND LACTATED RINGER'S IN PLASTIC CONTAINER, CALCIUM CHLORIDE POTASSIUM CHLORIDE 20MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER, DEXTROSE POTASSIUM CHLORIDE 20MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, DEXTROSE POTASSIUM CHLORIDE 20MEQ IN PLASTIC CONTAINER, POTASSIUM CHLORIDE POTASSIUM CHLORIDE 30MEQ IN DEXTROSE 5% AND LACTATED RINGER'S IN PLASTIC CONTAINER, CALCIUM CHLORIDE POTASSIUM CHLORIDE 30MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER, DEXTROSE POTASSIUM CHLORIDE 30MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, DEXTROSE POTASSIUM CHLORIDE 30MEQ IN PLASTIC CONTAINER, POTASSIUM CHLORIDE POTASSIUM CHLORIDE 40MEQ IN DEXTROSE 5% AND LACTATED RINGER'S IN PLASTIC CONTAINER, CALCIUM CHLORIDE POTASSIUM CHLORIDE 40MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER, DEXTROSE POTASSIUM CHLORIDE 40MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, DEXTROSE POTASSIUM CHLORIDE 40MEQ IN PLASTIC CONTAINER, POTASSIUM CHLORIDE POTASSIUM CHLORIDE 5MEQ IN DEXTROSE 5% AND LACTATED RINGER'S IN PLASTIC CONTAINER, CALCIUM CHLORIDE POTASSIUM CHLORIDE 5MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER, DEXTROSE POTASSIUM CHLORIDE 5MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, DEXTROSE
POTASSIUM CHLORIDE, POTASSIUM CHLORIDE
PREMASOL 10% IN PLASTIC CONTAINER, AMINO ACIDS
PREMASOL 6% IN PLASTIC CONTAINER, AMINO ACIDS

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APPENDIX B

PRODUCT NAME SORTED BY APPLICANT


** B **

* BAXTER HEALTHCARE CORP RENAMIN W/O ELECTROLYTES, AMINO ACIDS RINGER'S IN PLASTIC CONTAINER, CALCIUM CHLORIDE SEVOFLURANE, SEVOFLURANE SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER, SODIUM CHLORIDE SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, SODIUM CHLORIDE SODIUM CHLORIDE 0.9% IN STERILE PLASTIC CONTAINER, SODIUM CHLORIDE SODIUM CHLORIDE 3% IN PLASTIC CONTAINER, SODIUM CHLORIDE SODIUM CHLORIDE 5% IN PLASTIC CONTAINER, SODIUM CHLORIDE SODIUM LACTATE 0.167 MOLAR IN PLASTIC CONTAINER, SODIUM LACTATE SORBITOL 3% IN PLASTIC CONTAINER, SORBITOL STERILE WATER FOR INJECTION IN PLASTIC CONTAINER, STERILE WATER FOR INJECTION STERILE WATER IN PLASTIC CONTAINER, STERILE WATER FOR IRRIGATION STERILE WATER, STERILE WATER FOR IRRIGATION THEOPHYLLINE AND DEXTROSE 5% IN PLASTIC CONTAINER, THEOPHYLLINE TIS-U-SOL IN PLASTIC CONTAINER, MAGNESIUM SULFATE TIS-U-SOL, MAGNESIUM SULFATE TRAVASOL 10% IN PLASTIC CONTAINER, AMINO ACIDS TRAVASOL 10% W/O ELECTROLYTES, AMINO ACIDS TRAVASOL 3.5% SULFITE FREE W/ ELECTROLYTES IN PLASTIC CONTAINER, AMINO ACIDS TRAVASOL 3.5% W/ ELECTROLYTES, AMINO ACIDS TRAVASOL 5.5% IN PLASTIC CONTAINER, AMINO ACIDS TRAVASOL 5.5% SULFITE FREE W/ ELECTROLYTES IN PLASTIC CONTAINER, AMINO ACIDS TRAVASOL 5.5% W/ ELECTROLYTES, AMINO ACIDS TRAVASOL 5.5% W/O ELECTROLYTES, AMINO ACIDS TRAVASOL 8.5% IN PLASTIC CONTAINER, AMINO ACIDS TRAVASOL 8.5% SULFITE FREE W/ ELECTROLYTES IN PLASTIC CONTAINER, AMINO ACIDS TRAVASOL 8.5% W/ ELECTROLYTES, AMINO ACIDS TRAVASOL 8.5% W/O ELECTROLYTES, AMINO ACIDS VANCOCIN HYDROCHLORIDE IN PLASTIC CONTAINER, VANCOMYCIN HYDROCHLORIDE * BAXTER HEALTHCARE CORP ANESTHESIA AND CRITICAL CARE ACYCLOVIR IN SODIUM CHLORIDE 0.9% PRESERVATIVE FREE, ACYCLOVIR SODIUM ACYCLOVIR SODIUM, ACYCLOVIR SODIUM AMPICILLIN AND SULBACTAM, AMPICILLIN SODIUM BUMETANIDE, BUMETANIDE CEFOXITIN, CEFOXITIN SODIUM CHLORPROMAZINE HYDROCHLORIDE, CHLORPROMAZINE HYDROCHLORIDE CLINDAMYCIN PHOSPHATE, CLINDAMYCIN PHOSPHATE CYCLOPHOSPHAMIDE, CYCLOPHOSPHAMIDE DEXAMETHASONE SODIUM PHOSPHATE, DEXAMETHASONE SODIUM PHOSPHATE DIGOXIN, DIGOXIN DILTIAZEM HYDROCHLORIDE, DILTIAZEM HYDROCHLORIDE DIPHENHYDRAMINE HYDROCHLORIDE, DIPHENHYDRAMINE HYDROCHLORIDE DIPYRIDAMOLE, DIPYRIDAMOLE DOPRAM, DOXAPRAM HYDROCHLORIDE DURAMORPH PF, MORPHINE SULFATE FAMOTIDINE PRESERVATIVE FREE, FAMOTIDINE FAMOTIDINE, FAMOTIDINE FENTANYL CITRATE PRESERVATIVE FREE, FENTANYL CITRATE FLUMAZENIL, FLUMAZENIL FOSPHENYTOIN SODIUM, FOSPHENYTOIN SODIUM GRANISETRON HYDROCHLORIDE, GRANISETRON HYDROCHLORIDE HEPARIN SODIUM, HEPARIN SODIUM INFUMORPH, MORPHINE SULFATE KETOROLAC TROMETHAMINE, KETOROLAC TROMETHAMINE MIDAZOLAM HYDROCHLORIDE, MIDAZOLAM HYDROCHLORIDE MILRINONE LACTATE, MILRINONE LACTATE MITOMYCIN, MITOMYCIN ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE, ONDANSETRON HYDROCHLORIDE ONDANSETRON HYDROCHLORIDE, ONDANSETRON HYDROCHLORIDE PROCHLORPERAZINE EDISYLATE, PROCHLORPERAZINE EDISYLATE PROMETHAZINE HYDROCHLORIDE, PROMETHAZINE HYDROCHLORIDE ROBINUL, GLYCOPYRROLATE SUFENTANIL CITRATE, SUFENTANIL CITRATE
TOBRAMYCIN SULFATE, TOBRAMYCIN SULFATE

SEPTEMBER 2010 - APPROVED DRUG PRODUCTS LIST

B - 30

APPENDIX B

PRODUCT NAME SORTED BY APPLICANT


** B **

* BAXTER HEALTHCARE CORP ANESTHESIA AND CRITICAL CARE VINORELBINE TARTRATE, VINORELBINE TARTRATE * BAXTER HEALTHCARE INTERNATI0NAL SPECIALTY THERAPIES DIV FAMOTIDINE PRESERVATIVE FREE IN PLASTIC CONTAINER, FAMOTIDINE
PROSOL 20% SULFITE FREE IN PLASTIC CONTAINER, AMINO ACIDS
BAXTER HLTHCARE CORP * BAXTER HEALTHCARE CORP ANESTHESIA CRITICAL CARE ATIVAN, LORAZEPAM BREVIBLOC DOUBLE STRENGTH IN PLASTIC CONTAINER, ESMOLOL HYDROCHLORIDE BREVIBLOC IN PLASTIC CONTAINER, ESMOLOL HYDROCHLORIDE BREVIBLOC, ESMOLOL HYDROCHLORIDE ETHRANE, ENFLURANE FORANE, ISOFLURANE KETOROLAC TROMETHAMINE, KETOROLAC TROMETHAMINE MEPERIDINE HYDROCHLORIDE, MEPERIDINE HYDROCHLORIDE MIDAZOLAM HYDROCHLORIDE, MIDAZOLAM HYDROCHLORIDE OXYTOCIN, OXYTOCIN PROPRANOLOL HYDROCHLORIDE, PROPRANOLOL HYDROCHLORIDE PROTOPAM CHLORIDE, PRALIDOXIME CHLORIDE REGLAN, METOCLOPRAMIDE HYDROCHLORIDE ROBAXIN, METHOCARBAMOL
SUPRANE, DESFLURANE
BAYER * BAYER HEALTHCARE LLC ALEVE, NAPROXEN SODIUM (OTC) ALEVE-D SINUS & COLD, NAPROXEN SODIUM (OTC)
FEMSTAT 3, BUTOCONAZOLE NITRATE (OTC)
BAYER HLTHCARE * BAYER HEALTHCARE PHARMACEUTICALS INC ADALAT CC, NIFEDIPINE ANGELIQ, DROSPIRENONE AVELOX IN SODIUM CHLORIDE 0.8% IN PLASTIC CONTAINER, MOXIFLOXACIN HYDROCHLORIDE AVELOX, MOXIFLOXACIN HYDROCHLORIDE BETAPACE AF, SOTALOL HYDROCHLORIDE BETAPACE, SOTALOL HYDROCHLORIDE BILTRICIDE, PRAZIQUANTEL CIPRO IN DEXTROSE 5% IN PLASTIC CONTAINER, CIPROFLOXACIN CIPRO XR, CIPROFLOXACIN CIPRO, CIPROFLOXACIN CIPRO, CIPROFLOXACIN HYDROCHLORIDE CLIMARA PRO, ESTRADIOL CLIMARA, ESTRADIOL DTIC-DOME, DACARBAZINE EOVIST, GADOXETATE DISODIUM LEVITRA, VARDENAFIL HYDROCHLORIDE MAGNEVIST, GADOPENTETATE DIMEGLUMINE MENOSTAR, ESTRADIOL MIRENA, LEVONORGESTREL MYCELEX, CLOTRIMAZOLE NEXAVAR, SORAFENIB TOSYLATE PRECOSE, ACARBOSE REFLUDAN, LEPIRUDIN RECOMBINANT TRASYLOL, APROTININ ULTRAVIST (PHARMACY BULK), IOPROMIDE ULTRAVIST 150, IOPROMIDE ULTRAVIST 240, IOPROMIDE ULTRAVIST 300 IN PLASTIC CONTAINER, IOPROMIDE ULTRAVIST 300, IOPROMIDE ULTRAVIST 370, IOPROMIDE YASMIN, DROSPIRENONE
YAZ, DROSPIRENONE

SEPTEMBER 2010 - APPROVED DRUG PRODUCTS LIST

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APPENDIX B

PRODUCT NAME SORTED BY APPLICANT


** B **

BAYER PHARMS * BAYER PHARMACEUTICALS CORP MYCELEX-7 COMBINATION PACK, CLOTRIMAZOLE MYCELEX-7, CLOTRIMAZOLE (OTC)
BEAUFOUR IPSEN * BEAUFOUR IPSEN PHARMA SOMATULINE DEPOT, LANREOTIDE ACETATE

(OTC)

BECTON DICKINSON * BECTON DICKINSON AND CO CHLORHEXIDINE GLUCONATE, CHLORHEXIDINE GLUCONATE E-Z SCRUB 201, POVIDONE-IODINE (OTC)
E-Z SCRUB 241, POVIDONE-IODINE (OTC)

(OTC)

BEDFORD * BEDFORD LABORATORIES DIV BEN VENUE LABORATORIES INC ACETAZOLAMIDE SODIUM, ACETAZOLAMIDE SODIUM ACETYLCYSTEINE, ACETYLCYSTEINE ACYCLOVIR SODIUM, ACYCLOVIR SODIUM ADENOSINE, ADENOSINE ALPROSTADIL, ALPROSTADIL AMIKACIN SULFATE, AMIKACIN SULFATE AMIODARONE HYDROCHLORIDE, AMIODARONE HYDROCHLORIDE AMRINONE LACTATE, INAMRINONE LACTATE ATRACURIUM BESYLATE PRESERVATIVE FREE, ATRACURIUM BESYLATE ATRACURIUM BESYLATE, ATRACURIUM BESYLATE AZATHIOPRINE SODIUM, AZATHIOPRINE SODIUM BLEOMYCIN SULFATE, BLEOMYCIN SULFATE BUMETANIDE, BUMETANIDE BUPRENORPHINE HYDROCHLORIDE, BUPRENORPHINE HYDROCHLORIDE BUTORPHANOL TARTRATE PRESERVATIVE FREE, BUTORPHANOL TARTRATE BUTORPHANOL TARTRATE, BUTORPHANOL TARTRATE CARBOPLATIN, CARBOPLATIN CEFTRIAXONE, CEFTRIAXONE SODIUM CERUBIDINE, DAUNORUBICIN HYDROCHLORIDE CHLOROPROCAINE HYDROCHLORIDE, CHLOROPROCAINE HYDROCHLORIDE CISPLATIN, CISPLATIN CLADRIBINE, CLADRIBINE CLINDAMYCIN PHOSPHATE, CLINDAMYCIN PHOSPHATE CYCLOSPORINE, CYCLOSPORINE CYTARABINE, CYTARABINE DACARBAZINE, DACARBAZINE DACTINOMYCIN, DACTINOMYCIN DAUNORUBICIN HYDROCHLORIDE, DAUNORUBICIN HYDROCHLORIDE DEFEROXAMINE MESYLATE, DEFEROXAMINE MESYLATE DEXRAZOXANE HYDROCHLORIDE, DEXRAZOXANE HYDROCHLORIDE DICYCLOMINE HYDROCHLORIDE (PRESERVATIVE-FREE), DICYCLOMINE HYDROCHLORIDE DILTIAZEM HYDROCHLORIDE, DILTIAZEM HYDROCHLORIDE DIPYRIDAMOLE, DIPYRIDAMOLE DOBUTAMINE HYDROCHLORIDE, DOBUTAMINE HYDROCHLORIDE DOXAPRAM HYDROCHLORIDE, DOXAPRAM HYDROCHLORIDE DOXORUBICIN HYDROCHLORIDE, DOXORUBICIN HYDROCHLORIDE DOXYCYCLINE, DOXYCYCLINE HYCLATE ENALAPRILAT, ENALAPRILAT EPIRUBICIN HYDROCHLORIDE, EPIRUBICIN HYDROCHLORIDE ETOMIDATE, ETOMIDATE ETOPOSIDE, ETOPOSIDE FAMOTIDINE PRESERVATIVE FREE, FAMOTIDINE FAMOTIDINE, FAMOTIDINE FLOXURIDINE, FLOXURIDINE FLUCONAZOLE IN SODIUM CHLORIDE 0.9%, FLUCONAZOLE FLUPHENAZINE DECANOATE, FLUPHENAZINE DECANOATE FOSPHENYTOIN SODIUM, FOSPHENYTOIN SODIUM HALOPERIDOL DECANOATE, HALOPERIDOL DECANOATE
HALOPERIDOL, HALOPERIDOL LACTATE

SEPTEMBER 2010 - APPROVED DRUG PRODUCTS LIST

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APPENDIX B

PRODUCT NAME SORTED BY APPLICANT


** B **

* BEDFORD LABORATORIES DIV BEN VENUE LABORATORIES INC INDOMETHACIN SODIUM, INDOMETHACIN SODIUM KETAMINE HYDROCHLORIDE, KETAMINE HYDROCHLORIDE KETOROLAC TROMETHAMINE, KETOROLAC TROMETHAMINE LABETALOL HYDROCHLORIDE, LABETALOL HYDROCHLORIDE LEUCOVORIN CALCIUM PRESERVATIVE FREE, LEUCOVORIN CALCIUM LEUCOVORIN CALCIUM, LEUCOVORIN CALCIUM LEVOCARNITINE, LEVOCARNITINE LORAZEPAM, LORAZEPAM MESNA, MESNA METHOTREXATE SODIUM PRESERVATIVE FREE, METHOTREXATE SODIUM METHOTREXATE SODIUM, METHOTREXATE SODIUM MIDAZOLAM HYDROCHLORIDE, MIDAZOLAM HYDROCHLORIDE MILRINONE LACTATE, MILRINONE LACTATE MITOMYCIN, MITOMYCIN MITOXANTRONE HYDROCHLORIDE, MITOXANTRONE HYDROCHLORIDE NICARDIPINE HYDROCHLORIDE, NICARDIPINE HYDROCHLORIDE NOREPINEPHRINE BITARTRATE, NOREPINEPHRINE BITARTRATE OCTREOTIDE ACETATE (PRESERVATIVE FREE), OCTREOTIDE ACETATE OCTREOTIDE ACETATE, OCTREOTIDE ACETATE ONDANSETRON HYDROCHLORIDE, ONDANSETRON HYDROCHLORIDE PACLITAXEL, PACLITAXEL PAMIDRONATE DISODIUM, PAMIDRONATE DISODIUM PHENTOLAMINE MESYLATE, PHENTOLAMINE MESYLATE POLYMYXIN B SULFATE, POLYMYXIN B SULFATE PROCHLORPERAZINE EDISYLATE, PROCHLORPERAZINE EDISYLATE PROPRANOLOL HYDROCHLORIDE, PROPRANOLOL HYDROCHLORIDE RANITIDINE HYDROCHLORIDE, RANITIDINE HYDROCHLORIDE RIFAMPIN, RIFAMPIN SUMATRIPTAN SUCCINATE, SUMATRIPTAN SUCCINATE TERBUTALINE SULFATE, TERBUTALINE SULFATE THIOTEPA, THIOTEPA VALPROATE SODIUM, VALPROATE SODIUM VECURONIUM BROMIDE, VECURONIUM BROMIDE VINBLASTINE SULFATE, VINBLASTINE SULFATE
VINORELBINE TARTRATE, VINORELBINE TARTRATE
BEDFORD LABS * BEDFORD LABORATORIES ALLOPURINOL SODIUM, ALLOPURINOL SODIUM AMIODARONE HYDROCHLORIDE, AMIODARONE HYDROCHLORIDE CARBOPLATIN, CARBOPLATIN DIHYDROERGOTAMINE MESYLATE, DIHYDROERGOTAMINE MESYLATE ESMOLOL HYDROCHLORIDE, ESMOLOL HYDROCHLORIDE FENOLDOPAM MESYLATE, FENOLDOPAM MESYLATE FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, FLUCONAZOLE FLUMAZENIL, FLUMAZENIL GRANISETRON HYDROCHLORIDE, GRANISETRON HYDROCHLORIDE IDARUBICIN HYDROCHLORIDE, IDARUBICIN HYDROCHLORIDE IRINOTECAN HYDROCHLORIDE, IRINOTECAN HYDROCHLORIDE LORAZEPAM PRESERVATIVE FREE, LORAZEPAM METHYLPREDNISOLONE SODIUM SUCCINATE, METHYLPREDNISOLONE SODIUM SUCCINATE METOPROLOL TARTRATE, METOPROLOL TARTRATE MILRINONE LACTATE IN DEXTROSE 5% IN PLASTIC CONTAINER, MILRINONE LACTATE ONDANSETRON HYDROCHLORIDE AND DEXTROSE IN PLASTIC CONTAINER, ONDANSETRON HYDROCHLORIDE ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE, ONDANSETRON HYDROCHLORIDE ORPHENADRINE CITRATE, ORPHENADRINE CITRATE PENTOSTATIN, PENTOSTATIN
TORSEMIDE, TORSEMIDE
* BEDFORD LABORATORIES INC LEUPROLIDE ACETATE, LEUPROLIDE ACETATE BEIJING DOUBLE CRANE * BEIJING DOUBLE CRANE PHARMACEUTICAL CO LTD FLUOXETINE HYDROCHLORIDE, FLUOXETINE HYDROCHLORIDE
MELOXICAM, MELOXICAM

SEPTEMBER 2010 - APPROVED DRUG PRODUCTS LIST

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APPENDIX B

PRODUCT NAME SORTED BY APPLICANT


** B **

BEJING YABAO * BEIJING YABAO BIOPHARMACEUTICAL CO LTD GALANTAMINE HYDROBROMIDE, GALANTAMINE HYDROBROMIDE
MELOXICAM, MELOXICAM
BELCHER * BELCHER PHARMACEUTICALS INC CEPHALEXIN, CEPHALEXIN BEN VENUE * BEN VENUE LABORATORIES INC FAMOTIDINE PRESERVATIVE FREE, FAMOTIDINE MIDAZOLAM HYDROCHLORIDE, MIDAZOLAM HYDROCHLORIDE
RANITIDINE HYDROCHLORIDE, RANITIDINE HYDROCHLORIDE
BIO NUCLEONICS * BIO NUCLEONICS INC STRONTIUM CHLORIDE SR-89, BIOKEY * BIOKEY INC BENAZEPRIL HYDROCHLORIDE,

STRONTIUM CHLORIDE SR-89

BENAZEPRIL HYDROCHLORIDE

BIOMARIN PHARM * BIOMARIN PHARMACEUTICAL INC KUVAN, SAPROPTERIN DIHYDROCHLORIDE BIONICHE PHARMA * BIONICHE PHARMA USA LLC ALOPRIM, ALLOPURINOL SODIUM AMIODARONE HYDROCHLORIDE, AMIODARONE HYDROCHLORIDE AMPICILLIN AND SULBACTAM, AMPICILLIN SODIUM COSYNTROPIN, COSYNTROPIN DIMETHYL SULFOXIDE, DIMETHYL SULFOXIDE DIPHENHYDRAMINE HYDROCHLORIDE, DIPHENHYDRAMINE HYDROCHLORIDE DOLOPHINE HYDROCHLORIDE, METHADONE HYDROCHLORIDE ENLON, EDROPHONIUM CHLORIDE ENLON-PLUS, ATROPINE SULFATE ESMOLOL HYDROCHLORIDE, ESMOLOL HYDROCHLORIDE FLUOROURACIL, FLUOROURACIL KETAMINE HYDROCHLORIDE, KETAMINE HYDROCHLORIDE MEFOXIN IN PLASTIC CONTAINER, CEFOXITIN SODIUM METHOTREXATE SODIUM PRESERVATIVE FREE, METHOTREXATE SODIUM RIMSO-50, DIMETHYL SULFOXIDE
SOTRADECOL, SODIUM TETRADECYL SULFATE
BIONICHE PHARMA USA * BIONICHE PHARMA USA LLC CARBOPLATIN, CARBOPLATIN DURACLON, CLONIDINE HYDROCHLORIDE EPIRUBICIN HYDROCHLORIDE, EPIRUBICIN HYDROCHLORIDE FOMEPIZOLE, FOMEPIZOLE IBUTILIDE FUMARATE, IBUTILIDE FUMARATE MELPHALAN HYDROCHLORIDE, MELPHALAN HYDROCHLORIDE METHOTREXATE SODIUM PRESERVATIVE FREE, METHOTREXATE SODIUM MITOXANTRONE HYDROCHLORIDE, MITOXANTRONE HYDROCHLORIDE NICARDIPINE HYDROCHLORIDE, NICARDIPINE HYDROCHLORIDE ROCURONIUM BROMIDE, ROCURONIUM BROMIDE
VANCOMYCIN HYDROCHLORIDE, VANCOMYCIN HYDROCHLORIDE
BIONICHE TEORANTA * BIONICHE TEORANTA ULTIVA, REMIFENTANIL HYDROCHLORIDE BIOVAIL * BIOVAIL CORP INTERNATIONAL TIAZAC, DILTIAZEM HYDROCHLORIDE * BIOVAIL LABORATORIES INC ATIVAN, LORAZEPAM
CARDIZEM CD, DILTIAZEM HYDROCHLORIDE

SEPTEMBER 2010 - APPROVED DRUG PRODUCTS LIST

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APPENDIX B

PRODUCT NAME SORTED BY APPLICANT


** B **

* BIOVAIL LABORATORIES INC DICLOFENAC SODIUM, DICLOFENAC SODIUM DILTIAZEM HYDROCHLORIDE, DILTIAZEM HYDROCHLORIDE ISORDIL, ISOSORBIDE DINITRATE NIFEDIPINE, NIFEDIPINE
PENTOXIFYLLINE, PENTOXIFYLLINE
BIOVAIL AMERICAS * BIOVAIL AMERICAS CORP XENAZINE, TETRABENAZINE BIOVAIL LABS INTL * BIOVAIL LABORATORIES INTERNATIONAL SRL APLENZIN, BUPROPION HYDROBROMIDE CARDIZEM LA, DILTIAZEM HYDROCHLORIDE CARDIZEM, DILTIAZEM HYDROCHLORIDE ULTRAM ER, TRAMADOL HYDROCHLORIDE VASERETIC, ENALAPRIL MALEATE VASOTEC, ENALAPRIL MALEATE
WELLBUTRIN XL, BUPROPION HYDROCHLORIDE
BLAIREX * BLAIREX LABORATORIES INC BRONCHO SALINE, SODIUM CHLORIDE

(OTC)

BOCA PHARMA * BOCA PHARMACAL INC ACETAMINOPHEN, CAFFEINE, AND DIHYDROCODEINE BITARTRATE, CARBINOXAMINE MALEATE, CARBINOXAMINE MALEATE LEVETIRACETAM, LEVETIRACETAM
METHSCOPOLAMINE BROMIDE, METHSCOPOLAMINE BROMIDE
BOEHRINGER INGELHEIM * BOEHRINGER INGELHEIM CATAPRES, CLONIDINE HYDROCHLORIDE CATAPRES-TTS-1, CLONIDINE CATAPRES-TTS-2, CLONIDINE CATAPRES-TTS-3, CLONIDINE MICARDIS HCT, HYDROCHLOROTHIAZIDE MICARDIS, TELMISARTAN MIRAPEX, PRAMIPEXOLE DIHYDROCHLORIDE ZANTAC 150, RANITIDINE HYDROCHLORIDE (OTC)
ZANTAC 75, RANITIDINE HYDROCHLORIDE (OTC)
* BOEHRINGER INGELHEIM PHARMACEUTICALS INC AGGRENOX, ASPIRIN APTIVUS, TIPRANAVIR ATROVENT HFA, IPRATROPIUM BROMIDE ATROVENT, IPRATROPIUM BROMIDE COMBIVENT, ALBUTEROL SULFATE FLOMAX, TAMSULOSIN HYDROCHLORIDE MIRAPEX ER, PRAMIPEXOLE DIHYDROCHLORIDE MOBIC, MELOXICAM PERSANTINE, DIPYRIDAMOLE SPIRIVA, TIOTROPIUM BROMIDE MONOHYDRATE TWYNSTA, AMLODIPINE BESYLATE
VIRAMUNE, NEVIRAPINE
BRACCO * BRACCO DIAGNOSTICS INC CARDIOGEN-82, RUBIDIUM CHLORIDE RB-82 CHOLETEC, TECHNETIUM TC-99M MEBROFENIN KIT CHOLOGRAFIN MEGLUMINE, IODIPAMIDE MEGLUMINE CHROMITOPE SODIUM, SODIUM CHROMATE CR-51 CYSTOGRAFIN DILUTE, DIATRIZOATE MEGLUMINE CYSTOGRAFIN, DIATRIZOATE MEGLUMINE GASTROGRAFIN, DIATRIZOATE MEGLUMINE ISOVUE-200, IOPAMIDOL
ISOVUE-250, IOPAMIDOL

ACETAMINOPHEN

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APPENDIX B

PRODUCT NAME SORTED BY APPLICANT


** B **

* BRACCO DIAGNOSTICS INC ISOVUE-300, IOPAMIDOL ISOVUE-370, IOPAMIDOL ISOVUE-M 200, IOPAMIDOL ISOVUE-M 300, IOPAMIDOL KINEVAC, SINCALIDE MDP-BRACCO, TECHNETIUM TC-99M MEDRONATE KIT MULTIHANCE MULTIPACK, GADOBENATE DIMEGLUMINE MULTIHANCE, GADOBENATE DIMEGLUMINE PROHANCE MULTIPACK, GADOTERIDOL PROHANCE, GADOTERIDOL RENOGRAFIN-76, DIATRIZOATE MEGLUMINE
SINOGRAFIN, DIATRIZOATE MEGLUMINE
BRAINTREE * BRAINTREE LABORATORIES INC AXID, NIZATIDINE GOLYTELY, POLYETHYLENE GLYCOL 3350 HALFLYTELY, BISACODYL NULYTELY, POLYETHYLENE GLYCOL 3350
NULYTELY-FLAVORED, POLYETHYLENE GLYCOL 3350
BREATH LTD * BREATH LTD LEVALBUTEROL HYDROCHLORIDE,

LEVALBUTEROL HYDROCHLORIDE

BRECKENRIDGE PHARM * BRECKENRIDGE PHARMACEUTICAL INC CILOSTAZOL, CILOSTAZOL ESTRADIOL AND NORETHINDRONE ACETATE, ESTRADIOL MELOXICAM, MELOXICAM OXCARBAZEPINE, OXCARBAZEPINE
POLYETHYLENE GLYCOL 3350, POLYETHYLENE GLYCOL 3350
BRIGHTSTONE * BRIGHTSTONE PHARMA INC ISOSORBIDE MONONITRATE,

ISOSORBIDE MONONITRATE

BRISTOL * BRISTOL LABORATORIES INC DIV BRISTOL MYERS CO BICNU, CARMUSTINE BRISTOL MYERS * BRISTOL MYERS CO MUTAMYCIN, MITOMYCIN PLATINOL, CISPLATIN PLATINOL-AQ, CISPLATIN QUESTRAN LIGHT, CHOLESTYRAMINE
QUESTRAN, CHOLESTYRAMINE
BRISTOL MYERS SQUIBB * BRISTOL MYERS SQUIBB AZACTAM, AZTREONAM BARACLUDE, ENTECAVIR DEXTROSE 5% AND POTASSIUM CHLORIDE 0.075% IN PLASTIC CONTAINER, DEXTROSE DEXTROSE 5% AND POTASSIUM CHLORIDE 0.15% IN PLASTIC CONTAINER, DEXTROSE DEXTROSE 5% AND POTASSIUM CHLORIDE 0.224% IN PLASTIC CONTAINER, DEXTROSE DEXTROSE 5% AND POTASSIUM CHLORIDE 0.3% IN PLASTIC CONTAINER, DEXTROSE GLUCOVANCE, GLYBURIDE LYSODREN, MITOTANE MEGACE, MEGESTROL ACETATE
PRAVACHOL, PRAVASTATIN SODIUM
* BRISTOL MYERS SQUIBB CO AZACTAM IN PLASTIC CONTAINER, AZTREONAM CEENU, LOMUSTINE DROXIA, HYDROXYUREA ESTRACE, ESTRADIOL GLUCOPHAGE XR, METFORMIN HYDROCHLORIDE
HYDREA, HYDROXYUREA

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APPENDIX B

PRODUCT NAME SORTED BY APPLICANT


** B **

* BRISTOL MYERS SQUIBB CO IXEMPRA KIT, IXABEPILONE METAGLIP, GLIPIZIDE MYCOSTATIN, NYSTATIN ONGLYZA, SAXAGLIPTIN HYDROCHLORIDE PARAPLATIN, CARBOPLATIN REYATAZ, ATAZANAVIR SULFATE SPRYCEL, DASATINIB SUSTIVA, EFAVIRENZ VEPESID, ETOPOSIDE
VIDEX EC, DIDANOSINE
* BRISTOL MYERS SQUIBB CO PHARMACEUTICAL RESEARCH INSTITUTE BLENOXANE, BLEOMYCIN SULFATE BUSPAR, BUSPIRONE HYDROCHLORIDE CEFZIL, CEFPROZIL ESTRACE, ESTRADIOL ETOPOPHOS PRESERVATIVE FREE, ETOPOSIDE PHOSPHATE GLUCOPHAGE, METFORMIN HYDROCHLORIDE MAXIPIME, CEFEPIME HYDROCHLORIDE MONOPRIL, FOSINOPRIL SODIUM TAXOL, PACLITAXEL VIDEX, DIDANOSINE VUMON, TENIPOSIDE
ZERIT, STAVUDINE
* BRISTOL MYERS SQUIBB PHARMA CO COUMADIN, WARFARIN SODIUM LODOSYN, CARBIDOPA SINEMET CR, CARBIDOPA SINEMET, CARBIDOPA
SUSTIVA, EFAVIRENZ
BRYAN * BRYAN CORP SCLEROSOL, TALC
TALC, TALC
CADISTA PHARMS * CADISTA PHARMACEUTICALS INC ALENDRONATE SODIUM, ALENDRONATE SODIUM CYCLOBENZAPRINE HYDROCHLORIDE, CYCLOBENZAPRINE HYDROCHLORIDE FOLIC ACID, FOLIC ACID HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE LAMOTRIGINE, LAMOTRIGINE METHYLPREDNISOLONE, METHYLPREDNISOLONE OXCARBAZEPINE, OXCARBAZEPINE PREDNISONE, PREDNISONE PROCOMP, PROCHLORPERAZINE MALEATE RISPERIDONE, RISPERIDONE
TERAZOSIN HYDROCHLORIDE, TERAZOSIN HYDROCHLORIDE
CANYON * CANYON PHARMACEUTICALS INC IPRIVASK, DESIRUDIN RECOMBINANT CARACO * CARACO PHARMACEUTICAL LABORATORIES LTD ALLOPURINOL, ALLOPURINOL AMITRIPTYLINE HYDROCHLORIDE, AMITRIPTYLINE HYDROCHLORIDE AMLODIPINE BESYLATE, AMLODIPINE BESYLATE ATENOLOL, ATENOLOL BACLOFEN, BACLOFEN CARVEDILOL, CARVEDILOL CETIRIZINE HYDROCHLORIDE ALLERGY, CETIRIZINE HYDROCHLORIDE (OTC) CETIRIZINE HYDROCHLORIDE HIVES RELIEF, CETIRIZINE HYDROCHLORIDE (OTC) CETIRIZINE HYDROCHLORIDE HIVES, CETIRIZINE HYDROCHLORIDE (OTC) CITALOPRAM HYDROBROMIDE, CITALOPRAM HYDROBROMIDE
CLONAZEPAM, CLONAZEPAM

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APPENDIX B

PRODUCT NAME SORTED BY APPLICANT


** C **

* CARACO PHARMACEUTICAL LABORATORIES LTD CLOZAPINE, CLOZAPINE DIGOXIN, DIGOXIN ELIXOPHYLLIN, THEOPHYLLINE FLUMADINE, RIMANTADINE HYDROCHLORIDE FLURBIPROFEN, FLURBIPROFEN FLUVOXAMINE MALEATE, FLUVOXAMINE MALEATE GLIPIZIDE AND METFORMIN HYDROCHLORIDE, GLIPIZIDE GLIPIZIDE, GLIPIZIDE HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE ISOSORBIDE DINITRATE, ISOSORBIDE DINITRATE MELOXICAM, MELOXICAM MEPERIDINE HYDROCHLORIDE, MEPERIDINE HYDROCHLORIDE METFORMIN HYDROCHLORIDE, METFORMIN HYDROCHLORIDE METHIMAZOLE, METHIMAZOLE METOPROLOL TARTRATE, METOPROLOL TARTRATE MIRTAZAPINE, MIRTAZAPINE OXAPROZIN, OXAPROZIN PAROMOMYCIN SULFATE, PAROMOMYCIN SULFATE PAROXETINE HYDROCHLORIDE, PAROXETINE HYDROCHLORIDE PHENTERMINE HYDROCHLORIDE, PHENTERMINE HYDROCHLORIDE SYNALGOS-DC, ASPIRIN THEOCHRON, THEOPHYLLINE TICLOPIDINE HYDROCHLORIDE, TICLOPIDINE HYDROCHLORIDE TIZANIDINE HYDROCHLORIDE, TIZANIDINE HYDROCHLORIDE TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN, ACETAMINOPHEN TRAMADOL HYDROCHLORIDE, TRAMADOL HYDROCHLORIDE VENLAFAXINE HYDROCHLORIDE, VENLAFAXINE HYDROCHLORIDE
ZOLPIDEM TARTRATE, ZOLPIDEM TARTRATE
CARDINAL HEALTH 414 * CARDINAL HEALTH 414 LLC TECHNETIUM TC 99M SESTAMIBI,

TECHNETIUM TC-99M SESTAMIBI KIT

CARLSBAD * CARLSBAD TECHNOLOGY INC ACYCLOVIR, ACYCLOVIR CIPROFLOXACIN HYDROCHLORIDE, CIPROFLOXACIN HYDROCHLORIDE DICLOFENAC SODIUM, DICLOFENAC SODIUM FAMOTIDINE, FAMOTIDINE GLIMEPIRIDE, GLIMEPIRIDE LOVASTATIN, LOVASTATIN MELOXICAM, MELOXICAM
ZOLPIDEM TARTRATE, ZOLPIDEM TARTRATE
CAROLINA MEDCL * CAROLINA MEDICAL PRODUCTS CO AMANTADINE HYDROCHLORIDE, AMANTADINE HYDROCHLORIDE HYDROCORTISONE IN ABSORBASE, HYDROCORTISONE ISONIAZID, ISONIAZID SODIUM POLYSTYRENE SULFONATE, SODIUM POLYSTYRENE SULFONATE SPS, SODIUM POLYSTYRENE SULFONATE
TRIAMCINOLONE ACETONIDE IN ABSORBASE, TRIAMCINOLONE ACETONIDE
CATALENT * CATALENT PHARMA SOLUTIONS LLC NIFEDIPINE, NIFEDIPINE
VALPROIC ACID, VALPROIC ACID
CEDAR PHARMS * CEDAR PHARMACEUTICALS LLC METHIMAZOLE, METHIMAZOLE CELGENE * CELGENE CORP REVLIMID, LENALIDOMIDE THALOMID, THALIDOMIDE
VIDAZA, AZACITIDINE

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APPENDIX B

PRODUCT NAME SORTED BY APPLICANT


** C **

CENTOCOR ORTHO * CENTOCOR ORTHO BIOTECH INC PREZISTA, DARUNAVIR ETHANOLATE CEPH INTL * CEPH INTERNATIONAL CORP CEPHALEXIN, CEPHALEXIN CEPHALON * CEPHALON INC ACTIQ, FENTANYL CITRATE FENTORA, FENTANYL CITRATE GABITRIL, TIAGABINE HYDROCHLORIDE NUVIGIL, ARMODAFINIL PROVIGIL, MODAFINIL TREANDA, BENDAMUSTINE HYDROCHLORIDE
TRISENOX, ARSENIC TRIOXIDE
CEPHAZONE PHARMA * CEPHAZONE PHARMA LLC CEFAZOLIN SODIUM, CEFAZOLIN SODIUM CEFOTAXIME SODIUM, CEFOTAXIME SODIUM
CEFTRIAXONE, CEFTRIAXONE SODIUM
CHATTEM * CHATTEM INC SELSUN, SELENIUM SULFIDE
UNISOM, DOXYLAMINE SUCCINATE

(OTC)

CHEMISCH FBRK KRSSLR * CHEMISCHE FABRIK KREUSSLER & CO. GMBH ASCLERA, POLIDOCANOL CHIRHOCLIN * CHIRHOCLIN INC CHIRHOSTIM, SECRETIN SYNTHETIC HUMAN CIPHER PHARMS INC * CIPHER PHARMACEUTICALS INC LIPOFEN, FENOFIBRATE CIPLA * CIPLA LTD RAMIPRIL, RAMIPRIL
TRANDOLAPRIL, TRANDOLAPRIL
CIPLA LTD * CIPLA LTD GRANISETRON HYDROCHLORIDE, GRANISETRON HYDROCHLORIDE PAMIDRONATE DISODIUM, PAMIDRONATE DISODIUM STAVUDINE, STAVUDINE TOPIRAMATE, TOPIRAMATE ZALEPLON, ZALEPLON
ZIDOVUDINE, ZIDOVUDINE
CITRUSPHRMA * CITRUSPHRMA LLC SODIUM POLYSTYRENE SULFONATE,

SODIUM POLYSTYRENE SULFONATE

CLARIS LIFESCIENCES * CLARIS LIFESCIENCES LTD CIPROFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER, CIPROFLOXACIN CIPROFLOXACIN, CIPROFLOXACIN METRONIDAZOLE IN PLASTIC CONTAINER, METRONIDAZOLE ONDANSETRON HYDROCHLORIDE AND DEXTROSE IN PLASTIC CONTAINER, ONDANSETRON HYDROCHLORIDE CLINTEC NUTR * CLINTEC NUTRITION CO SUB CLINIQUE CLINISOL 15% SULFITE FREE IN PLASTIC CONTAINER,

AMINO ACIDS

SEPTEMBER 2010 - APPROVED DRUG PRODUCTS LIST

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APPENDIX B

PRODUCT NAME SORTED BY APPLICANT


** C **

CNTY LINE PHARMS * COUNTY LINE PHARMACEUTICALS LLC UREX, METHENAMINE HIPPURATE COASTAL PHARMS * COASTAL PHARMACEUTICALS INC LIOTHYRONINE SODIUM, LIOTHYRONINE SODIUM NYSTATIN, NYSTATIN
OXYCODONE AND ACETAMINOPHEN, ACETAMINOPHEN
COBALT * COBALT PHARMACEUTICALS INC AMLODIPINE BESYLATE, AMLODIPINE BESYLATE CIPROFLOXACIN HYDROCHLORIDE, CIPROFLOXACIN HYDROCHLORIDE CITALOPRAM HYDROBROMIDE, CITALOPRAM HYDROBROMIDE FOSINOPRIL SODIUM, FOSINOPRIL SODIUM GLIMEPIRIDE, GLIMEPIRIDE METFORMIN HYDROCHLORIDE, METFORMIN HYDROCHLORIDE RANITIDINE HYDROCHLORIDE, RANITIDINE HYDROCHLORIDE SERTRALINE HYDROCHLORIDE, SERTRALINE HYDROCHLORIDE SIMVASTATIN, SIMVASTATIN
TRANDOLAPRIL, TRANDOLAPRIL
COBALT LABS INC * COBALT LABORATORIES INC ACARBOSE, ACARBOSE ALBUTEROL SULFATE AND IPRATROPIUM BROMIDE, ALBUTEROL SULFATE ALBUTEROL SULFATE, ALBUTEROL SULFATE ALENDRONATE SODIUM, ALENDRONATE SODIUM CABERGOLINE, CABERGOLINE IPRATROPIUM BROMIDE, IPRATROPIUM BROMIDE ISRADIPINE, ISRADIPINE LAMOTRIGINE, LAMOTRIGINE LEVETIRACETAM, LEVETIRACETAM PRAVASTATIN SODIUM, PRAVASTATIN SODIUM RAMIPRIL, RAMIPRIL RISPERIDONE, RISPERIDONE SUMATRIPTAN SUCCINATE, SUMATRIPTAN SUCCINATE
TOPIRAMATE, TOPIRAMATE
COBREK PHARMS * COBREK PHARMACEUTICALS INC CLINDAMYCIN PHOSPHATE, CLINDAMYCIN PHOSPHATE COLGATE * COLGATE ORAL PHARMACEUTICALS INC ORABASE HCA, HYDROCORTISONE ACETATE
PERIOGARD, CHLORHEXIDINE GLUCONATE
COLGATE PALMOLIVE * COLGATE PALMOLIVE COLGATE TOTAL, SODIUM FLUORIDE COLUMBIA LABS * COLUMBIA LABORATORIES INC CRINONE, PROGESTERONE
STRIANT, TESTOSTERONE
CONCORD LABS NJ * CONCORD LABORATORIES INC BUTALBITAL, ACETAMINOPHEN AND CAFFEINE, ACETAMINOPHEN CARISOPRODOL AND ASPIRIN, ASPIRIN CARISOPRODOL, CARISOPRODOL CARISOPRODOL, ASPIRIN AND CODEINE PHOSPHATE, ASPIRIN PROBENECID AND COLCHICINE, COLCHICINE
PROPOXYPHENE NAPSYLATE AND ACETAMINOPHEN, ACETAMINOPHEN
CONNECTICS * CONNECTICS CORP LUXIQ, BETAMETHASONE VALERATE

(OTC)

SEPTEMBER 2010 - APPROVED DRUG PRODUCTS LIST

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APPENDIX B

PRODUCT NAME SORTED BY APPLICANT

** C **

CONNETICS * CONNETICS CORP OLUX, CLOBETASOL PROPIONATE CONTRACT PHARMA * CONTRACT PHARMACAL CORP CETIRIZINE HYDROCHLORIDE ALLERGY,

CETIRIZINE HYDROCHLORIDE

(OTC)

CONTRACT PHARMACAL * CONTRACT PHARMACAL CORP CIMETIDINE, CIMETIDINE (OTC) FOLIC ACID, FOLIC ACID IBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE, IBUPROFEN (OTC)
IBUPROFEN, IBUPROFEN
IBUPROFEN, IBUPROFEN (OTC)
LOPERAMIDE HYDROCHLORIDE, LOPERAMIDE HYDROCHLORIDE (OTC)
NAPROXEN SODIUM, NAPROXEN SODIUM (OTC)
PREDNISONE, PREDNISONE
PROFEN, IBUPROFEN (OTC)
RANITIDINE HYDROCHLORIDE, RANITIDINE HYDROCHLORIDE (OTC)
CONTROLLED THERAP * CONTROLLED THERAPEUTICS (SCOTLAND) LTD CERVIDIL, DINOPROSTONE COREPHARMA * COREPHARMA LLC ALPRAZOLAM, ALPRAZOLAM BENZPHETAMINE HYDROCHLORIDE, BENZPHETAMINE HYDROCHLORIDE BENZTROPINE MESYLATE, BENZTROPINE MESYLATE CARISOPRODOL, CARISOPRODOL CILOSTAZOL, CILOSTAZOL CITALOPRAM HYDROBROMIDE, CITALOPRAM HYDROBROMIDE CLINDAMYCIN HYDROCHLORIDE, CLINDAMYCIN HYDROCHLORIDE CYPROHEPTADINE HYDROCHLORIDE, CYPROHEPTADINE HYDROCHLORIDE DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE, ASPARTATE DIETHYLPROPION HYDROCHLORIDE, DIETHYLPROPION HYDROCHLORIDE DOXYCYCLINE HYCLATE, DOXYCYCLINE HYCLATE GLIMEPIRIDE, GLIMEPIRIDE GLIPIZIDE AND METFORMIN HYDROCHLORIDE, GLIPIZIDE GLYBURIDE AND METFORMIN HYDROCHLORIDE, GLYBURIDE GLYBURIDE, GLYBURIDE GLYCOPYRROLATE, GLYCOPYRROLATE GRANISETRON HYDROCHLORIDE, GRANISETRON HYDROCHLORIDE ISOSORBIDE DINITRATE, ISOSORBIDE DINITRATE LEVOCARNITINE, LEVOCARNITINE MELOXICAM, MELOXICAM METHENAMINE HIPPURATE, METHENAMINE HIPPURATE OXYCODONE HYDROCHLORIDE, OXYCODONE HYDROCHLORIDE PILOCARPINE HYDROCHLORIDE, PILOCARPINE HYDROCHLORIDE POTASSIUM CITRATE, POTASSIUM CITRATE PYRIDOSTIGMINE BROMIDE, PYRIDOSTIGMINE BROMIDE RIMANTADINE HYDROCHLORIDE, RIMANTADINE HYDROCHLORIDE ROPINIROLE HYDROCHLORIDE, ROPINIROLE HYDROCHLORIDE TIZANIDINE HYDROCHLORIDE, TIZANIDINE HYDROCHLORIDE TRANDOLAPRIL, TRANDOLAPRIL URSODIOL, URSODIOL ZONISAMIDE, ZONISAMIDE CORIA * CORIA LABORATORIES LTD NUTRACORT, HYDROCORTISONE CORNERSTONE * CORNERSTONE BIOPHARMA INC PROPOXYPHENE NAPSYLATE AND ACETAMINOPHEN, SPECTRACEF, CEFDITOREN PIVOXIL

AMPHETAMINE

ACETAMINOPHEN

SEPTEMBER 2010 - APPROVED DRUG PRODUCTS LIST

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APPENDIX B

PRODUCT NAME SORTED BY APPLICANT


** C **

CORNERSTONE THERAP * CORNERSTONE THERAPEUTICS INC CUROSURF, PORACTANT ALFA COVENANT PHARMA INC * CONVENANT PHARMA INC DEMECLOCYCLINE HYDROCHLORIDE, ETHOSUXIMIDE, ETHOSUXIMIDE
CP PHARMS * CP PHARMACEUTICALS CV LYRICA, PREGABALIN CPPI CV * CP PHARMACEUTICALS INTERNATIONAL CV SUTENT, SUNITINIB MALATE CRITICAL * CRITICAL THERAPEUTICS INC ZYFLO CR, ZILEUTON
ZYFLO, ZILEUTON
CSL BEHRING * CSL BEHRING LLC STIMATE, DESMOPRESSIN ACETATE CUBIST * CUBIST PHARMACEUTICALS INC CUBICIN, DAPTOMYCIN CUMBERLAND PHARMS * CUMBERLAND PHARMACEUTICALS INC ACETADOTE, ACETYLCYSTEINE
CALDOLOR, IBUPROFEN
CYPRESS BIOSCIENCE * CYPRESS BIOSCIENCE INC SAVELLA, MILNACIPRAN HYDROCHLORIDE CYPRESS PHARM * CYPRESS PHARMACEUTICAL INC CETIRIZINE HYDROCHLORIDE, CETIRIZINE HYDROCHLORIDE CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY, CETIRIZINE HYDROCHLORIDE (OTC) CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF, CETIRIZINE HYDROCHLORIDE (OTC) ELIPHOS, CALCIUM ACETATE GRANISETRON HYDROCHLORIDE, GRANISETRON HYDROCHLORIDE LEVETIRACETAM, LEVETIRACETAM
RANITIDINE HYDROCHLORIDE, RANITIDINE HYDROCHLORIDE
DAIICHI * DAIICHI PHARMACEUTICAL CORP FLOXIN OTIC, OFLOXACIN DAIICHI SANKYO * DAIICHI SANKYO INC AZOR, AMLODIPINE BESYLATE BENICAR HCT, HYDROCHLOROTHIAZIDE BENICAR, OLMESARTAN MEDOXOMIL
WELCHOL, COLESEVELAM HYDROCHLORIDE
DAIICHI SANKYO CO * DAIICHI SANKYO CO LTD EVOXAC, CEVIMELINE HYDROCHLORIDE DANCO LABS LLC * DANCO LABORATORIES LLC MIFEPREX, MIFEPRISTONE DAVA INTL INC * DAVA INTERNATIONAL INC ALPRAZOLAM, ALPRAZOLAM

DEMECLOCYCLINE HYDROCHLORIDE

SEPTEMBER 2010 - APPROVED DRUG PRODUCTS LIST

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APPENDIX B

PRODUCT NAME SORTED BY APPLICANT


** D **

DAVA PHARMS INC * DAVA PHARMACEUTICALS INC ACYCLOVIR, ACYCLOVIR AMOXICILLIN, AMOXICILLIN AMPICILLIN TRIHYDRATE, AMPICILLIN/AMPICILLIN TRIHYDRATE ATENOLOL, ATENOLOL CIMETIDINE HYDROCHLORIDE, CIMETIDINE HYDROCHLORIDE CIMETIDINE, CIMETIDINE CLONIDINE HYDROCHLORIDE, CLONIDINE HYDROCHLORIDE DIAZEPAM, DIAZEPAM DILTIAZEM HYDROCHLORIDE, DILTIAZEM HYDROCHLORIDE DOXAZOSIN MESYLATE, DOXAZOSIN MESYLATE FUROSEMIDE, FUROSEMIDE GEMFIBROZIL, GEMFIBROZIL GLYBURIDE (MICRONIZED), GLYBURIDE HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE METHOTREXATE SODIUM, METHOTREXATE SODIUM NAPROXEN, NAPROXEN PENICILLIN V POTASSIUM, PENICILLIN V POTASSIUM PROPYLTHIOURACIL, PROPYLTHIOURACIL PYRAZINAMIDE, PYRAZINAMIDE SELEGILINE HYDROCHLORIDE, SELEGILINE HYDROCHLORIDE
VOSPIRE ER, ALBUTEROL SULFATE
DAVIS AND GECK * DAVIS AND GECK DIV AMERICAN CYANAMID CO PRE-OP II, HEXACHLOROPHENE
PRE-OP, HEXACHLOROPHENE
DEL RAY LABS * DEL RAY LABORATORIES INC ALA-CORT, HYDROCORTISONE ALA-SCALP, HYDROCORTISONE
TRIDERM, TRIAMCINOLONE ACETONIDE
DENTSPLY PHARM * DENTSPLY PHARMACEUTICAL CITANEST FORTE DENTAL, EPINEPHRINE BITARTRATE CITANEST PLAIN DENTAL, PRILOCAINE HYDROCHLORIDE ORAQIX, LIDOCAINE POLOCAINE, MEPIVACAINE HYDROCHLORIDE XYLOCAINE DENTAL WITH EPINEPHRINE, EPINEPHRINE
XYLOCAINE DENTAL, LIDOCAINE HYDROCHLORIDE
DEPOMED INC * DEPOMED INC GLUMETZA, METFORMIN HYDROCHLORIDE
PROQUIN XR, CIPROFLOXACIN HYDROCHLORIDE
DEPROCO * DEPROCO INC LIGNOSPAN FORTE, EPINEPHRINE BITARTRATE LIGNOSPAN STANDARD, EPINEPHRINE BITARTRATE SCANDONEST L, LEVONORDEFRIN SCANDONEST PLAIN, MEPIVACAINE HYDROCHLORIDE
SEPTOCAINE, ARTICAINE HYDROCHLORIDE
DEXCEL LTD * DEXCEL LTD DICLOFENAC SODIUM, DICLOFENAC SODIUM
ISOSORBIDE MONONITRATE, ISOSORBIDE MONONITRATE
DEXCEL PHARMA * DEXCEL PHARMA TECHNOLOGIES LTD OMEPRAZOLE, OMEPRAZOLE (OTC)
PERIOCHIP, CHLORHEXIDINE GLUCONATE

SEPTEMBER 2010 - APPROVED DRUG PRODUCTS LIST

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APPENDIX B

PRODUCT NAME SORTED BY APPLICANT


** D **

DEY * DEY LP ACCUNEB, ALBUTEROL SULFATE ALBUTEROL SULFATE, ALBUTEROL SULFATE CROMOLYN SODIUM, CROMOLYN SODIUM DUONEB, ALBUTEROL SULFATE IPRATROPIUM BROMIDE, IPRATROPIUM BROMIDE LEVALBUTEROL HYDROCHLORIDE, LEVALBUTEROL HYDROCHLORIDE
METAPROTERENOL SULFATE, METAPROTERENOL SULFATE
DEY LP * DEY LP PERFOROMIST,

FORMOTEROL FUMARATE

DIALYSIS SUPS * DIALYSIS SUPPLIES INC NORMOCARB HF 25, MAGNESIUM CHLORIDE


NORMOCARB HF 35, MAGNESIUM CHLORIDE
DORC * DORC INTERNATIONAL BV MEMBRANEBLUE, TRYPAN BLUE
VISIONBLUE, TRYPAN BLUE
DOW PHARM SCI * DOW PHARMACEUTICAL SCIENCES ACANYA, BENZOYL PEROXIDE DOW PHARM SCIENCES * DOW PHARMACEUTICAL SCIENCES INC AKNE-MYCIN, ERYTHROMYCIN ATRALIN, TRETINOIN CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE, CLODERM, CLOCORTOLONE PIVALATE
DR REDDYS LA * DR REDDYS LABORATORIES LOUISIANA LLC IBUPROFEN, IBUPROFEN IBUPROFEN, IBUPROFEN (OTC) LOPURIN, ALLOPURINOL SSD AF, SILVER SULFADIAZINE
SSD, SILVER SULFADIAZINE
DR REDDYS LABS * DR REDDYS LABORATORIES LTD OMEPRAZOLE, OMEPRAZOLE DR REDDYS LABS INC * DR REDDYS LABORATORIES INC AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE, AMLODIPINE BESYLATE FINASTERIDE, FINASTERIDE FLUCONAZOLE, FLUCONAZOLE FLUOXETINE HYDROCHLORIDE, FLUOXETINE HYDROCHLORIDE GLYBURIDE AND METFORMIN HYDROCHLORIDE, GLYBURIDE GRANISETRON HYDROCHLORIDE PRESERVATIVE FREE, GRANISETRON HYDROCHLORIDE GRANISETRON HYDROCHLORIDE, GRANISETRON HYDROCHLORIDE IBUPROFEN, IBUPROFEN IBUPROFEN, IBUPROFEN (OTC) MELOXICAM, MELOXICAM METFORMIN HYDROCHLORIDE, METFORMIN HYDROCHLORIDE NAPROXEN SODIUM AND PSEUDOEPHEDRINE HYDROCHLORIDE, NAPROXEN SODIUM (OTC) NAPROXEN SODIUM, NAPROXEN SODIUM (OTC) NEFAZODONE HYDROCHLORIDE, NEFAZODONE HYDROCHLORIDE PRAVASTATIN SODIUM, PRAVASTATIN SODIUM RANITIDINE HYDROCHLORIDE, RANITIDINE HYDROCHLORIDE RIVASTIGMINE TARTRATE, RIVASTIGMINE TARTRATE SIMVASTATIN, SIMVASTATIN SUMATRIPTAN SUCCINATE, SUMATRIPTAN SUCCINATE
TERBINAFINE HYDROCHLORIDE, TERBINAFINE HYDROCHLORIDE

BENZOYL PEROXIDE

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APPENDIX B
* DR REDDYS LABORATORIES INC TIZANIDINE HYDROCHLORIDE,

PRODUCT NAME SORTED BY APPLICANT


** D **

TIZANIDINE HYDROCHLORIDE

DR REDDYS LABS LTD * DR REDDYS LABORATORIES LTD ALENDRONATE SODIUM, ALENDRONATE SODIUM AMLODIPINE BESYLATE, AMLODIPINE BESYLATE BUSPIRONE HYDROCHLORIDE, BUSPIRONE HYDROCHLORIDE CARVEDILOL, CARVEDILOL CETIRIZINE HYDROCHLORIDE ALLERGY, CETIRIZINE HYDROCHLORIDE (OTC) CETIRIZINE HYDROCHLORIDE HIVES, CETIRIZINE HYDROCHLORIDE (OTC) CETIRIZINE HYDROCHLORIDE, CETIRIZINE HYDROCHLORIDE CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY, CETIRIZINE HYDROCHLORIDE (OTC) CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF, CETIRIZINE HYDROCHLORIDE (OTC) CIPROFLOXACIN EXTENDED RELEASE, CIPROFLOXACIN CIPROFLOXACIN HYDROCHLORIDE, CIPROFLOXACIN HYDROCHLORIDE CITALOPRAM HYDROBROMIDE, CITALOPRAM HYDROBROMIDE DIVALPROEX SODIUM, DIVALPROEX SODIUM ENALAPRIL MALEATE AND HYDROCHLOROTHIAZIDE, ENALAPRIL MALEATE FAMOTIDINE, FAMOTIDINE FAMOTIDINE, FAMOTIDINE (OTC) FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE, FEXOFENADINE HYDROCHLORIDE FEXOFENADINE HYDROCHLORIDE, FEXOFENADINE HYDROCHLORIDE FINASTERIDE, FINASTERIDE FLUOXETINE HYDROCHLORIDE, FLUOXETINE HYDROCHLORIDE GALANTAMINE HYDROBROMIDE, GALANTAMINE HYDROBROMIDE GLIMEPIRIDE, GLIMEPIRIDE GLYCOPYRROLATE, GLYCOPYRROLATE GRANISETRON HYDROCHLORIDE, GRANISETRON HYDROCHLORIDE IBUPROFEN AND DIPHENHYDRAMINE CITRATE, DIPHENHYDRAMINE CITRATE (OTC) IBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE, IBUPROFEN (OTC) IBUPROFEN, IBUPROFEN (OTC) LAMOTRIGINE, LAMOTRIGINE LEVETIRACETAM, LEVETIRACETAM MEMANTINE HYDROCHLORIDE, MEMANTINE HYDROCHLORIDE MINOCYCLINE HYDROCHLORIDE, MINOCYCLINE HYDROCHLORIDE NABUMETONE, NABUMETONE NAPROXEN SODIUM, NAPROXEN SODIUM NATEGLINIDE, NATEGLINIDE NIZATIDINE, NIZATIDINE OFLOXACIN, OFLOXACIN OMEPRAZOLE MAGNESIUM, OMEPRAZOLE MAGNESIUM (OTC) OMEPRAZOLE, OMEPRAZOLE ONDANSETRON HYDROCHLORIDE, ONDANSETRON HYDROCHLORIDE OXAPROZIN, OXAPROZIN PRIMIDONE, PRIMIDONE RAMIPRIL, RAMIPRIL RANITIDINE HYDROCHLORIDE, RANITIDINE HYDROCHLORIDE RANITIDINE HYDROCHLORIDE, RANITIDINE HYDROCHLORIDE (OTC) RISPERIDONE, RISPERIDONE SERTRALINE HYDROCHLORIDE, SERTRALINE HYDROCHLORIDE SIMVASTATIN, SIMVASTATIN TRANDOLAPRIL, TRANDOLAPRIL VENLAFAXINE HYDROCHLORIDE, VENLAFAXINE HYDROCHLORIDE ZOLPIDEM TARTRATE, ZOLPIDEM TARTRATE
ZONISAMIDE, ZONISAMIDE
DRAXIMAGE * DRAXIMAGE INC DRAXIMAGE MDP-10, TECHNETIUM TC-99M MEDRONATE KIT DTPA, TECHNETIUM TC-99M PENTETATE KIT HICON, SODIUM IODIDE I-131 TECHNETIUM TC 99M ALBUMIN AGGREGATED KIT, TECHNETIUM TC-99M ALBUMIN AGGREGATED KIT TECHNETIUM TC 99M SESTAMIBI, TECHNETIUM TC-99M SESTAMIBI KIT

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APPENDIX B

PRODUCT NAME SORTED BY APPLICANT


** D **

DURAMED * DURAMED PHARMACEUTICALS INC CENESTIN, ESTROGENS, CONJUGATED SYNTHETIC A ENJUVIA, ESTROGENS, CONJUGATED SYNTHETIC B LOSEASONIQUE, ETHINYL ESTRADIOL MIRCETTE, DESOGESTREL NORDETTE-28, ETHINYL ESTRADIOL PLAN B ONE-STEP, LEVONORGESTREL PLAN B ONE-STEP, LEVONORGESTREL (OTC) PLAN B, LEVONORGESTREL PLAN B, LEVONORGESTREL (OTC)
REVIA, NALTREXONE HYDROCHLORIDE
DURAMED PHARMS BARR * DURAMED PHARMACEUTICALS INC SUB BARR LABORATORIES INC ACETAMINOPHEN AND CODEINE PHOSPHATE, ACETAMINOPHEN AVIANE-28, ETHINYL ESTRADIOL CRYSELLE, ETHINYL ESTRADIOL DESOGESTREL AND ETHINYL ESTRADIOL, DESOGESTREL DIAMOX, ACETAZOLAMIDE DIAMOX, ACETAZOLAMIDE SODIUM ENPRESSE-28, ETHINYL ESTRADIOL METHYLPREDNISOLONE, METHYLPREDNISOLONE OXYCODONE AND ACETAMINOPHEN, ACETAMINOPHEN TRIAMTERENE AND HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE VELIVET, DESOGESTREL ZEBETA, BISOPROLOL FUMARATE
ZIAC, BISOPROLOL FUMARATE
DURAMED RES * DURAMED RESEARCH INC ADDERALL 10, AMPHETAMINE ASPARTATE ADDERALL 12.5, AMPHETAMINE ASPARTATE ADDERALL 15, AMPHETAMINE ASPARTATE ADDERALL 20, AMPHETAMINE ASPARTATE ADDERALL 30, AMPHETAMINE ASPARTATE ADDERALL 5, AMPHETAMINE ASPARTATE ADDERALL 7.5, AMPHETAMINE ASPARTATE AYGESTIN, NORETHINDRONE ACETATE PARAGARD T 380A, COPPER PREFEST, ESTRADIOL SEASONALE, ETHINYL ESTRADIOL SEASONIQUE, ETHINYL ESTRADIOL
SYNTHETIC CONJUGATED ESTROGENS A, ESTROGENS, CONJUGATED SYNTHETIC A
DUSA * DUSA PHARMACEUTICALS INC LEVULAN, AMINOLEVULINIC ACID HYDROCHLORIDE E5 PHARMA INC * E5 PHARMA INC ACETAMINOPHEN, CAFFEINE, AND DIHYDROCODEINE BITARTRATE, EASTMAN KODAK * EASTMAN KODAK CO LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE, EBEWE PARENTA * EBEWE PARENTA PHARMACEUTICALS INC MIVACURIUM CHLORIDE, MIVACURIUM CHLORIDE EBEWE PHARMA * EBEWE PHARMA GRANISETRON HYDROCHLORIDE, GRANISETRON HYDROCHLORIDE * EBEWE PHARMA GES MBH NFG KG CARBOPLATIN, CARBOPLATIN EPIRUBICIN HYDROCHLORIDE, EPIRUBICIN HYDROCHLORIDE
FLUDARABINE PHOSPHATE, FLUDARABINE PHOSPHATE

ACETAMINOPHEN

EPINEPHRINE

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APPENDIX B

PRODUCT NAME SORTED BY APPLICANT


** E **

* EBEWE PHARMA GES MBH NFG KG FLUOROURACIL, FLUOROURACIL IRINOTECAN HYDROCHLORIDE, IRINOTECAN HYDROCHLORIDE METHOTREXATE SODIUM PRESERVATIVE FREE, METHOTREXATE SODIUM OXALIPLATIN, OXALIPLATIN PACLITAXEL, PACLITAXEL
VINORELBINE TARTRATE, VINORELBINE TARTRATE
ECOLAB * ECOLAB INC CHG SCRUB, CIDA-STAT,

CHLORHEXIDINE GLUCONATE CHLORHEXIDINE GLUCONATE

(OTC)
(OTC)

ECR * ECR PHARMACEUTICALS DEXAMETHASONE, DEXAMETHASONE EGIS * EGIS PHARMACEUTICALS BUSPIRONE HYDROCHLORIDE,

BUSPIRONE HYDROCHLORIDE

EISAI INC * EISAI INC ACIPHEX, RABEPRAZOLE SODIUM ARICEPT ODT, DONEPEZIL HYDROCHLORIDE ARICEPT, DONEPEZIL HYDROCHLORIDE BANZEL, RUFINAMIDE DACOGEN, DECITABINE FRAGMIN, DALTEPARIN SODIUM GLIADEL, CARMUSTINE HEXALEN, ALTRETAMINE LUSEDRA, FOSPROPOFOL DISODIUM PANRETIN, ALITRETINOIN SALAGEN, PILOCARPINE HYDROCHLORIDE TARGRETIN, BEXAROTENE
ZONEGRAN, ZONISAMIDE
EKR THERAP * EKR THERAPEUTICS INC CARDENE IN 0.83% SODIUM CHLORIDE IN PLASTIC CONTAINER, NICARDIPINE HYDROCHLORIDE CARDENE IN 0.86% SODIUM CHLORIDE IN PLASTIC CONTAINER, NICARDIPINE HYDROCHLORIDE CARDENE IN 4.8% DEXTROSE IN PLASTIC CONTAINER, NICARDIPINE HYDROCHLORIDE CARDENE IN 5.0% DEXTROSE IN PLASTIC CONTAINER, NICARDIPINE HYDROCHLORIDE CARDENE SR, NICARDIPINE HYDROCHLORIDE
CARDENE, NICARDIPINE HYDROCHLORIDE
ELAN DRUG * ELAN DRUG DELIVERY INC VERELAN PM, VERAPAMIL HYDROCHLORIDE
VERELAN, VERAPAMIL HYDROCHLORIDE
ELAN PHARM * ELAN PHARMACEUTICAL RESEARCH CORP ISOSORBIDE MONONITRATE, ISOSORBIDE MONONITRATE
KETOPROFEN, KETOPROFEN
ELAN PHARMS * ELAN PHARMACEUTICALS INC PRIALT, ZICONOTIDE ELI LILLY AND CO * ELI LILLY AND CO EFFIENT, PRASUGREL HYDROCHLORIDE ELI LILLY CO * ELI LILLY CO ADCIRCA, TADALAFIL
ZYPREXA RELPREVV, OLANZAPINE PAMOATE

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APPENDIX B

PRODUCT NAME SORTED BY APPLICANT


** E **

ELKINS SINN * ELKINS SINN DIV AH ROBINS CO INC MEPERIDINE HYDROCHLORIDE, MEPERIDINE HYDROCHLORIDE
PANCURONIUM BROMIDE, PANCURONIUM BROMIDE
EMD SERONO * EMD SERONO INC CETROTIDE, CETRORELIX GONAL-F RFF PEN, FOLLITROPIN ALFA/BETA GONAL-F RFF, FOLLITROPIN ALFA/BETA GONAL-F, FOLLITROPIN ALFA/BETA LUVERIS, LUTROPIN ALFA NOVANTRONE, MITOXANTRONE HYDROCHLORIDE OVIDREL, CHORIOGONADOTROPIN ALFA SAIZEN, SOMATROPIN RECOMBINANT SEROPHENE, CLOMIPHENE CITRATE SEROSTIM, SOMATROPIN RECOMBINANT
ZORBTIVE, SOMATROPIN RECOMBINANT
ENDO PHARM * ENDO PHARMACEUTICAL SOLUTIONS INC DELATESTRYL, TESTOSTERONE ENANTHATE SUPPRELIN LA, HISTRELIN ACETATE VALSTAR PRESERVATIVE FREE, VALRUBICIN
VANTAS, HISTRELIN ACETATE
ENDO PHARMS * ENDO PHARMACEUTICALS INC FROVA, FROVATRIPTAN SUCCINATE MOBAN, MOLINDONE HYDROCHLORIDE MORPHINE SULFATE, MORPHINE SULFATE MYCOPHENOLATE MOFETIL, MYCOPHENOLATE MOFETIL OPANA ER, OXYMORPHONE HYDROCHLORIDE OPANA, OXYMORPHONE HYDROCHLORIDE OXYCODONE AND ACETAMINOPHEN, ACETAMINOPHEN PERCOCET, ACETAMINOPHEN PERCODAN, ASPIRIN SYMMETREL, AMANTADINE HYDROCHLORIDE
ZYDONE, ACETAMINOPHEN
ENTURIA INC * ENTURIA INC CHLORAPREP CHLORAPREP CHLORAPREP CHLORAPREP CHLORAPREP

ONE-STEP FREPP, CHLORHEXIDINE GLUCONATE (OTC) ONE-STEP SEPP, CHLORHEXIDINE GLUCONATE (OTC) ONE-STEP, CHLORHEXIDINE GLUCONATE (OTC) SINGLE SWABSTICK, CHLORHEXIDINE GLUCONATE (OTC)
WITH TINT, CHLORHEXIDINE GLUCONATE (OTC)

EPIC PHARMA * EPIC PHARMA LLC SULINDAC, SULINDAC


TRANDOLAPRIL, TRANDOLAPRIL
EURAND * EURAND AMERICA INC POTASSIUM CHLORIDE, * EURAND INC ZENPEP, LIPASE

POTASSIUM CHLORIDE

EUSA PHARMA USA * EUSA PHARMA (USA) INC QUADRAMET, SAMARIUM SM-153 LEXIDRONAM PENTASODIUM EXALENZ BIOSCIENCE * EXALENZ BIOSCIENCE LTD IDKIT:HP, UREA C-13 EXCELLIUM * EXCELLIUM PHARMACEUTICAL INC FOLIC ACID, FOLIC ACID

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APPENDIX B

PRODUCT NAME SORTED BY APPLICANT


** E **

* EXCELLIUM PHARMACEUTICAL INC FUROSEMIDE, FUROSEMIDE HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE


LORAZEPAM, LORAZEPAM
EYETECH INC * EYETECH INC MACUGEN, PEGAPTANIB SODIUM FALCON PHARMS * FALCON PHARMACEUTICALS INC TIMOLOL MALEATE, TIMOLOL MALEATE * FALCON PHARMACEUTICALS LTD DIPIVEFRIN HYDROCHLORIDE, DIPIVEFRIN HYDROCHLORIDE GENTAMICIN SULFATE, GENTAMICIN SULFATE LEVOBUNOLOL HYDROCHLORIDE, LEVOBUNOLOL HYDROCHLORIDE MAXITROL, DEXAMETHASONE METIPRANOLOL, METIPRANOLOL HYDROCHLORIDE TIMOLOL MALEATE, TIMOLOL MALEATE TOBREX, TOBRAMYCIN
TRIMETHOPRIM SULFATE AND POLYMYXIN B SULFATE, POLYMYXIN B SULFATE
FDC LTD * FDC LTD CIPROFLOXACIN HYDROCHLORIDE, CIPROFLOXACIN HYDROCHLORIDE OFLOXACIN, OFLOXACIN
TIMOLOL MALEATE, TIMOLOL MALEATE
FEINSTEIN * FEINSTEIN INSTITUTE MEDICAL RESEARCH AMMONIA N 13, AMMONIA, N-13
FLUDEOXYGLUCOSE F18, FLUDEOXYGLUCOSE F-18
FERNDALE LABS * FERNDALE LABORATORIES INC HYDROCORTISONE ACETATE, HYDROCORTISONE ACETATE MICORT-HC, HYDROCORTISONE ACETATE
PRAMOSONE, HYDROCORTISONE ACETATE
FERRING * FERRING PHARMACEUTICALS INC ACTHREL, CORTICORELIN OVINE TRIFLUTATE BRAVELLE, UROFOLLITROPIN CHORIONIC GONADOTROPIN, GONADOTROPIN, CHORIONIC DESMOPRESSIN ACETATE, DESMOPRESSIN ACETATE ENDOMETRIN, PROGESTERONE FIRMAGON, DEGARELIX ACETATE MENOPUR, LUTEINIZING HORMONE MINIRIN, DESMOPRESSIN ACETATE REPRONEX, LUTEINIZING HORMONE
TEV-TROPIN, SOMATROPIN RECOMBINANT
FLEMING * FLEMING AND CO PHARMACEUTICALS THYROSHIELD, POTASSIUM IODIDE

(OTC)

FOREST LABS * FOREST LABORATORIES INC BYSTOLIC, NEBIVOLOL HYDROCHLORIDE CAMPRAL, ACAMPROSATE CALCIUM CELEXA, CITALOPRAM HYDROBROMIDE COMBUNOX, IBUPROFEN LEXAPRO, ESCITALOPRAM OXALATE NAMENDA, MEMANTINE HYDROCHLORIDE TESSALON, BENZONATATE THYROLAR-0.25, LIOTHYRONINE SODIUM THYROLAR-0.5, LIOTHYRONINE SODIUM THYROLAR-1, LIOTHYRONINE SODIUM THYROLAR-2, LIOTHYRONINE SODIUM
THYROLAR-3, LIOTHYRONINE SODIUM

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APPENDIX B

PRODUCT NAME SORTED BY APPLICANT


** F **

FOUGERA * E FOUGERA DIV ALTANA INC BETAMETHASONE DIPROPIONATE, BETAMETHASONE DIPROPIONATE BETAMETHASONE VALERATE, BETAMETHASONE VALERATE CLINDAMYCIN PHOSPHATE, CLINDAMYCIN PHOSPHATE CLOBETASOL PROPIONATE, CLOBETASOL PROPIONATE ERYTHROMYCIN, ERYTHROMYCIN FLUOCINOLONE ACETONIDE, FLUOCINOLONE ACETONIDE FLUOCINONIDE, FLUOCINONIDE GENTAMICIN SULFATE, GENTAMICIN SULFATE HYDROCORTISONE, HYDROCORTISONE LIDOCAINE, LIDOCAINE NEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONE, DEXAMETHASONE NITROGLYCERIN, NITROGLYCERIN NYSTATIN AND TRIAMCINOLONE ACETONIDE, NYSTATIN
NYSTATIN, NYSTATIN
FRESENIUS * FRESENIUS KABI DEUTSCHLAND GMBH INTRALIPID 10%, SOYBEAN OIL INTRALIPID 20%, SOYBEAN OIL
INTRALIPID 30%, SOYBEAN OIL
* FRESENIUS USA INC INPERSOL-LC/LM W/ DEXTROSE 1.5% IN PLASTIC CONTAINER, CALCIUM CHLORIDE INPERSOL-LC/LM W/ DEXTROSE 2.5% IN PLASTIC CONTAINER, CALCIUM CHLORIDE INPERSOL-LC/LM W/ DEXTROSE 3.5% IN PLASTIC CONTAINER, CALCIUM CHLORIDE
INPERSOL-LC/LM W/ DEXTROSE 4.25% IN PLASTIC CONTAINER, CALCIUM CHLORIDE
FRESENIUS KABI ONCOL * FRESENIUS KABI ONCOLOGY PLC CARBOPLATIN, CARBOPLATIN EPIRUBICIN HYDROCHLORIDE, EPIRUBICIN HYDROCHLORIDE IRINOTECAN HYDROCHLORIDE, IRINOTECAN HYDROCHLORIDE MITOXANTRONE HYDROCHLORIDE, MITOXANTRONE HYDROCHLORIDE OXALIPLATIN, OXALIPLATIN
PACLITAXEL, PACLITAXEL
FRESENIUS MEDCL * FRESENIUS MEDICAL CARE NORTH AMERICA CALCITRIOL, CALCITRIOL DELFLEX W/ DEXTROSE 1.5% IN PLASTIC CONTAINER, CALCIUM CHLORIDE DELFLEX W/ DEXTROSE 1.5% LOW MAGNESIUM IN PLASTIC CONTAINER, CALCIUM CHLORIDE DELFLEX W/ DEXTROSE 1.5% LOW MAGNESIUM LOW CALCIUM IN PLASTIC CONTAINER, CALCIUM CHLORIDE DELFLEX W/ DEXTROSE 2.5% IN PLASTIC CONTAINER, CALCIUM CHLORIDE DELFLEX W/ DEXTROSE 2.5% LOW MAGNESIUM IN PLASTIC CONTAINER, CALCIUM CHLORIDE DELFLEX W/ DEXTROSE 2.5% LOW MAGNESIUM LOW CALCIUM IN PLASTIC CONTAINER, CALCIUM CHLORIDE DELFLEX W/ DEXTROSE 3.5% IN PLASTIC CONTAINER, CALCIUM CHLORIDE DELFLEX W/ DEXTROSE 4.25% IN PLASTIC CONTAINER, CALCIUM CHLORIDE DELFLEX W/ DEXTROSE 4.25% LOW MAGNESIUM IN PLASTIC CONTAINER, CALCIUM CHLORIDE DELFLEX W/ DEXTROSE 4.25% LOW MAGNESIUM LOW CALCIUM IN PLASTIC CONTAINER, CALCIUM CHLORIDE DELFLEX-LM W/ DEXTROSE 1.5% IN PLASTIC CONTAINER, CALCIUM CHLORIDE
DELFLEX-LM W/ DEXTROSE 2.5% IN PLASTIC CONTAINER, CALCIUM CHLORIDE
DELFLEX-LM W/ DEXTROSE 3.5% IN PLASTIC CONTAINER, CALCIUM CHLORIDE
DELFLEX-LM W/ DEXTROSE 4.25% IN PLASTIC CONTAINER, CALCIUM CHLORIDE
PHOSLO GELCAPS, CALCIUM ACETATE
SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, SODIUM CHLORIDE
FSC * FSC LABORATORIES INC PRIMSOL, TRIMETHOPRIM HYDROCHLORIDE FUTURE PAK * FUTURE PAK LTD K+10, POTASSIUM CHLORIDE

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APPENDIX B

PRODUCT NAME SORTED BY APPLICANT


** G **

G AND W LABS * G AND W LABORATORIES INC ACEPHEN, ACETAMINOPHEN (OTC) CICLOPIROX, CICLOPIROX FLUTICASONE PROPIONATE, FLUTICASONE PROPIONATE HALOBETASOL PROPIONATE, HALOBETASOL PROPIONATE INDOMETHACIN, INDOMETHACIN METRONIDAZOLE, METRONIDAZOLE MICONAZOLE 7 COMBINATION PACK, MICONAZOLE NITRATE (OTC) MICONAZOLE NITRATE, MICONAZOLE NITRATE (OTC) MIGERGOT, CAFFEINE MOMETASONE FUROATE, MOMETASONE FUROATE PROCHLORPERAZINE, PROCHLORPERAZINE PROMETHAZINE HYDROCHLORIDE, PROMETHAZINE HYDROCHLORIDE PROMETHEGAN, PROMETHAZINE HYDROCHLORIDE
TRIAMCINOLONE ACETONIDE, TRIAMCINOLONE ACETONIDE
GALDERMA LABS * GALDERMA LABORATORIES INC CLOBEX, CLOBETASOL PROPIONATE
EPIDUO, ADAPALENE
GALDERMA LABS LP * GALDERMA LABORATORIES L P CLOBEX, CLOBETASOL PROPIONATE * GALDERMA LABORATORIES LP CAPEX, FLUOCINOLONE ACETONIDE CLINDAGEL, CLINDAMYCIN PHOSPHATE CLOBEX, CLOBETASOL PROPIONATE DESOWEN, DESONIDE DIFFERIN, ADAPALENE LIDOCAINE AND TETRACAINE, LIDOCAINE METROCREAM, METRONIDAZOLE METROGEL, METRONIDAZOLE METROLOTION, METRONIDAZOLE METVIXIA, METHYL AMINOLEVULINATE HYDROCHLORIDE ORACEA, DOXYCYCLINE PERIOSTAT, DOXYCYCLINE HYCLATE TRI-LUMA, FLUOCINOLONE ACETONIDE
VECTICAL, CALCITRIOL
GALDERMA R AND D * GALDERMA RESEARCH AND DEVELOPMENT INC DIFFERIN, ADAPALENE GALEN LTD * GALEN LTD FEMRING,

ESTRADIOL ACETATE

GAMBRO RENAL PRODS * GAMBRO RENAL PRODUCTS PRISMASOL B22GK 2/0 IN PLASTIC CONTAINER, CALCIUM CHLORIDE PRISMASOL B22GK 4/0 IN PLASTIC CONTAINER, CALCIUM CHLORIDE PRISMASOL B22GK 4/2.5 IN PLASTIC CONTAINER, CALCIUM CHLORIDE PRISMASOL BGK 0/2.5 IN PLASTIC CONTAINER, CALCIUM CHLORIDE PRISMASOL BGK 2/0 IN PLASTIC CONTAINER, CALCIUM CHLORIDE PRISMASOL BGK 2/3.5 IN PLASTIC CONTAINER, CALCIUM CHLORIDE PRISMASOL BGK 4/0/1.2 IN PLASTIC CONTAINER, CALCIUM CHLORIDE PRISMASOL BGK 4/2.5 IN PLASTIC CONTAINER, CALCIUM CHLORIDE PRISMASOL BK 0/0/1.2 IN PLASTIC CONTAINER, CALCIUM CHLORIDE
PRISMASOL BK 0/3.5 IN PLASTIC CONTAINER, CALCIUM CHLORIDE
GAVIS PHARMS * GAVIS PHARMACEUTICALS LLC NYSTATIN, NYSTATIN
ORPHENADRINE CITRATE, ORPHENADRINE CITRATE

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APPENDIX B
GD SEARLE * GD SEARLE LLC CELEBREX, CELECOXIB
DAYPRO, OXAPROZIN

PRODUCT NAME SORTED BY APPLICANT


** G **

GD SEARLE LLC * GD SEARLE LLC ALDACTAZIDE, HYDROCHLOROTHIAZIDE ALDACTONE, SPIRONOLACTONE ARTHROTEC, DICLOFENAC SODIUM CALAN, VERAPAMIL HYDROCHLORIDE COVERA-HS, VERAPAMIL HYDROCHLORIDE CYTOTEC, MISOPROSTOL FLAGYL ER, METRONIDAZOLE FLAGYL I.V. RTU IN PLASTIC CONTAINER, METRONIDAZOLE FLAGYL I.V., METRONIDAZOLE HYDROCHLORIDE FLAGYL, METRONIDAZOLE INSPRA, EPLERENONE LOMOTIL, ATROPINE SULFATE NORPACE CR, DISOPYRAMIDE PHOSPHATE NORPACE, DISOPYRAMIDE PHOSPHATE
SYNAREL, NAFARELIN ACETATE
GE HEALTHCARE * GE HEALTHCARE ADREVIEW, IOBENGUANE SULFATE I-123 CERETEC, TECHNETIUM TC-99M EXAMETAZIME KIT HYPAQUE, DIATRIZOATE SODIUM INDICLOR, INDIUM IN-111 CHLORIDE INDIUM IN-111 OXYQUINOLINE, INDIUM IN-111 OXYQUINOLINE METASTRON, STRONTIUM CHLORIDE SR-89 MPI DMSA KIDNEY REAGENT, TECHNETIUM TC-99M SUCCIMER KIT MPI INDIUM DTPA IN 111, INDIUM IN-111 PENTETATE DISODIUM MYOVIEW 30ML, TECHNETIUM TC-99M TETROFOSMIN KIT MYOVIEW, TECHNETIUM TC-99M TETROFOSMIN KIT OMNIPAQUE 140, IOHEXOL OMNIPAQUE 180, IOHEXOL OMNIPAQUE 240, IOHEXOL OMNIPAQUE 300, IOHEXOL OMNIPAQUE 350, IOHEXOL OMNISCAN, GADODIAMIDE OPTISON, ALBUMIN HUMAN SODIUM IODIDE I 123, SODIUM IODIDE I-123 TECHNETIUM TC-99M PENTETATE KIT, TECHNETIUM TC-99M PENTETATE KIT THALLOUS CHLORIDE TL 201, THALLOUS CHLORIDE TL-201 VISIPAQUE 270, IODIXANOL
VISIPAQUE 320, IODIXANOL
GEDEON RICHTER USA * GEDEON RICHTER USA INC AMLODIPINE BESYLATE, AMLODIPINE BESYLATE FINASTERIDE, FINASTERIDE
TERBINAFINE HYDROCHLORIDE, TERBINAFINE HYDROCHLORIDE
GENENTECH * GENENTECH INC NUTROPIN AQ PEN, SOMATROPIN RECOMBINANT NUTROPIN AQ, SOMATROPIN RECOMBINANT
NUTROPIN, SOMATROPIN RECOMBINANT
GENERA PHARMS * GENERA PHARMACEUTICALS LLC CROMOLYN SODIUM, CROMOLYN SODIUM GENERAMEDIX * GENERAMEDIX INC AZITHROMYCIN, AZITHROMYCIN
PAMIDRONATE DISODIUM, PAMIDRONATE DISODIUM

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APPENDIX B
GENIX THERAP * GENIX THERAPEUTICS INC CALCITRIOL, CALCITRIOL

PRODUCT NAME SORTED BY APPLICANT


** G **

GENPHARM * GENPHARM INC ACYCLOVIR, ACYCLOVIR AMNESTEEM, ISOTRETINOIN BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE, BENAZEPRIL HYDROCHLORIDE ENALAPRIL MALEATE, ENALAPRIL MALEATE FAMOTIDINE, FAMOTIDINE FAMOTIDINE, FAMOTIDINE (OTC) FLUCONAZOLE, FLUCONAZOLE FLUTAMIDE, FLUTAMIDE GLIMEPIRIDE, GLIMEPIRIDE MELOXICAM, MELOXICAM METFORMIN HYDROCHLORIDE, METFORMIN HYDROCHLORIDE NIZATIDINE, NIZATIDINE OXAPROZIN, OXAPROZIN QUINAPRIL HYDROCHLORIDE, QUINAPRIL HYDROCHLORIDE RANITIDINE HYDROCHLORIDE, RANITIDINE HYDROCHLORIDE RANITIDINE HYDROCHLORIDE, RANITIDINE HYDROCHLORIDE (OTC) SERTRALINE HYDROCHLORIDE, SERTRALINE HYDROCHLORIDE TERBINAFINE HYDROCHLORIDE, TERBINAFINE HYDROCHLORIDE TICLOPIDINE HYDROCHLORIDE, TICLOPIDINE HYDROCHLORIDE
ZOLPIDEM TARTRATE, ZOLPIDEM TARTRATE
* GENPHARM PHARMACEUTICALS INC ATENOLOL, ATENOLOL GENPHARM ULC * GENPHARM ULC ALENDRONATE SODIUM, GENTA * GENTA INC GANITE,

ALENDRONATE SODIUM

GALLIUM NITRATE

GENZYME * GENZYME CORP CEREDASE, ALGLUCERASE CEREZYME, IMIGLUCERASE CLOLAR, CLOFARABINE FLUDARA, FLUDARABINE PHOSPHATE HECTOROL, DOXERCALCIFEROL LEUPROLIDE ACETATE, LEUPROLIDE ACETATE MOZOBIL, PLERIXAFOR RENAGEL, SEVELAMER HYDROCHLORIDE RENVELA, SEVELAMER CARBONATE
THYROGEN, THYROTROPIN ALFA
GILEAD * GILEAD SCIENCES INC ATRIPLA, EFAVIRENZ CAYSTON, AZTREONAM EMTRIVA, EMTRICITABINE HEPSERA, ADEFOVIR DIPIVOXIL LETAIRIS, AMBRISENTAN RANEXA, RANOLAZINE TRUVADA, EMTRICITABINE VIREAD, TENOFOVIR DISOPROXIL FUMARATE
VISTIDE, CIDOFOVIR
GLAND PHARMA LTD * GLAND PHARMA LTD ADENOSINE, ADENOSINE AMIODARONE HYDROCHLORIDE, AMIODARONE HYDROCHLORIDE HALOPERIDOL, HALOPERIDOL LACTATE
MILRINONE LACTATE, MILRINONE LACTATE

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APPENDIX B
* GLAND PHARMA LTD ONDANSETRON HYDROCHLORIDE,

PRODUCT NAME SORTED BY APPLICANT


** G **
ONDANSETRON HYDROCHLORIDE

GLAXO GRP LTD * GLAXO GROUP LTD DBA GLAXOSMITHKLINE ALTABAX, RETAPAMULIN FLOVENT HFA, FLUTICASONE PROPIONATE
SEREVENT, SALMETEROL XINAFOATE
GLAXOSMITHKLINE * GLAXOSMITHKLINE ABREVA, DOCOSANOL (OTC) ACLOVATE, ALCLOMETASONE DIPROPIONATE ADVAIR DISKUS 100/50, FLUTICASONE PROPIONATE ADVAIR DISKUS 250/50, FLUTICASONE PROPIONATE ADVAIR DISKUS 500/50, FLUTICASONE PROPIONATE ADVAIR HFA, FLUTICASONE PROPIONATE AGENERASE, AMPRENAVIR ALBENZA, ALBENDAZOLE ALKERAN, MELPHALAN ALKERAN, MELPHALAN HYDROCHLORIDE AMERGE, NARATRIPTAN HYDROCHLORIDE ARIXTRA, FONDAPARINUX SODIUM AUGMENTIN '125', AMOXICILLIN AUGMENTIN '250', AMOXICILLIN AUGMENTIN '500', AMOXICILLIN AUGMENTIN '875', AMOXICILLIN AUGMENTIN XR, AMOXICILLIN AVODART, DUTASTERIDE BACTROBAN, MUPIROCIN BACTROBAN, MUPIROCIN CALCIUM BECONASE AQ, BECLOMETHASONE DIPROPIONATE MONOHYDRATE CEFTIN, CEFUROXIME AXETIL DARAPRIM, PYRIMETHAMINE DYAZIDE, HYDROCHLOROTHIAZIDE EPIVIR-HBV, LAMIVUDINE FLOLAN, EPOPROSTENOL SODIUM FLONASE, FLUTICASONE PROPIONATE FLOVENT DISKUS 100, FLUTICASONE PROPIONATE FLOVENT DISKUS 250, FLUTICASONE PROPIONATE FLOVENT DISKUS 50, FLUTICASONE PROPIONATE FORTAZ IN PLASTIC CONTAINER, CEFTAZIDIME SODIUM FORTAZ, CEFTAZIDIME HYCAMTIN, TOPOTECAN HYDROCHLORIDE IMITREX STATDOSE, SUMATRIPTAN SUCCINATE IMITREX, SUMATRIPTAN IMITREX, SUMATRIPTAN SUCCINATE LAMICTAL CD, LAMOTRIGINE LAMICTAL, LAMOTRIGINE LANOXIN PEDIATRIC, DIGOXIN LANOXIN, DIGOXIN LAROTID, AMOXICILLIN MALARONE PEDIATRIC, ATOVAQUONE MALARONE, ATOVAQUONE MEPRON, ATOVAQUONE MYLERAN, BUSULFAN NICORETTE (MINT), NICOTINE POLACRILEX (OTC) NICORETTE, NICOTINE POLACRILEX (OTC) PARNATE, TRANYLCYPROMINE SULFATE PAXIL CR, PAROXETINE HYDROCHLORIDE PAXIL, PAROXETINE HYDROCHLORIDE PROMACTA, ELTROMBOPAG OLAMINE RELENZA, ZANAMIVIR REQUIP, ROPINIROLE HYDROCHLORIDE TAGAMET HB, CIMETIDINE (OTC)
TAGAMET, CIMETIDINE

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APPENDIX B

PRODUCT NAME SORTED BY APPLICANT


** G **

* GLAXOSMITHKLINE THIOGUANINE, THIOGUANINE TIMENTIN IN PLASTIC CONTAINER, CLAVULANATE POTASSIUM TIMENTIN, CLAVULANATE POTASSIUM TREXIMET, NAPROXEN SODIUM VALTREX, VALACYCLOVIR HYDROCHLORIDE VENTOLIN HFA, ALBUTEROL SULFATE VERAMYST, FLUTICASONE FUROATE VOTRIENT, PAZOPANIB HYDROCHLORIDE WELLBUTRIN SR, BUPROPION HYDROCHLORIDE WELLBUTRIN, BUPROPION HYDROCHLORIDE ZANTAC 150, RANITIDINE HYDROCHLORIDE ZANTAC 25, RANITIDINE HYDROCHLORIDE ZANTAC 300, RANITIDINE HYDROCHLORIDE ZANTAC IN PLASTIC CONTAINER, RANITIDINE HYDROCHLORIDE ZANTAC, RANITIDINE HYDROCHLORIDE ZINACEF IN PLASTIC CONTAINER, CEFUROXIME SODIUM ZINACEF, CEFUROXIME SODIUM ZOFRAN AND DEXTROSE IN PLASTIC CONTAINER, ONDANSETRON HYDROCHLORIDE ZOFRAN ODT, ONDANSETRON ZOFRAN PRESERVATIVE FREE, ONDANSETRON HYDROCHLORIDE ZOFRAN, ONDANSETRON HYDROCHLORIDE ZOVIRAX, ACYCLOVIR ZOVIRAX, ACYCLOVIR SODIUM
ZYBAN, BUPROPION HYDROCHLORIDE
GLAXOSMITHKLINE CONS * GLAXOSMITHKLINE CONSUMER HEALTHCARE ALLI, ORLISTAT (OTC) COMMIT, NICOTINE POLACRILEX (OTC)
NICORETTE, NICOTINE POLACRILEX (OTC)
GLENMARK GENERICS * GLENMARK GENERICS INC USA BETAMETHASONE DIPROPIONATE, BETAMETHASONE DIPROPIONATE CALCIPOTRIENE, CALCIPOTRIENE DIPYRIDAMOLE, DIPYRIDAMOLE MOMETASONE FUROATE, MOMETASONE FUROATE NILSTAT, NYSTATIN RANITIDINE HYDROCHLORIDE, RANITIDINE HYDROCHLORIDE
ZONISAMIDE, ZONISAMIDE
* GLENMARK GENERICS LTD ALCLOMETASONE DIPROPIONATE, ALCLOMETASONE DIPROPIONATE AMLODIPINE BESYLATE, AMLODIPINE BESYLATE CARVEDILOL, CARVEDILOL CITALOPRAM HYDROBROMIDE, CITALOPRAM HYDROBROMIDE FLUCONAZOLE, FLUCONAZOLE GABAPENTIN, GABAPENTIN LAMOTRIGINE, LAMOTRIGINE LITHIUM CARBONATE, LITHIUM CARBONATE MELOXICAM, MELOXICAM METFORMIN HYDROCHLORIDE, METFORMIN HYDROCHLORIDE MOEXIPRIL HYDROCHLORIDE, MOEXIPRIL HYDROCHLORIDE NAPROXEN SODIUM, NAPROXEN SODIUM NAPROXEN, NAPROXEN ONDANSETRON HYDROCHLORIDE, ONDANSETRON HYDROCHLORIDE ONDANSETRON, ONDANSETRON OXCARBAZEPINE, OXCARBAZEPINE PRAVASTATIN SODIUM, PRAVASTATIN SODIUM ROPINIROLE HYDROCHLORIDE, ROPINIROLE HYDROCHLORIDE TERBINAFINE HYDROCHLORIDE, TERBINAFINE HYDROCHLORIDE TOPIRAMATE, TOPIRAMATE
VERAPAMIL HYDROCHLORIDE, VERAPAMIL HYDROCHLORIDE
GLENMARK PHARMS * GLENMARK PHARMACEUTICALS INC USA CICLOPIROX, CICLOPIROX

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APPENDIX B

PRODUCT NAME SORTED BY APPLICANT


** G **
HYDROCHLOROTHIAZIDE

* GLENMARK PHARMACEUTICALS LTD MOEXIPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE, GLENMARK PHARMS LTD * GLENMARK PHARMACEUTICALS LTD HYDRALAZINE HYDROCHLORIDE,

HYDRALAZINE HYDROCHLORIDE

GLOUCESTER PHARMS * GLOUCESTER PHARMACEUTICALS INC ISTODAX, ROMIDEPSIN GRACEWAY * GRACEWAY PHARMACEUTICALS LLC ALDARA, IMIQUIMOD CALCIUM DISODIUM VERSENATE, EDETATE CALCIUM DISODIUM ESTRASORB, ESTRADIOL HEMIHYDRATE MAXAIR, PIRBUTEROL ACETATE METROGEL-VAGINAL, METRONIDAZOLE MINITRAN, NITROGLYCERIN NORFLEX, ORPHENADRINE CITRATE NORGESIC FORTE, ASPIRIN NORGESIC, ASPIRIN TAMBOCOR, FLECAINIDE ACETATE THEOLAIR, THEOPHYLLINE
ZYCLARA, IMIQUIMOD
GRIFFEN * KW GRIFFEN CO BIOSCRUB, CHLORHEXIDINE GLUCONATE GTX INC * GTX INC FARESTON,

(OTC)

TOREMIFENE CITRATE

GUARDIAN DRUG * GUARDIAN DRUG CO INC FOAMCOAT, ALUMINUM HYDROXIDE GUERBET * GUERBET LLC HEXABRIX, IOXAGLATE MEGLUMINE OXILAN-300, IOXILAN
OXILAN-350, IOXILAN

(OTC)

HAEMONETICS * HAEMONETICS CORP SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, HALOCARBON PRODS * HALOCARBON PRODUCTS CORP ISOFLURANE, ISOFLURANE
SEVOFLURANE, SEVOFLURANE

SODIUM CHLORIDE

HALOZYME THERAP * HALOZYME THERAPEUTICS INC HYLENEX RECOMBINANT, HYALURONIDASE RECOMBINANT HUMAN HAMELN PHARMS * HAMELN PHARMACEUTICALS GMBH PENTETATE CALCIUM TRISODIUM, PENTETATE CALCIUM TRISODIUM
PENTETATE ZINC TRISODIUM, PENTETATE ZINC TRISODIUM
HAMPTON LAINE LLC * HAMPTON LAINE LLC FLAVOXATE HYDROCHLORIDE,

FLAVOXATE HYDROCHLORIDE

HANFORD GC * GC HANFORD MANUFACTURING CO AMPICILLIN AND SULBACTAM, AMPICILLIN SODIUM AMPICILLIN SODIUM, AMPICILLIN SODIUM CEFAZOLIN SODIUM, CEFAZOLIN SODIUM CEFTRIAXONE, CEFTRIAXONE SODIUM
CEFUROXIME SODIUM, CEFUROXIME SODIUM

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APPENDIX B

PRODUCT NAME SORTED BY APPLICANT


** H **

* GC HANFORD MANUFACTURING CO PENICILLIN G POTASSIUM, PENICILLIN G POTASSIUM HARMONY LABS * HARMONY LABORATORIES THEROXIDIL, MINOXIDIL

(OTC)

HARRIS PHARM * HARRIS PHARMACEUTICAL INC TERBINAFINE HYDROCHLORIDE,

TERBINAFINE HYDROCHLORIDE

HELSINN HLTHCARE * HELSINN HEALTHCARE SA ALOXI, PALONOSETRON HYDROCHLORIDE HEMOPHARM USA * HEMOPHARM USA CORP A-METHAPRED, METHYLPREDNISOLONE SODIUM SUCCINATE HERCON LABS * HERCON LABORATORIES CORP NITROGLYCERIN, NITROGLYCERIN HERITAGE PHARMS INC * HERITAGE PHARMACEUTICALS INC DOLENE, PROPOXYPHENE HYDROCHLORIDE HYDRALAZINE HYDROCHLORIDE, HYDRALAZINE HYDROCHLORIDE HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE KETOPROFEN, KETOPROFEN LEFLUNOMIDE, LEFLUNOMIDE
PAROMOMYCIN SULFATE, PAROMOMYCIN SULFATE
HETERO DRUGS * HETERO DRUGS LTD METHOCARBAMOL, METHOCARBAMOL STAVUDINE, STAVUDINE
TORSEMIDE, TORSEMIDE
HETERO DRUGS LTD * HETERO DRUGS LTD UNIT III HYDRALAZINE HYDROCHLORIDE, HYDRALAZINE HYDROCHLORIDE HYDROXYZINE HYDROCHLORIDE, HYDROXYZINE HYDROCHLORIDE LITHIUM CARBONATE, LITHIUM CARBONATE
ZIDOVUDINE, ZIDOVUDINE
HEYL CHEMISCH * HEYL CHEMISCH PHARMAZEUTISHE FABRIK RADIOGARDASE (PRUSSIAN BLUE), FERRIC HEXACYANOFERRATE(II) HI TECH PHARMA * HI TECH PHARMACAL CO INC ACETAMINOPHEN AND CODEINE PHOSPHATE, ACETAMINOPHEN ACYCLOVIR, ACYCLOVIR ALBUTEROL SULFATE, ALBUTEROL SULFATE AMANTADINE HYDROCHLORIDE, AMANTADINE HYDROCHLORIDE CALCIPOTRIENE, CALCIPOTRIENE CHLORHEXIDINE GLUCONATE, CHLORHEXIDINE GLUCONATE CICLOPIROX, CICLOPIROX CIMETIDINE HYDROCHLORIDE, CIMETIDINE HYDROCHLORIDE CORMAX, CLOBETASOL PROPIONATE DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE, DORZOLAMIDE HYDROCHLORIDE DORZOLAMIDE HYDROCHLORIDE, DORZOLAMIDE HYDROCHLORIDE EMBELINE E, CLOBETASOL PROPIONATE EMBELINE, CLOBETASOL PROPIONATE ERYTHRO-STATIN, ERYTHROMYCIN FLUTICASONE PROPIONATE, FLUTICASONE PROPIONATE HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE, HOMATROPINE METHYLBROMIDE HYDROXYZINE HYDROCHLORIDE, HYDROXYZINE HYDROCHLORIDE LACTULOSE, LACTULOSE LEVOCARNITINE, LEVOCARNITINE
LIDOCAINE AND PRILOCAINE, LIDOCAINE

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APPENDIX B
*

PRODUCT NAME SORTED BY APPLICANT


** H **

HI TECH PHARMACAL CO INC LIDOCAINE HYDROCHLORIDE, LIDOCAINE HYDROCHLORIDE LOPERAMIDE HYDROCHLORIDE, LOPERAMIDE HYDROCHLORIDE (OTC) MIDAZOLAM HYDROCHLORIDE, MIDAZOLAM HYDROCHLORIDE MINOXIDIL (FOR MEN), MINOXIDIL (OTC) MINOXIDIL (FOR WOMEN), MINOXIDIL (OTC) OFLOXACIN, OFLOXACIN PREDNISOLONE SODIUM PHOSPHATE, PREDNISOLONE SODIUM PHOSPHATE PREDNISOLONE, PREDNISOLONE PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE, CODEINE PHOSPHATE PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE, DEXTROMETHORPHAN HYDROBROMIDE PROMETHAZINE HYDROCHLORIDE, PROMETHAZINE HYDROCHLORIDE
SULFAMETHOXAZOLE AND TRIMETHOPRIM, SULFAMETHOXAZOLE
TIMOLOL MALEATE, TIMOLOL MALEATE
VOSOL HC, ACETIC ACID, GLACIAL
VOSOL, ACETIC ACID, GLACIAL

HIGH TECH PHARMA * HIGH TECHNOLOGY PHARMACAL CO INC VALPROIC ACID, VALPROIC ACID HIKMA * HIKMA FARMACEUTICA LDA CEFOTAXIME, CEFOTAXIME SODIUM * HIKMA PHARMACEUTICALS AMOXICILLIN, AMOXICILLIN CARVEDILOL, CARVEDILOL CEFACLOR, CEFACLOR CEFADROXIL, CEFADROXIL/CEFADROXIL HEMIHYDRATE CEPHALEXIN, CEPHALEXIN CIPROFLOXACIN HYDROCHLORIDE, CIPROFLOXACIN HYDROCHLORIDE GABAPENTIN, GABAPENTIN GLYBURIDE (MICRONIZED), GLYBURIDE NAPROXEN SODIUM, NAPROXEN SODIUM
ZOLPIDEM TARTRATE, ZOLPIDEM TARTRATE
HIKMA FARMACEUTICA * HIKMA FARMACEUTICA (PORTUGAL) SA AMIODARONE HYDROCHLORIDE, AMIODARONE HYDROCHLORIDE BENZTROPINE MESYLATE, BENZTROPINE MESYLATE BUTORPHANOL TARTRATE, BUTORPHANOL TARTRATE CEFOXITIN, CEFOXITIN SODIUM CEFTRIAXONE, CEFTRIAXONE SODIUM CIPROFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER, CIPROFLOXACIN ENALAPRILAT, ENALAPRILAT FLUMAZENIL, FLUMAZENIL FOSPHENYTOIN SODIUM, FOSPHENYTOIN SODIUM GRANISTERON HYDROCHLORIDE, GRANISETRON HYDROCHLORIDE METOPROLOL TARTRATE, METOPROLOL TARTRATE MILRINONE LACTATE IN PLASTIC CONTAINER, MILRINONE LACTATE ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE, ONDANSETRON HYDROCHLORIDE ONDANSETRON HYDROCHLORIDE, ONDANSETRON HYDROCHLORIDE PHENYTOIN SODIUM, PHENYTOIN SODIUM PROMETHAZINE HYDROCHLORIDE, PROMETHAZINE HYDROCHLORIDE PROPRANOLOL HYDROCHLORIDE, PROPRANOLOL HYDROCHLORIDE TERBUTALINE SULFATE, TERBUTALINE SULFATE
VALPROATE SODIUM, VALPROATE SODIUM
* HIKMA FARMACEUTICA PORTUGAL LDA CEFAZOLIN SODIUM, CEFAZOLIN SODIUM CEFUROXIME SODIUM, CEFUROXIME SODIUM
FLUCONAZOLE IN SODIUM CHLORIDE 0.9%, FLUCONAZOLE
* HIKMA FARMACEUTICA SA BUTORPHANOL TARTRATE, BUTORPHANOL TARTRATE HIKMA PHARMS * HIKMA PHARMACEUTICALS AMOXICILLIN AND CLAVULANATE POTASSIUM,

AMOXICILLIN

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APPENDIX B
* HIKMA PHARMACEUTICALS AMOXICILLIN, AMOXICILLIN CEPHALEXIN, CEPHALEXIN
SERTRALINE HYDROCHLORIDE,

PRODUCT NAME SORTED BY APPLICANT


** H **

SERTRALINE HYDROCHLORIDE

HILL DERMAC * HILL DERMACEUTICALS INC DERMA-SMOOTHE/FS, FLUOCINOLONE ACETONIDE


DERMOTIC, FLUOCINOLONE ACETONIDE
HISAMITSU * HISAMITSU PHARMACEUTICAL CO INC SALONPAS, MENTHOL (OTC) HITECH PHARMA * HITECH PHARMACAL CORP CIPROFLOXACIN HYDROCHLORIDE, HOFFMANN LA ROCHE * HOFFMANN LA ROCHE INC INVIRASE, SAQUINAVIR MESYLATE ROCEPHIN, CEFTRIAXONE SODIUM ROMAZICON, FLUMAZENIL XELODA, CAPECITABINE
XENICAL, ORLISTAT
HOLOPACK INTL * HOLOPACK INTERNATIONAL ALBUTEROL SULFATE, ALBUTEROL SULFATE * HOLOPACK INTERNATIONAL CORP IPRATROPIUM BROMIDE, IPRATROPIUM BROMIDE HOSPIRA * HOSPIRA INC ACETIC ACID 0.25% IN PLASTIC CONTAINER, ACETIC ACID, GLACIAL ACETYLCYSTEINE, ACETYLCYSTEINE ACYCLOVIR SODIUM, ACYCLOVIR SODIUM A-HYDROCORT, HYDROCORTISONE SODIUM SUCCINATE ALCOHOL 5% IN D5-W, ALCOHOL ALFENTANIL, ALFENTANIL HYDROCHLORIDE A-METHAPRED, METHYLPREDNISOLONE SODIUM SUCCINATE AMIDATE, ETOMIDATE AMIKACIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, AMIKACIN SULFATE AMIKACIN SULFATE, AMIKACIN SULFATE AMINOCAPROIC ACID IN PLASTIC CONTAINER, AMINOCAPROIC ACID AMINOPHYLLINE, AMINOPHYLLINE AMINOSYN 10% (PH6), AMINO ACIDS AMINOSYN 10%, AMINO ACIDS AMINOSYN 3.5% M, AMINO ACIDS AMINOSYN 3.5%, AMINO ACIDS AMINOSYN 5%, AMINO ACIDS AMINOSYN 7% (PH6), AMINO ACIDS AMINOSYN 7% W/ ELECTROLYTES, AMINO ACIDS AMINOSYN 7%, AMINO ACIDS AMINOSYN 8.5% (PH6), AMINO ACIDS AMINOSYN 8.5% W/ ELECTROLYTES, AMINO ACIDS AMINOSYN 8.5%, AMINO ACIDS AMINOSYN II 10% IN PLASTIC CONTAINER, AMINO ACIDS AMINOSYN II 10% W/ ELECTROLYTES, AMINO ACIDS AMINOSYN II 10%, AMINO ACIDS AMINOSYN II 15% IN PLASTIC CONTAINER, AMINO ACIDS AMINOSYN II 3.5% IN DEXTROSE 25% IN PLASTIC CONTAINER, AMINO ACIDS AMINOSYN II 3.5% IN DEXTROSE 5% IN PLASTIC CONTAINER, AMINO ACIDS AMINOSYN II 3.5% M IN DEXTROSE 5% IN PLASTIC CONTAINER, AMINO ACIDS AMINOSYN II 3.5% W/ ELECTROLYTES IN DEXTROSE 25% W/ CALCIUM IN PLASTIC CONTAINER, ACIDS AMINOSYN II 4.25% IN DEXTROSE 10% IN PLASTIC CONTAINER, AMINO ACIDS
AMINOSYN II 4.25% IN DEXTROSE 20% IN PLASTIC CONTAINER, AMINO ACIDS
AMINOSYN II 4.25% IN DEXTROSE 25% IN PLASTIC CONTAINER, AMINO ACIDS

CIPROFLOXACIN HYDROCHLORIDE

AMINO

SEPTEMBER 2010 - APPROVED DRUG PRODUCTS LIST

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APPENDIX B
*

PRODUCT NAME SORTED BY APPLICANT


** H **

HOSPIRA INC AMINOSYN II 4.25% M IN DEXTROSE 10% IN PLASTIC CONTAINER, AMINO ACIDS AMINOSYN II 4.25% W/ ELECTROLYTES IN DEXTROSE 20% W/ CALCIUM IN PLASTIC CONTAINER, AMINO ACIDS AMINOSYN II 4.25% W/ ELECTROLYTES IN DEXTROSE 25% W/ CALCIUM IN PLASTIC CONTAINER, AMINO ACIDS AMINOSYN II 5% IN DEXTROSE 25% IN PLASTIC CONTAINER, AMINO ACIDS AMINOSYN II 7%, AMINO ACIDS AMINOSYN II 8.5% W/ ELECTROLYTES, AMINO ACIDS AMINOSYN II 8.5%, AMINO ACIDS AMINOSYN-HBC 7%, AMINO ACIDS AMINOSYN-HF 8%, AMINO ACIDS AMINOSYN-PF 10%, AMINO ACIDS AMINOSYN-PF 7%, AMINO ACIDS AMINOSYN-RF 5.2%, AMINO ACIDS AMIODARONE HYDROCHLORIDE, AMIODARONE HYDROCHLORIDE AMMONIUM CHLORIDE IN PLASTIC CONTAINER, AMMONIUM CHLORIDE AQUASOL A, VITAMIN A PALMITATE ATROPINE SULFATE ANSYR PLASTIC SYRINGE, ATROPINE SULFATE AZITHROMYCIN, AZITHROMYCIN BACTERIOSTATIC SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, SODIUM CHLORIDE BACTERIOSTATIC WATER FOR INJECTION IN PLASTIC CONTAINER, STERILE WATER FOR INJECTION BLEOMYCIN SULFATE, BLEOMYCIN SULFATE BRETYLIUM TOSYLATE IN DEXTROSE 5% IN PLASTIC CONTAINER, BRETYLIUM TOSYLATE BRETYLIUM TOSYLATE, BRETYLIUM TOSYLATE BUMETANIDE, BUMETANIDE BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE, BUPIVACAINE HYDROCHLORIDE BUPIVACAINE HYDROCHLORIDE W/EPINEPHRINE, BUPIVACAINE HYDROCHLORIDE BUPIVACAINE HYDROCHLORIDE, BUPIVACAINE HYDROCHLORIDE BUPRENORPHINE HYDROCHLORIDE, BUPRENORPHINE HYDROCHLORIDE BUTORPHANOL TARTRATE PRESERVATIVE FREE, BUTORPHANOL TARTRATE CALCIUM CHLORIDE 10% IN PLASTIC CONTAINER, CALCIUM CHLORIDE CARBOCAINE, MEPIVACAINE HYDROCHLORIDE CARBOPLATIN, CARBOPLATIN CHLOROPROCAINE HYDROCHLORIDE, CHLOROPROCAINE HYDROCHLORIDE CHROMIC CHLORIDE IN PLASTIC CONTAINER, CHROMIC CHLORIDE CIMETIDINE HYDROCHLORIDE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, CIMETIDINE HYDROCHLORIDE CIMETIDINE HYDROCHLORIDE, CIMETIDINE HYDROCHLORIDE
CIPROFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER, CIPROFLOXACIN
CIPROFLOXACIN, CIPROFLOXACIN
CLINDAMYCIN PHOSPHATE, CLINDAMYCIN PHOSPHATE
CORLOPAM, FENOLDOPAM MESYLATE
CUPRIC CHLORIDE IN PLASTIC CONTAINER, CUPRIC CHLORIDE
CYTARABINE, CYTARABINE
DACARBAZINE, DACARBAZINE
DEFEROXAMINE MESYLATE, DEFEROXAMINE MESYLATE
DEMEROL, MEPERIDINE HYDROCHLORIDE
DESMOPRESSIN ACETATE, DESMOPRESSIN ACETATE
DEXTROSE 10% IN PLASTIC CONTAINER, DEXTROSE
DEXTROSE 20% IN PLASTIC CONTAINER, DEXTROSE
DEXTROSE 25%, DEXTROSE
DEXTROSE 30% IN PLASTIC CONTAINER, DEXTROSE
DEXTROSE 40% IN PLASTIC CONTAINER, DEXTROSE
DEXTROSE 5% AND LACTATED RINGER'S IN PLASTIC CONTAINER, CALCIUM CHLORIDE
DEXTROSE 5% AND RINGER'S IN PLASTIC CONTAINER, CALCIUM CHLORIDE
DEXTROSE 5% AND SODIUM CHLORIDE 0.225% IN PLASTIC CONTAINER, DEXTROSE
DEXTROSE 5% AND SODIUM CHLORIDE 0.3% IN PLASTIC CONTAINER, DEXTROSE
DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER, DEXTROSE
DEXTROSE 5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, DEXTROSE
DEXTROSE 5% IN PLASTIC CONTAINER, DEXTROSE
DEXTROSE 50% IN PLASTIC CONTAINER, DEXTROSE
DEXTROSE 70% IN PLASTIC CONTAINER, DEXTROSE
DIAZEPAM, DIAZEPAM
DIGOXIN, DIGOXIN

SEPTEMBER 2010 - APPROVED DRUG PRODUCTS LIST

B - 60

APPENDIX B

PRODUCT NAME SORTED BY APPLICANT


** H **

* HOSPIRA INC DILTIAZEM HYDROCHLORIDE, DILTIAZEM HYDROCHLORIDE DIPHENHYDRAMINE HYDROCHLORIDE, DIPHENHYDRAMINE HYDROCHLORIDE DIPYRIDAMOLE, DIPYRIDAMOLE DOBUTAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINER, DOBUTAMINE HYDROCHLORIDE DOBUTAMINE HYDROCHLORIDE IN DEXTROSE 5%, DOBUTAMINE HYDROCHLORIDE DOBUTAMINE HYDROCHLORIDE, DOBUTAMINE HYDROCHLORIDE DOPAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINER, DOPAMINE HYDROCHLORIDE DOPAMINE HYDROCHLORIDE, DOPAMINE HYDROCHLORIDE DROPERIDOL, DROPERIDOL EDROPHONIUM CHLORIDE, EDROPHONIUM CHLORIDE ENALAPRILAT, ENALAPRILAT EPIRUBICIN HYDROCHLORIDE, EPIRUBICIN HYDROCHLORIDE ERYC, ERYTHROMYCIN ERYTHROCIN, ERYTHROMYCIN LACTOBIONATE FAMOTIDINE, FAMOTIDINE FENTANYL CITRATE PRESERVATIVE FREE, FENTANYL CITRATE FENTANYL CITRATE, FENTANYL CITRATE FLUCONAZOLE IN DEXTROSE 5% IN PLASTIC CONTAINER, FLUCONAZOLE FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, FLUCONAZOLE FLUDARABINE PHOSPHATE, FLUDARABINE PHOSPHATE FOSCARNET SODIUM, FOSCARNET SODIUM FOSPHENYTOIN SODIUM, FOSPHENYTOIN SODIUM FUROSEMIDE, FUROSEMIDE GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, GENTAMICIN SULFATE GENTAMICIN SULFATE, GENTAMICIN SULFATE GLYCINE 1.5% IN PLASTIC CONTAINER, GLYCINE HEPARIN SODIUM 1,000 UNITS IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, HEPARIN SODIUM HEPARIN SODIUM 10,000 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINER, HEPARIN SODIUM HEPARIN SODIUM 12,500 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINER, HEPARIN SODIUM HEPARIN SODIUM 12,500 UNITS IN SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER, HEPARIN SODIUM HEPARIN SODIUM 2,000 UNITS IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, HEPARIN SODIUM HEPARIN SODIUM 20,000 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINER, HEPARIN SODIUM HEPARIN SODIUM 25,000 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINER, HEPARIN SODIUM HEPARIN SODIUM 25,000 UNITS IN SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER, HEPARIN SODIUM HEPARIN SODIUM PRESERVATIVE FREE, HEPARIN SODIUM HEPARIN SODIUM, HEPARIN SODIUM HYDROMORPHONE HYDROCHLORIDE, HYDROMORPHONE HYDROCHLORIDE IONOSOL B AND DEXTROSE 5% IN PLASTIC CONTAINER, DEXTROSE IONOSOL MB AND DEXTROSE 5% IN PLASTIC CONTAINER, DEXTROSE IONOSOL T AND DEXTROSE 5% IN PLASTIC CONTAINER, DEXTROSE IOPAMIDOL-200 IN PLASTIC CONTAINER, IOPAMIDOL IOPAMIDOL-200, IOPAMIDOL IOPAMIDOL-250 IN PLASTIC CONTAINER, IOPAMIDOL IOPAMIDOL-250, IOPAMIDOL IOPAMIDOL-300 IN PLASTIC CONTAINER, IOPAMIDOL IOPAMIDOL-300, IOPAMIDOL IOPAMIDOL-370 IN PLASTIC CONTAINER, IOPAMIDOL IOPAMIDOL-370, IOPAMIDOL IRINOTECAN HYDROCHLORIDE, IRINOTECAN HYDROCHLORIDE ISOFLURANE, ISOFLURANE ISUPREL, ISOPROTERENOL HYDROCHLORIDE KETAMINE HYDROCHLORIDE, KETAMINE HYDROCHLORIDE KETOROLAC TROMETHAMINE, KETOROLAC TROMETHAMINE LABETALOL HYDROCHLORIDE, LABETALOL HYDROCHLORIDE LACTATED RINGER'S IN PLASTIC CONTAINER, CALCIUM CHLORIDE LEUCOVORIN CALCIUM, LEUCOVORIN CALCIUM LEVOPHED, NOREPINEPHRINE BITARTRATE LIDOCAINE HYDROCHLORIDE 0.4% IN DEXTROSE 5% IN PLASTIC CONTAINER, LIDOCAINE HYDROCHLORIDE LIDOCAINE HYDROCHLORIDE 0.8% IN DEXTROSE 5% IN PLASTIC CONTAINER, LIDOCAINE HYDROCHLORIDE LIDOCAINE HYDROCHLORIDE 5% AND DEXTROSE 7.5%, LIDOCAINE HYDROCHLORIDE LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE, EPINEPHRINE LIDOCAINE HYDROCHLORIDE IN PLASTIC CONTAINER, LIDOCAINE HYDROCHLORIDE LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE IN PLASTIC CONTAINER, LIDOCAINE HYDROCHLORIDE LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE, LIDOCAINE HYDROCHLORIDE

SEPTEMBER 2010 - APPROVED DRUG PRODUCTS LIST

B - 61

APPENDIX B

PRODUCT NAME SORTED BY APPLICANT


** H **

* HOSPIRA INC LIDOCAINE HYDROCHLORIDE, LIDOCAINE HYDROCHLORIDE LIPOSYN II 10%, SAFFLOWER OIL LIPOSYN II 20%, SAFFLOWER OIL LIPOSYN III 10%, SOYBEAN OIL LIPOSYN III 20%, SOYBEAN OIL LIPOSYN III 30%, SOYBEAN OIL LORAZEPAM, LORAZEPAM
LTA II KIT, LIDOCAINE HYDROCHLORIDE
M.V.I. ADULT (PHARMACY BULK PACKAGE), ASCORBIC ACID M.V.I. ADULT, ASCORBIC ACID M.V.I. PEDIATRIC, ASCORBIC ACID M.V.I.-12 (WITHOUT VITAMIN K), ASCORBIC ACID MAGNESIUM SULFATE IN DEXTROSE 5% IN PLASTIC CONTAINER, MAGNESIUM SULFATE MAGNESIUM SULFATE IN PLASTIC CONTAINER, MAGNESIUM SULFATE MAGNESIUM SULFATE, MAGNESIUM SULFATE MANGANESE CHLORIDE IN PLASTIC CONTAINER, MANGANESE CHLORIDE MANNITOL 10% IN PLASTIC CONTAINER, MANNITOL MANNITOL 15% IN PLASTIC CONTAINER, MANNITOL MANNITOL 20% IN PLASTIC CONTAINER, MANNITOL MANNITOL 25%, MANNITOL MANNITOL 5% IN PLASTIC CONTAINER, MANNITOL MARCAINE HYDROCHLORIDE PRESERVATIVE FREE, BUPIVACAINE HYDROCHLORIDE MARCAINE HYDROCHLORIDE W/ EPINEPHRINE PRESERVATIVE FREE, BUPIVACAINE HYDROCHLORIDE MARCAINE HYDROCHLORIDE W/ EPINEPHRINE, BUPIVACAINE HYDROCHLORIDE MARCAINE HYDROCHLORIDE, BUPIVACAINE HYDROCHLORIDE MARCAINE, BUPIVACAINE HYDROCHLORIDE MEPERIDINE HYDROCHLORIDE PRESERVATIVE FREE, MEPERIDINE HYDROCHLORIDE METHOTREXATE SODIUM PRESERVATIVE FREE, METHOTREXATE SODIUM METHOTREXATE SODIUM, METHOTREXATE SODIUM METOCLOPRAMIDE HYDROCHLORIDE, METOCLOPRAMIDE HYDROCHLORIDE METOPROLOL TARTRATE, METOPROLOL TARTRATE METRONIDAZOLE IN PLASTIC CONTAINER, METRONIDAZOLE MIDAZOLAM HYDROCHLORIDE PRESERVATIVE FREE, MIDAZOLAM HYDROCHLORIDE MIDAZOLAM HYDROCHLORIDE, MIDAZOLAM HYDROCHLORIDE MILRINONE LACTATE IN DEXTROSE 5% IN PLASTIC CONTAINER, MILRINONE LACTATE MILRINONE LACTATE, MILRINONE LACTATE MITOXANTRONE HYDROCHLORIDE, MITOXANTRONE HYDROCHLORIDE MORPHINE SULFATE, MORPHINE SULFATE NALBUPHINE HYDROCHLORIDE, NALBUPHINE HYDROCHLORIDE NALOXONE HYDROCHLORIDE, NALOXONE HYDROCHLORIDE NITROGLYCERIN IN DEXTROSE 5%, NITROGLYCERIN NITROGLYCERIN, NITROGLYCERIN NITROPRESS, SODIUM NITROPRUSSIDE NORMOSOL-M AND DEXTROSE 5% IN PLASTIC CONTAINER, DEXTROSE NORMOSOL-R AND DEXTROSE 5% IN PLASTIC CONTAINER, DEXTROSE NORMOSOL-R IN PLASTIC CONTAINER, MAGNESIUM CHLORIDE NOVAMINE 11.4%, AMINO ACIDS NOVAMINE 15%, AMINO ACIDS ONDANSETRON HYDROCHLORIDE AND DEXTROSE IN PLASTIC CONTAINER, ONDANSETRON HYDROCHLORIDE ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE, ONDANSETRON HYDROCHLORIDE ONDANSETRON HYDROCHLORIDE, ONDANSETRON HYDROCHLORIDE PACLITAXEL, PACLITAXEL PAMIDRONATE DISODIUM, PAMIDRONATE DISODIUM PANCURONIUM BROMIDE, PANCURONIUM BROMIDE PEDIATRIC LTA KIT, LIDOCAINE HYDROCHLORIDE PHENYTOIN SODIUM, PHENYTOIN SODIUM PHYSIOSOL IN PLASTIC CONTAINER, MAGNESIUM CHLORIDE PHYSIOSOL PH 7.4 IN PLASTIC CONTAINER, MAGNESIUM CHLORIDE PLEGISOL IN PLASTIC CONTAINER, CALCIUM CHLORIDE POTASSIUM ACETATE IN PLASTIC CONTAINER, POTASSIUM ACETATE POTASSIUM CHLORIDE 0.149% IN SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER, POTASSIUM CHLORIDE POTASSIUM CHLORIDE 10MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.225% IN PLASTIC CONTAINER, DEXTROSE

SEPTEMBER 2010 - APPROVED DRUG PRODUCTS LIST

B - 62

APPENDIX B

PRODUCT NAME SORTED BY APPLICANT


** H **

* HOSPIRA INC POTASSIUM CHLORIDE 10MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.3% IN PLASTIC CONTAINER, DEXTROSE POTASSIUM CHLORIDE 10MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER,
DEXTROSE
POTASSIUM CHLORIDE 10MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER,
DEXTROSE
POTASSIUM CHLORIDE 10MEQ IN PLASTIC CONTAINER, POTASSIUM CHLORIDE
POTASSIUM CHLORIDE 15MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.225% IN PLASTIC CONTAINER,
DEXTROSE
POTASSIUM CHLORIDE 15MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.3% IN PLASTIC CONTAINER,
DEXTROSE
POTASSIUM CHLORIDE 15MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER,
DEXTROSE
POTASSIUM CHLORIDE 15MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER,
DEXTROSE
POTASSIUM CHLORIDE 20MEQ IN DEXTROSE 5% AND LACTATED RINGER'S IN PLASTIC CONTAINER,
CALCIUM CHLORIDE
POTASSIUM CHLORIDE 20MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.225% IN PLASTIC CONTAINER,
DEXTROSE
POTASSIUM CHLORIDE 20MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.3% IN PLASTIC CONTAINER,
DEXTROSE
POTASSIUM CHLORIDE 20MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER,
DEXTROSE
POTASSIUM CHLORIDE 20MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER,
DEXTROSE
POTASSIUM CHLORIDE 20MEQ IN DEXTROSE 5% IN PLASTIC CONTAINER, DEXTROSE
POTASSIUM CHLORIDE 20MEQ IN DEXTROSE 5% IN SODIUM CHLORIDE 0.3% IN PLASTIC CONTAINER,
DEXTROSE
POTASSIUM CHLORIDE 20MEQ IN PLASTIC CONTAINER, POTASSIUM CHLORIDE
POTASSIUM CHLORIDE 20MEQ IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, POTASSIUM CHLORIDE
POTASSIUM CHLORIDE 30MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.225% IN PLASTIC CONTAINER,
DEXTROSE
POTASSIUM CHLORIDE 30MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.3% IN PLASTIC CONTAINER,
DEXTROSE
POTASSIUM CHLORIDE 30MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER,
DEXTROSE
POTASSIUM CHLORIDE 30MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER,
DEXTROSE
POTASSIUM CHLORIDE 30MEQ IN DEXTROSE 5% IN PLASTIC CONTAINER, DEXTROSE
POTASSIUM CHLORIDE 30MEQ IN PLASTIC CONTAINER, POTASSIUM CHLORIDE
POTASSIUM CHLORIDE 40MEQ IN DEXTROSE 5% AND LACTATED RINGER'S IN PLASTIC CONTAINER,
CALCIUM CHLORIDE
POTASSIUM CHLORIDE 40MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.225% IN PLASTIC CONTAINER,
DEXTROSE
POTASSIUM CHLORIDE 40MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.3% IN PLASTIC CONTAINER,
DEXTROSE
POTASSIUM CHLORIDE 40MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER,
DEXTROSE
POTASSIUM CHLORIDE 40MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER,
DEXTROSE
POTASSIUM CHLORIDE 40MEQ IN DEXTROSE 5% IN PLASTIC CONTAINER, DEXTROSE
POTASSIUM CHLORIDE 40MEQ IN PLASTIC CONTAINER, POTASSIUM CHLORIDE
POTASSIUM CHLORIDE 40MEQ IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, POTASSIUM CHLORIDE
POTASSIUM CHLORIDE 5MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.225% IN PLASTIC CONTAINER,
DEXTROSE
POTASSIUM CHLORIDE 5MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.3% IN PLASTIC CONTAINER,
DEXTROSE
POTASSIUM CHLORIDE 5MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER,
DEXTROSE
POTASSIUM CHLORIDE 5MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, DEXTROSE POTASSIUM CHLORIDE, POTASSIUM CHLORIDE PRECEDEX, DEXMEDETOMIDINE HYDROCHLORIDE PROCAINAMIDE HYDROCHLORIDE, PROCAINAMIDE HYDROCHLORIDE PROMETHAZINE HYDROCHLORIDE, PROMETHAZINE HYDROCHLORIDE PROPOFOL, PROPOFOL QUELICIN PRESERVATIVE FREE, SUCCINYLCHOLINE CHLORIDE QUELICIN, SUCCINYLCHOLINE CHLORIDE

SEPTEMBER 2010 - APPROVED DRUG PRODUCTS LIST

B - 63

APPENDIX B

PRODUCT NAME SORTED BY APPLICANT


** H **

* HOSPIRA INC RINGER'S IN PLASTIC CONTAINER, CALCIUM CHLORIDE ROCURONIUM BROMIDE, ROCURONIUM BROMIDE SODIUM ACETATE IN PLASTIC CONTAINER, SODIUM ACETATE ANHYDROUS SODIUM BICARBONATE, SODIUM BICARBONATE SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER, SODIUM CHLORIDE SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, SODIUM CHLORIDE SODIUM CHLORIDE IN PLASTIC CONTAINER, SODIUM CHLORIDE SODIUM LACTATE IN PLASTIC CONTAINER, SODIUM LACTATE SODIUM PHOSPHATES IN PLASTIC CONTAINER, SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE SORBITOL-MANNITOL IN PLASTIC CONTAINER, MANNITOL STERILE WATER FOR INJECTION IN PLASTIC CONTAINER, STERILE WATER FOR INJECTION STERILE WATER IN PLASTIC CONTAINER, STERILE WATER FOR IRRIGATION SUFENTANIL CITRATE, SUFENTANIL CITRATE TALWIN, PENTAZOCINE LACTATE TAZICEF, CEFTAZIDIME THAM, TROMETHAMINE THEOPHYLLINE IN DEXTROSE 5% IN PLASTIC CONTAINER, THEOPHYLLINE THIAMINE HYDROCHLORIDE, THIAMINE HYDROCHLORIDE TOBRAMYCIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, TOBRAMYCIN SULFATE TOBRAMYCIN SULFATE, TOBRAMYCIN SULFATE TPN ELECTROLYTES IN PLASTIC CONTAINER, CALCIUM CHLORIDE TRIMETHOBENZAMIDE HYDROCHLORIDE, TRIMETHOBENZAMIDE HYDROCHLORIDE VANCOMYCIN HYDROCHLORIDE, VANCOMYCIN HYDROCHLORIDE VECURONIUM BROMIDE, VECURONIUM BROMIDE VERAPAMIL HYDROCHLORIDE, VERAPAMIL HYDROCHLORIDE VINCRISTINE SULFATE PFS, VINCRISTINE SULFATE VINORELBINE TARTRATE, VINORELBINE TARTRATE VITAMIN K1, PHYTONADIONE
ZINC CHLORIDE IN PLASTIC CONTAINER, ZINC CHLORIDE
HOSPIRA INC * HOSPIRA INC HEPARIN SODIUM, HEPARIN SODIUM HYDROMORPHONE HYDROCHLORIDE, HYDROMORPHONE HYDROCHLORIDE MEPIVACAINE HYDROCHLORIDE, MEPIVACAINE HYDROCHLORIDE NIPENT, PENTOSTATIN OXALIPLATIN, OXALIPLATIN
VANCOMYCIN HYDROCHLORIDE, VANCOMYCIN HYDROCHLORIDE
HOSPIRA WORLDWIDE * HOSPIRA WORLDWIDE PTY OXALIPLATIN, OXALIPLATIN HUAHAI US INC * HUAHAI US INC BENAZEPRIL HYDROCHLORIDE, ROPINIROLE HYDROCHLORIDE,

BENAZEPRIL HYDROCHLORIDE
ROPINIROLE HYDROCHLORIDE

IBI * ISTITUTO BIOCHIMICO ITALIANO SPA AMPICILLIN SODIUM, AMPICILLIN SODIUM IMPAX LABS * IMPAX LABORATORIES INC ACARBOSE, ACARBOSE ALPRAZOLAM, ALPRAZOLAM ANAGRELIDE HYDROCHLORIDE, ANAGRELIDE HYDROCHLORIDE BACLOFEN, BACLOFEN BENZPHETAMINE HYDROCHLORIDE, BENZPHETAMINE HYDROCHLORIDE BETHANECHOL CHLORIDE, BETHANECHOL CHLORIDE BUPROPION HYDROCHLORIDE, BUPROPION HYDROCHLORIDE CARBIDOPA AND LEVODOPA, CARBIDOPA CHLOROQUINE PHOSPHATE, CHLOROQUINE PHOSPHATE CLONIDINE HYDROCHLORIDE, CLONIDINE HYDROCHLORIDE COLESTIPOL HYDROCHLORIDE, COLESTIPOL HYDROCHLORIDE DANTROLENE SODIUM, DANTROLENE SODIUM
DEMECLOCYCLINE HYDROCHLORIDE, DEMECLOCYCLINE HYDROCHLORIDE

SEPTEMBER 2010 - APPROVED DRUG PRODUCTS LIST

B - 64

APPENDIX B

PRODUCT NAME SORTED BY APPLICANT


** I **

* IMPAX LABORATORIES INC DIGOXIN, DIGOXIN DIPYRIDAMOLE, DIPYRIDAMOLE DIVALPROEX SODIUM, DIVALPROEX SODIUM FENOFIBRATE (MICRONIZED), FENOFIBRATE FENOFIBRATE, FENOFIBRATE FLUDROCORTISONE ACETATE, FLUDROCORTISONE ACETATE GALANTAMINE HYDROBROMIDE, GALANTAMINE HYDROBROMIDE LORATADINE AND PSEUDOEPHEDRINE SULFATE, LORATADINE (OTC) LORATADINE, LORATADINE (OTC) METFORMIN HYDROCHLORIDE, METFORMIN HYDROCHLORIDE METHYLTESTOSTERONE, METHYLTESTOSTERONE MINOCYCLINE HYDROCHLORIDE, MINOCYCLINE HYDROCHLORIDE NADOLOL AND BENDROFLUMETHIAZIDE, BENDROFLUMETHIAZIDE OMEPRAZOLE, OMEPRAZOLE PENTOXIFYLLINE, PENTOXIFYLLINE PILOCARPINE HYDROCHLORIDE, PILOCARPINE HYDROCHLORIDE PRIMIDONE, PRIMIDONE PROMETHAZINE HYDROCHLORIDE, PROMETHAZINE HYDROCHLORIDE PYRIDOSTIGMINE BROMIDE, PYRIDOSTIGMINE BROMIDE RILUZOLE, RILUZOLE RIMANTADINE HYDROCHLORIDE, RIMANTADINE HYDROCHLORIDE TAMSULOSIN HYDROCHLORIDE, TAMSULOSIN HYDROCHLORIDE TERBUTALINE SULFATE, TERBUTALINE SULFATE
TETRACYCLINE HYDROCHLORIDE, TETRACYCLINE HYDROCHLORIDE
IMPAX LABS INC * IMPAX LABORATORIES INC CABERGOLINE, CABERGOLINE
MINOCYCLINE HYDROCHLORIDE,

MINOCYCLINE HYDROCHLORIDE

IMPAX PHARMS * IMPAX PHARMACEUTICALS FLAVOXATE HYDROCHLORIDE, FLAVOXATE HYDROCHLORIDE GEMFIBROZIL, GEMFIBROZIL MIDODRINE HYDROCHLORIDE, MIDODRINE HYDROCHLORIDE ORPHENADRINE CITRATE, ORPHENADRINE CITRATE OXYBUTYNIN CHLORIDE, OXYBUTYNIN CHLORIDE
SOTALOL HYDROCHLORIDE, SOTALOL HYDROCHLORIDE
INALCO * INALCO SPA LACTULOSE,

LACTULOSE

INDICUS PHARMA * INDICUS PHARMA LLC METFORMIN HYDROCHLORIDE, INO * INO THERAPEUTICS INC INOMAX, NITRIC OXIDE

METFORMIN HYDROCHLORIDE

INSIGHT PHARMS * INSIGHT PHARMACEUTICALS CORP NIX, PERMETHRIN (OTC) INSPIRE * INSPIRE PHARMACEUTICALS INC AZASITE, AZITHROMYCIN INST BIOCHEM * INSTITUT BIOCHEMIQUE SA FLECTOR, DICLOFENAC EPOLAMINE INST BIOCHIMIQUE * INSTITUTE BIOCHIMIQUE SA (IBSA) TIROSINT, LEVOTHYROXINE SODIUM INSTITUTO BIOCHEMICO * INSTITUTO BIOCHEMICO ITALIANO SPA AMPICILLIN SODIUM, AMPICILLIN SODIUM

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APPENDIX B

PRODUCT NAME SORTED BY APPLICANT


** I **

INSTITUTO BIOCHIMICO * INSTITUTO BIOCHIMICO ITALIANO SPA AMPICILLIN AND SULBACTAM, AMPICILLIN SODIUM INTENDIS * INTENDIS INC DESONATE, DESONIDE
FINACEA, AZELAIC ACID
INTERGEL PHARM * INTERGEL PHARMACEUTICAL INC NIFEDIPINE, NIFEDIPINE INTL MEDICATED * INTERNATIONAL MEDICATED SYSTEMS LTD BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREE, BUPIVACAINE HYDROCHLORIDE MIDAZOLAM HYDROCHLORIDE, MIDAZOLAM HYDROCHLORIDE
MILRINONE LACTATE, MILRINONE LACTATE
INTL MEDICATION * INTERNATIONAL MEDICATION SYSTEM AMINOPHYLLINE, AMINOPHYLLINE DIPHENHYDRAMINE HYDROCHLORIDE PRESERVATIVE FREE, DIPHENHYDRAMINE HYDROCHLORIDE FUROSEMIDE, FUROSEMIDE ISOPROTERENOL HYDROCHLORIDE, ISOPROTERENOL HYDROCHLORIDE LARYNG-O-JET KIT, LIDOCAINE HYDROCHLORIDE LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE, LIDOCAINE HYDROCHLORIDE LIDOCAINE HYDROCHLORIDE, LIDOCAINE HYDROCHLORIDE MANNITOL 25%, MANNITOL MEPERIDINE HYDROCHLORIDE PRESERVATIVE FREE, MEPERIDINE HYDROCHLORIDE NALOXONE HYDROCHLORIDE, NALOXONE HYDROCHLORIDE PHYTONADIONE, PHYTONADIONE POTASSIUM CHLORIDE, POTASSIUM CHLORIDE PROCAINAMIDE HYDROCHLORIDE, PROCAINAMIDE HYDROCHLORIDE
VERAPAMIL HYDROCHLORIDE, VERAPAMIL HYDROCHLORIDE
* INTERNATIONAL MEDICATION SYSTEMS LTD DILTIAZEM HYDROCHLORIDE, DILTIAZEM HYDROCHLORIDE
MIDAZOLAM HYDROCHLORIDE, MIDAZOLAM HYDROCHLORIDE
INTL MEDICATION SYS * INTERNATIONAL MEDICATION SYSTEMS LTD LORAZEPAM, LORAZEPAM INVAGEN PHARMS * INVAGEN PHARMACEUTICALS INC AMLODIPINE BESYLATE, AMLODIPINE BESYLATE BENZTROPINE MESYLATE, BENZTROPINE MESYLATE CARBINOXAMINE MALEATE, CARBINOXAMINE MALEATE CITALOPRAM HYDROBROMIDE, CITALOPRAM HYDROBROMIDE FOLIC ACID, FOLIC ACID FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE, FOSINOPRIL SODIUM FOSINOPRIL SODIUM, FOSINOPRIL SODIUM GABAPENTIN, GABAPENTIN GEMFIBROZIL, GEMFIBROZIL GLIMEPIRIDE, GLIMEPIRIDE HYDRALAZINE HYDROCHLORIDE, HYDRALAZINE HYDROCHLORIDE HYDROXYZINE HYDROCHLORIDE, HYDROXYZINE HYDROCHLORIDE LEVETIRACETAM, LEVETIRACETAM MEPROBAMATE, MEPROBAMATE NABUMETONE, NABUMETONE QUINAPRIL HYDROCHLORIDE, QUINAPRIL HYDROCHLORIDE RAMIPRIL, RAMIPRIL SERTRALINE HYDROCHLORIDE, SERTRALINE HYDROCHLORIDE TERBINAFINE HYDROCHLORIDE, TERBINAFINE HYDROCHLORIDE TOPIRAMATE, TOPIRAMATE TRANDOLAPRIL, TRANDOLAPRIL ZOLPIDEM TARTRATE, ZOLPIDEM TARTRATE
ZONISAMIDE, ZONISAMIDE

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APPENDIX B

PRODUCT NAME SORTED BY APPLICANT


** I **

INWOOD LABS * INWOOD LABORATORIES INC SUB FOREST LABORATORIES INC CARBAMAZEPINE, CARBAMAZEPINE
THEOPHYLLINE, THEOPHYLLINE
IPCA LABS LTD * IPCA LABORATORIES LTD ATENOLOL, ATENOLOL FUROSEMIDE, FUROSEMIDE HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE HYDROXYCHLOROQUINE SULFATE, HYDROXYCHLOROQUINE SULFATE METOCLOPRAMIDE HYDROCHLORIDE, METOCLOPRAMIDE HYDROCHLORIDE METOPROLOL TARTRATE, METOPROLOL TARTRATE
PROPRANOLOL HYDROCHLORIDE, PROPRANOLOL HYDROCHLORIDE
IPR * IPR PHARMACEUTICALS INC ATENOLOL AND CHLORTHALIDONE, ATENOLOL ATENOLOL, ATENOLOL CRESTOR, ROSUVASTATIN CALCIUM
ZOMIG, ZOLMITRIPTAN
IPSEN LTD * IPSEN LTD APOKYN,

APOMORPHINE HYDROCHLORIDE

IROKO PHARMS * IROKO PHARMACEUTICALS LLC INDOCIN, INDOMETHACIN ISO TEX * ISO TEX DIAGNOSTICS INC JEANATOPE, ALBUMIN IODINATED I-125 SERUM
MEGATOPE, ALBUMIN IODINATED I-131 SERUM
ISTA PHARMS * ISTA PHARMACEUTICALS BEPREVE, BEPOTASTINE BESILATE ISTALOL, TIMOLOL MALEATE VITRASE, HYALURONIDASE
XIBROM, BROMFENAC SODIUM
ISTITUTO BIOCHIMICO * ISTITUTO BIOCHIMICO ITALIANO GIOVANNI LORENZINI PIPERACILLIN, PIPERACILLIN SODIUM IVAX PHARMS * IVAX PHARMACEUTICALS INC PERINDOPRIL ERBUMINE, PERINDOPRIL ERBUMINE IVAX SUB TEVA PHARMS * IVAX PHARMACEUTICALS INC SUB TEVA PHARMACEUTICALS USA ACYCLOVIR, ACYCLOVIR ANAGRELIDE HYDROCHLORIDE, ANAGRELIDE HYDROCHLORIDE BACLOFEN, BACLOFEN BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE, BENAZEPRIL HYDROCHLORIDE BENAZEPRIL HYDROCHLORIDE, BENAZEPRIL HYDROCHLORIDE BUMETANIDE, BUMETANIDE BUSPIRONE HYDROCHLORIDE, BUSPIRONE HYDROCHLORIDE CABERGOLINE, CABERGOLINE CAPTOPRIL AND HYDROCHLOROTHIAZIDE, CAPTOPRIL CEFADROXIL, CEFADROXIL/CEFADROXIL HEMIHYDRATE CEPHALEXIN, CEPHALEXIN CETIRIZINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE, CETIRIZINE HYDROCHLORIDE (OTC) CILOSTAZOL, CILOSTAZOL
CIMETIDINE, CIMETIDINE
CIMETIDINE, CIMETIDINE (OTC)
CIPROFLOXACIN HYDROCHLORIDE, CIPROFLOXACIN HYDROCHLORIDE
CITALOPRAM HYDROBROMIDE, CITALOPRAM HYDROBROMIDE

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APPENDIX B

PRODUCT NAME SORTED BY APPLICANT


** I **

* IVAX PHARMACEUTICALS INC SUB TEVA PHARMACEUTICALS USA CLARITHROMYCIN, CLARITHROMYCIN CLOZAPINE, CLOZAPINE CYCLOSPORINE, CYCLOSPORINE CYPROHEPTADINE HYDROCHLORIDE, CYPROHEPTADINE HYDROCHLORIDE DIAZEPAM, DIAZEPAM DOXAZOSIN MESYLATE, DOXAZOSIN MESYLATE DOXYCYCLINE HYCLATE, DOXYCYCLINE HYCLATE DOXYCYCLINE, DOXYCYCLINE FAMOTIDINE, FAMOTIDINE FAMOTIDINE, FAMOTIDINE (OTC) FENOPROFEN CALCIUM, FENOPROFEN CALCIUM FLUCONAZOLE, FLUCONAZOLE FLUOXETINE HYDROCHLORIDE, FLUOXETINE HYDROCHLORIDE FLUTAMIDE, FLUTAMIDE FUROSEMIDE, FUROSEMIDE GABAPENTIN, GABAPENTIN GLIPIZIDE, GLIPIZIDE GLYBURIDE AND METFORMIN HYDROCHLORIDE, GLYBURIDE GRISEOFULVIN, GRISEOFULVIN, MICROCRYSTALLINE GUANABENZ ACETATE, GUANABENZ ACETATE HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE HYDROXYZINE PAMOATE, HYDROXYZINE PAMOATE INDAPAMIDE, INDAPAMIDE INDOMETHACIN, INDOMETHACIN LABETALOL HYDROCHLORIDE, LABETALOL HYDROCHLORIDE LISINOPRIL AND HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE LISINOPRIL, LISINOPRIL LORAZEPAM, LORAZEPAM METFORMIN HYDROCHLORIDE, METFORMIN HYDROCHLORIDE METHOCARBAMOL AND ASPIRIN, ASPIRIN METHYLDOPA, METHYLDOPA METRONIDAZOLE, METRONIDAZOLE MISOPROSTOL, MISOPROSTOL NADOLOL, NADOLOL NEFAZODONE HYDROCHLORIDE, NEFAZODONE HYDROCHLORIDE NICOTINE POLACRILEX, NICOTINE POLACRILEX (OTC) NITROFURANTOIN, NITROFURANTOIN, MACROCRYSTALLINE OXAPROZIN, OXAPROZIN OXAZEPAM, OXAZEPAM PRAZOSIN HYDROCHLORIDE, PRAZOSIN HYDROCHLORIDE PREDNISOLONE, PREDNISOLONE PROBENECID AND COLCHICINE, COLCHICINE PROBENECID, PROBENECID RANITIDINE HYDROCHLORIDE, RANITIDINE HYDROCHLORIDE RANITIDINE HYDROCHLORIDE, RANITIDINE HYDROCHLORIDE (OTC) SERTRALINE HYDROCHLORIDE, SERTRALINE HYDROCHLORIDE SIMVASTATIN, SIMVASTATIN SULFISOXAZOLE, SULFISOXAZOLE TERAZOSIN HYDROCHLORIDE, TERAZOSIN HYDROCHLORIDE TETRACYCLINE HYDROCHLORIDE, TETRACYCLINE HYDROCHLORIDE TOLMETIN SODIUM, TOLMETIN SODIUM TRIAMTERENE AND HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE
VERAPAMIL HYDROCHLORIDE, VERAPAMIL HYDROCHLORIDE
JACOBUS * JACOBUS PHARMACEUTICAL CO DAPSONE, DAPSONE
PASER, AMINOSALICYLIC ACID
JAZZ * JAZZ PHARMACEUTICALS LUVOX CR, FLUVOXAMINE MALEATE LUVOX, FLUVOXAMINE MALEATE
XYREM, SODIUM OXYBATE

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APPENDIX B

PRODUCT NAME SORTED BY APPLICANT


** J **

JHP PHARMS * JHP PHARMACEUTICALS LLC BREVITAL SODIUM, METHOHEXITAL SODIUM COLY-MYCIN M, COLISTIMETHATE SODIUM COLY-MYCIN S, COLISTIN SULFATE DANTRIUM, DANTROLENE SODIUM DELESTROGEN, ESTRADIOL VALERATE KETALAR, KETAMINE HYDROCHLORIDE PITOCIN, OXYTOCIN SUMATRIPTAN SUCCINATE, SUMATRIPTAN SUCCINATE TIGAN, TRIMETHOBENZAMIDE HYDROCHLORIDE
TRIOSTAT, LIOTHYRONINE SODIUM
JOHN O BUTLER CO * JOHN O BUTLER CO CHLORHEXIDINE GLUCONATE,

CHLORHEXIDINE GLUCONATE

JOHNSON AND JOHNSON * JOHNSON AND JOHNSON CONSUMER COMPANIES INC RETIN-A, TRETINOIN * JOHNSON AND JOHNSON GROUP CONSUMER COMPANIES MEN'S ROGAINE, MINOXIDIL (OTC) ROGAINE (FOR MEN), MINOXIDIL (OTC) ROGAINE (FOR WOMEN), MINOXIDIL (OTC) ROGAINE EXTRA STRENGTH (FOR MEN), MINOXIDIL (OTC) VISINE L.R., OXYMETAZOLINE HYDROCHLORIDE (OTC)
VISINE-A, NAPHAZOLINE HYDROCHLORIDE (OTC)
* JOHNSON AND JOHNSON HEALTHCARE PRODUCTS MONISTAT 1 COMBINATION PACK, MICONAZOLE NITRATE (OTC) MONISTAT 3 COMBINATION PACK (PREFILLED), MICONAZOLE NITRATE (OTC) MONISTAT 3 COMBINATION PACK, MICONAZOLE NITRATE (OTC) MONISTAT 3, MICONAZOLE NITRATE (OTC) MONISTAT 7 COMBINATION PACK, MICONAZOLE NITRATE (OTC) MONISTAT 7, MICONAZOLE NITRATE (OTC)
MONISTAT-3 COMBINATION PACK, MICONAZOLE NITRATE (OTC)
* JOHNSON AND JOHNSON PHARMACEUTICAL RESEARCH AND DEVELOPMENT LLC INVEGA SUSTENNA, PALIPERIDONE PALMITATE KALI LABS * KALI LABORATORIES INC ALPRAZOLAM, ALPRAZOLAM CAPTOPRIL, CAPTOPRIL CLONAZEPAM, CLONAZEPAM GLIPIZIDE, GLIPIZIDE GLYCOPYRROLATE, GLYCOPYRROLATE METRONIDAZOLE, METRONIDAZOLE ONDANSETRON, ONDANSETRON OXANDROLONE, OXANDROLONE TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN, ACETAMINOPHEN TRANYLCYPROMINE SULFATE, TRANYLCYPROMINE SULFATE
VERAPAMIL HYDROCHLORIDE, VERAPAMIL HYDROCHLORIDE
* KALI LABS ONDANSETRON HYDROCHLORIDE, ONDANSETRON HYDROCHLORIDE KENDALL LP * KENDALL CO LP THERMAZENE,

SILVER SULFADIAZINE

KEY PHARMS * KEY PHARMACEUTICALS INC SUB SCHERING PLOUGH CORP NITRO-DUR, NITROGLYCERIN KIEL * KIEL LABORATORIES INC ORPHENADRINE CITRATE, KING PHARMS * KING PHARMACEUTICALS INC ALTACE, RAMIPRIL

ORPHENADRINE CITRATE

SEPTEMBER 2010 - APPROVED DRUG PRODUCTS LIST

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APPENDIX B

PRODUCT NAME SORTED BY APPLICANT


** K **

* KING PHARMACEUTICALS INC AVINZA, MORPHINE SULFATE BICILLIN C-R 900/300, PENICILLIN G BENZATHINE BICILLIN C-R, PENICILLIN G BENZATHINE BICILLIN L-A, PENICILLIN G BENZATHINE CORGARD, NADOLOL CORZIDE, BENDROFLUMETHIAZIDE CYTOMEL, LIOTHYRONINE SODIUM INTAL, CROMOLYN SODIUM LEVOXYL, LEVOTHYROXINE SODIUM PENICILLIN G PROCAINE, PENICILLIN G PROCAINE SILVADENE, SILVER SULFADIAZINE SKELAXIN, METAXALONE SYNERCID, DALFOPRISTIN
TIGAN, TRIMETHOBENZAMIDE HYDROCHLORIDE
* KING PHARMACEUTICALS RESEARCH AND DEVELOPMENT INC SUB KING PHARMACEUTICALS INC SONATA, ZALEPLON TAPAZOLE, METHIMAZOLE
TUSSIGON, HOMATROPINE METHYLBROMIDE
KOWA * KOWA RESEARCH INSTITUTE INC LIVALO, PITAVASTATIN CALCIUM KREMERS URBAN * KREMERS URBAN CO ISOSORBIDE MONONITRATE, ISOSORBIDE MONONITRATE
NITROGLYCERIN, NITROGLYCERIN
KREMERS URBAN DEV * KREMERS URBAN DEVELOPMENT CO GLYCOLAX, POLYETHYLENE GLYCOL 3350 OMEPRAZOLE, OMEPRAZOLE
KRKA DD NOVO MESTO * KRKA DD NOVO MESTO ENALAPRIL MALEATE,

(OTC)

ENALAPRIL MALEATE

KUDCO IRELAND * KUDCO IRELAND LTD BICALUTAMIDE, BICALUTAMIDE KV PHARM * KV PHARMACEUTICAL CO BENZONATATE, BENZONATATE BUSPIRONE HYDROCHLORIDE, BUSPIRONE HYDROCHLORIDE CLINDESSE, CLINDAMYCIN PHOSPHATE DEXTROAMPHETAMINE SULFATE, DEXTROAMPHETAMINE SULFATE DILTIAZEM HYDROCHLORIDE, DILTIAZEM HYDROCHLORIDE DISOPYRAMIDE PHOSPHATE, DISOPYRAMIDE PHOSPHATE DOXAZOSIN MESYLATE, DOXAZOSIN MESYLATE EVAMIST, ESTRADIOL FLUTICASONE PROPIONATE, FLUTICASONE PROPIONATE GYNAZOLE-1, BUTOCONAZOLE NITRATE HYDROCODONE BITARTRATE AND ACETAMINOPHEN, ACETAMINOPHEN HYDROMORPHONE HYDROCHLORIDE, HYDROMORPHONE HYDROCHLORIDE ISOSORBIDE MONONITRATE, ISOSORBIDE MONONITRATE METOPROLOL SUCCINATE, METOPROLOL SUCCINATE MORPHINE SULFATE, MORPHINE SULFATE NYSTATIN, NYSTATIN ONDANSETRON, ONDANSETRON OXYCODONE HYDROCHLORIDE, OXYCODONE HYDROCHLORIDE POTASSIUM CHLORIDE, POTASSIUM CHLORIDE PREDNISOLONE SODIUM PHOSPHATE, PREDNISOLONE SODIUM PHOSPHATE PREDNISOLONE, PREDNISOLONE
PROPAFENONE HYDROCHLORIDE, PROPAFENONE HYDROCHLORIDE

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APPENDIX B

PRODUCT NAME SORTED BY APPLICANT


** K **

KVK TECH * KVK TECH INC BETAXOLOL HYDROCHLORIDE, BETAXOLOL HYDROCHLORIDE HYDROXYZINE HYDROCHLORIDE, HYDROXYZINE HYDROCHLORIDE KALEXATE, SODIUM POLYSTYRENE SULFONATE PHENTERMINE HYDROCHLORIDE, PHENTERMINE HYDROCHLORIDE
PROMETHAZINE HYDROCHLORIDE, PROMETHAZINE HYDROCHLORIDE
LABOPHARM * LABOPHARM INC OLEPTRO, TRAZODONE HYDROCHLORIDE LANDELA PHARM * LANDELA PHARMACEUTICAL ALBUTEROL SULFATE, ALBUTEROL SULFATE FLUOXETINE HYDROCHLORIDE, FLUOXETINE HYDROCHLORIDE
IPRATROPIUM BROMIDE, IPRATROPIUM BROMIDE
LANNETT * LANNETT CO INC ACETAZOLAMIDE, ACETAZOLAMIDE DICYCLOMINE HYDROCHLORIDE, DICYCLOMINE HYDROCHLORIDE DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE, ATROPINE SULFATE LANORINAL, ASPIRIN METHOCARBAMOL, METHOCARBAMOL PHENTERMINE HYDROCHLORIDE, PHENTERMINE HYDROCHLORIDE PRIMIDONE, PRIMIDONE PROBALAN, PROBENECID
SERPALAN, RESERPINE
* LANNETT HOLDINGS INC BACLOFEN, BACLOFEN BENZTROPINE MESYLATE, BENZTROPINE MESYLATE BETHANECHOL CHLORIDE, BETHANECHOL CHLORIDE CLINDAMYCIN HYDROCHLORIDE, CLINDAMYCIN HYDROCHLORIDE DANAZOL, DANAZOL DIPYRIDAMOLE, DIPYRIDAMOLE DOXYCYCLINE HYCLATE, DOXYCYCLINE HYCLATE DOXYCYCLINE, DOXYCYCLINE FLUOXETINE HYDROCHLORIDE, FLUOXETINE HYDROCHLORIDE FLUPHENAZINE HYDROCHLORIDE, FLUPHENAZINE HYDROCHLORIDE HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE HYDROMORPHONE HYDROCHLORIDE, HYDROMORPHONE HYDROCHLORIDE ONDANSETRON HYDROCHLORIDE, ONDANSETRON HYDROCHLORIDE PILOCARPINE HYDROCHLORIDE, PILOCARPINE HYDROCHLORIDE RIFAMPIN, RIFAMPIN TERBUTALINE SULFATE, TERBUTALINE SULFATE
URSODIOL, URSODIOL
LANTHEUS MEDCL * LANTHEUS MEDICAL IMAGING INC ABLAVAR, GADOFOSVESET TRISODIUM CARDIOLITE, TECHNETIUM TC-99M SESTAMIBI KIT DEFINITY, PERFLUTREN GALLIUM CITRATE GA 67, GALLIUM CITRATE GA-67 NEUROLITE, TECHNETIUM TC-99M BICISATE KIT TECHNELITE, TECHNETIUM TC-99M SODIUM PERTECHNETATE GENERATOR THALLOUS CHLORIDE TL 201, THALLOUS CHLORIDE TL-201
XENON XE 133, XENON XE-133
LAVIPHARM LABS * LAVIPHARM LABORATORIES INC FENTANYL-100, FENTANYL FENTANYL-25, FENTANYL FENTANYL-50, FENTANYL
FENTANYL-75, FENTANYL

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APPENDIX B

PRODUCT NAME SORTED BY APPLICANT


** L **

LEK PHARMS * LEK PHARMACEUTICALS D D AMOXICILLIN AND CLAVULANATE POTASSIUM, AMOXICILLIN BROMOCRIPTINE MESYLATE, BROMOCRIPTINE MESYLATE ENALAPRIL MALEATE, ENALAPRIL MALEATE LISINOPRIL, LISINOPRIL
OMEPRAZOLE, OMEPRAZOLE
LEK PHARMS DD * LEK PHARMACEUTICALS DD AMLODIPINE BESYLATE, AMLODIPINE BESYLATE AMOXICILLIN AND CLAVULANATE POTASSIUM, AMOXICILLIN PRAVASTATIN SODIUM, PRAVASTATIN SODIUM
ZOLPIDEM TARTRATE, ZOLPIDEM TARTRATE
LEO PHARM * LEO PHARMACEUTICAL PRODUCTS LTD DOVONEX, CALCIPOTRIENE
TACLONEX, BETAMETHASONE DIPROPIONATE
LEO PHARM PRODS * LEO PHARMACEUTICAL PRODUCTS LTD TACLONEX SCALP, BETAMETHASONE DIPROPIONATE LEO PHARMA AS * LEO PHARMA AS INNOHEP, TINZAPARIN SODIUM LG LIFE * LG LIFE SCIENCES LTD VALTROPIN, SOMATROPIN RECOMBINANT LILLY * ELI LILLY AND CO ALIMTA, PEMETREXED DISODIUM CIALIS, TADALAFIL CYMBALTA, DULOXETINE HYDROCHLORIDE EVISTA, RALOXIFENE HYDROCHLORIDE FORTEO, TERIPARATIDE RECOMBINANT HUMAN GEMZAR, GEMCITABINE HYDROCHLORIDE GLUCAGON, GLUCAGON RECOMBINANT HUMALOG KWIKPEN, INSULIN LISPRO RECOMBINANT HUMALOG MIX 50/50 KWIKPEN, INSULIN LISPRO PROTAMINE RECOMBINANT HUMALOG MIX 50/50, INSULIN LISPRO PROTAMINE RECOMBINANT HUMALOG MIX 75/25 KWIKPEN, INSULIN LISPRO PROTAMINE RECOMBINANT HUMALOG MIX 75/25, INSULIN LISPRO PROTAMINE RECOMBINANT HUMALOG PEN, INSULIN LISPRO RECOMBINANT HUMALOG, INSULIN LISPRO RECOMBINANT HUMATROPE, SOMATROPIN RECOMBINANT HUMULIN 70/30 PEN, INSULIN RECOMBINANT HUMAN (OTC) HUMULIN 70/30, INSULIN RECOMBINANT HUMAN (OTC) HUMULIN N, INSULIN SUSP ISOPHANE RECOMBINANT HUMAN (OTC) HUMULIN R PEN, INSULIN RECOMBINANT HUMAN (OTC) HUMULIN R, INSULIN RECOMBINANT HUMAN HUMULIN R, INSULIN RECOMBINANT HUMAN (OTC) PROZAC WEEKLY, FLUOXETINE HYDROCHLORIDE QUINIDINE GLUCONATE, QUINIDINE GLUCONATE STRATTERA, ATOMOXETINE HYDROCHLORIDE SYMBYAX, FLUOXETINE HYDROCHLORIDE ZYPREXA ZYDIS, OLANZAPINE
ZYPREXA, OLANZAPINE
* LILLY RESEARCH LABORATORIES DIV ELI LILLY AND CO PROZAC, FLUOXETINE HYDROCHLORIDE
SARAFEM, FLUOXETINE HYDROCHLORIDE
LLOYD * LLOYD INC LEVOTHROID,

LEVOTHYROXINE SODIUM

SEPTEMBER 2010 - APPROVED DRUG PRODUCTS LIST

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APPENDIX B

PRODUCT NAME SORTED BY APPLICANT


** L **

LNK * LNK INTERNATIONAL INC DOXYLAMINE SUCCINATE, DOXYLAMINE SUCCINATE (OTC) IBUPROFEN, IBUPROFEN (OTC)
LOPERAMIDE HYDROCHLORIDE, LOPERAMIDE HYDROCHLORIDE LOREAL USA * LOREAL USA PRODUCTS INC ANTHELIOS 20, AVOBENZONE (OTC) ANTHELIOS 40, AVOBENZONE (OTC) ANTHELIOS SX, AVOBENZONE (OTC)
CAPITAL SOLEIL 15, AVOBENZONE (OTC)

(OTC)

LUITPOLD * LUITPOLD PHARMACEUTICALS INC ACETYLCYSTEINE, ACETYLCYSTEINE ADENOSINE, ADENOSINE AMINOCAPROIC ACID, AMINOCAPROIC ACID AMINOPHYLLINE, AMINOPHYLLINE BETAMETHASONE ACETATE AND BETAMETHASONE SODIUM PHOSPHATE, BETAMETHASONE ACETATE BRETYLIUM TOSYLATE, BRETYLIUM TOSYLATE CAFFEINE CITRATE, CAFFEINE CITRATE CALCITRIOL, CALCITRIOL CEFTRIAXONE, CEFTRIAXONE SODIUM CYANOCOBALAMIN, CYANOCOBALAMIN DEXAMETHASONE SODIUM PHOSPHATE, DEXAMETHASONE SODIUM PHOSPHATE DEXFERRUM, IRON DEXTRAN DOPAMINE HYDROCHLORIDE, DOPAMINE HYDROCHLORIDE DROPERIDOL, DROPERIDOL FUROSEMIDE, FUROSEMIDE GLYCOPYRROLATE, GLYCOPYRROLATE HYDRALAZINE HYDROCHLORIDE, HYDRALAZINE HYDROCHLORIDE HYDROXYZINE HYDROCHLORIDE, HYDROXYZINE HYDROCHLORIDE KETOROLAC TROMETHAMINE, KETOROLAC TROMETHAMINE LEUCOVORIN CALCIUM PRESERVATIVE FREE, LEUCOVORIN CALCIUM LEVOCARNITINE, LEVOCARNITINE LIDOCAINE HYDROCHLORIDE, LIDOCAINE HYDROCHLORIDE MANNITOL 25%, MANNITOL METHYLDOPATE HYDROCHLORIDE, METHYLDOPATE HYDROCHLORIDE METOPROLOL TARTRATE, METOPROLOL TARTRATE NITROGLYCERIN, NITROGLYCERIN ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE, ONDANSETRON HYDROCHLORIDE ONDANSETRON HYDROCHLORIDE, ONDANSETRON HYDROCHLORIDE VENOFER, IRON SUCROSE
VERAPAMIL HYDROCHLORIDE, VERAPAMIL HYDROCHLORIDE
LUNDBECK INC * LUNDBECK INC CHEMET, SUCCIMER COGENTIN, BENZTROPINE MESYLATE COSMEGEN, DACTINOMYCIN DESOXYN, METHAMPHETAMINE HYDROCHLORIDE DIURIL, CHLOROTHIAZIDE SODIUM INDOCIN, INDOMETHACIN SODIUM MUSTARGEN, MECHLORETHAMINE HYDROCHLORIDE NEMBUTAL SODIUM, PENTOBARBITAL SODIUM NEOPROFEN, IBUPROFEN LYSINE PEGANONE, ETHOTOIN SABRIL, VIGABATRIN
TRANXENE, CLORAZEPATE DIPOTASSIUM
LUPIN * LUPIN LTD AMLODIPINE BESYLATE, AMLODIPINE BESYLATE CARVEDILOL, CARVEDILOL CEFADROXIL, CEFADROXIL/CEFADROXIL HEMIHYDRATE
CEFDINIR, CEFDINIR

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APPENDIX B

PRODUCT NAME SORTED BY APPLICANT


** L **

* LUPIN LTD CEFOTAXIME SODIUM, CEFOTAXIME SODIUM CEFPROZIL, CEFPROZIL CEFTRIAXONE, CEFTRIAXONE SODIUM CEFUROXIME AXETIL, CEFUROXIME AXETIL CEPHALEXIN, CEPHALEXIN DIVALPROEX SODIUM, DIVALPROEX SODIUM ETHAMBUTOL HYDROCHLORIDE, ETHAMBUTOL HYDROCHLORIDE LEVETIRACETAM, LEVETIRACETAM LISINOPRIL AND HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE LISINOPRIL, LISINOPRIL LOVASTATIN, LOVASTATIN QUINAPRIL HYDROCHLORIDE, QUINAPRIL HYDROCHLORIDE RAMIPRIL, RAMIPRIL SERTRALINE HYDROCHLORIDE, SERTRALINE HYDROCHLORIDE SIMVASTATIN, SIMVASTATIN SUPRAX, CEFIXIME
TRANDOLAPRIL, TRANDOLAPRIL
LUPIN ATLANTIS * LUPIN ATLANTIS HOLDINGS SA ANTARA (MICRONIZED), FENOFIBRATE LUPIN LTD * LUPIN LTD IMIPRAMINE HYDROCHLORIDE, IMIPRAMINE HYDROCHLORIDE
PERINDOPRIL ERBUMINE, PERINDOPRIL ERBUMINE
LUPIN PHARMS * LUPIN PHARMACEUTICALS INC AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE, MELOXICAM, MELOXICAM PRAVASTATIN SODIUM, PRAVASTATIN SODIUM
SUPRAX, CEFIXIME

AMLODIPINE BESYLATE

LYNE * LYNE LABORATORIES INC CALCITRIOL, CALCITRIOL CYPROHEPTADINE HYDROCHLORIDE, CYPROHEPTADINE HYDROCHLORIDE
LEVOCARNITINE, LEVOCARNITINE
MALLINCKRODT * MALLINCKRODT CHEMICAL INC ANEXSIA 7.5/650, ACETAMINOPHEN ANEXSIA, ACETAMINOPHEN BUTALBITAL, ACETAMINOPHEN AND CAFFEINE, ACETAMINOPHEN HYDROCODONE BITARTRATE AND ACETAMINOPHEN, ACETAMINOPHEN LORTAB, ACETAMINOPHEN METHADONE HYDROCHLORIDE, METHADONE HYDROCHLORIDE METHADOSE, METHADONE HYDROCHLORIDE
OXYCODONE AND ACETAMINOPHEN, ACETAMINOPHEN
* MALLINCKRODT INC ACETAMINOPHEN AND CODEINE PHOSPHATE, ACETAMINOPHEN ANEXSIA 5/325, ACETAMINOPHEN ANEXSIA 7.5/325, ACETAMINOPHEN ANEXSIA, ACETAMINOPHEN DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE, ASPARTATE DEXTROAMPHETAMINE SULFATE, DEXTROAMPHETAMINE SULFATE
FENTANYL CITRATE, FENTANYL CITRATE
FLUOXETINE HYDROCHLORIDE, FLUOXETINE HYDROCHLORIDE
HYDROCODONE BITARTRATE AND ACETAMINOPHEN, ACETAMINOPHEN
HYDROMORPHONE HYDROCHLORIDE, HYDROMORPHONE HYDROCHLORIDE
MEPERIDINE HYDROCHLORIDE, MEPERIDINE HYDROCHLORIDE
METHADONE HYDROCHLORIDE, METHADONE HYDROCHLORIDE
METHYLIN ER, METHYLPHENIDATE HYDROCHLORIDE
METHYLIN, METHYLPHENIDATE HYDROCHLORIDE
METHYLPHENIDATE HYDROCHLORIDE, METHYLPHENIDATE HYDROCHLORIDE

AMPHETAMINE

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APPENDIX B

PRODUCT NAME SORTED BY APPLICANT


** M **

* MALLINCKRODT INC MORPHINE SULFATE, MORPHINE SULFATE NALTREXONE HYDROCHLORIDE, NALTREXONE HYDROCHLORIDE OPTIMARK IN PLASTIC CONTAINER, GADOVERSETAMIDE OPTIMARK, GADOVERSETAMIDE OXYCET, ACETAMINOPHEN OXYCODONE AND ACETAMINOPHEN, ACETAMINOPHEN OXYCODONE HYDROCHLORIDE, OXYCODONE HYDROCHLORIDE SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, SODIUM CHLORIDE TECHNETIUM TC-99 SESTAMIBI, TECHNETIUM TC-99M SESTAMIBI KIT THALLOUS CHLORIDE TL 201, THALLOUS CHLORIDE TL-201
TRAMADOL HYDROCHLORIDE, TRAMADOL HYDROCHLORIDE
* MALLINCKRODT MEDICAL INC CONRAY 30, IOTHALAMATE MEGLUMINE CONRAY 43, IOTHALAMATE MEGLUMINE CONRAY, IOTHALAMATE MEGLUMINE CYSTO-CONRAY II, IOTHALAMATE MEGLUMINE GALLIUM CITRATE GA 67, GALLIUM CITRATE GA-67 INDIUM IN 111 CHLORIDE, INDIUM IN-111 CHLORIDE MD-76R, DIATRIZOATE MEGLUMINE MD-GASTROVIEW, DIATRIZOATE MEGLUMINE OCTREOSCAN, INDIUM IN-111 PENTETREOTIDE KIT OPTIRAY 160, IOVERSOL OPTIRAY 240, IOVERSOL OPTIRAY 300, IOVERSOL OPTIRAY 320, IOVERSOL OPTIRAY 350, IOVERSOL SODIUM IODIDE I 123, SODIUM IODIDE I-123 SODIUM IODIDE I 131, SODIUM IODIDE I-131 TECHNESCAN MAG3, TECHNETIUM TC-99M MERTIATIDE KIT TECHNESCAN PYP KIT, TECHNETIUM TC-99M PYROPHOSPHATE KIT TECHNESCAN, TECHNETIUM TC-99M OXIDRONATE KIT THALLOUS CHLORIDE TL 201, THALLOUS CHLORIDE TL-201 ULTRATAG, TECHNETIUM TC-99M RED BLOOD CELL KIT ULTRA-TECHNEKOW FM, TECHNETIUM TC-99M SODIUM PERTECHNETATE GENERATOR
XENON XE 133, XENON XE-133
MALLINCKRODT INC * MALLINCKRODT INC EXALGO, HYDROMORPHONE HYDROCHLORIDE MARKSANS PHARMA * MARKSANS PHARMA LTD IBUPROFEN, IBUPROFEN

(OTC)

MARSAM PHARMS LLC * MARSAM PHARMACEUTICALS LLC TOBRAMYCIN SULFATE, TOBRAMYCIN SULFATE MATRIX LABS INC * MATRIX LABORATORIES INC CITALOPRAM HYDROBROMIDE,

CITALOPRAM HYDROBROMIDE

MATRIX LABS LTD * MATRIX LABORATORIES LTD AMLODIPINE BESYLATE, AMLODIPINE BESYLATE BACLOFEN, BACLOFEN DIDANOSINE, DIDANOSINE LAMOTRIGINE, LAMOTRIGINE LANSOPRAZOLE, LANSOPRAZOLE SERTRALINE HYDROCHLORIDE, SERTRALINE HYDROCHLORIDE STAVUDINE, STAVUDINE TRAZODONE HYDROCHLORIDE, TRAZODONE HYDROCHLORIDE
ZIDOVUDINE, ZIDOVUDINE
MAYNE PHARMA INTL * MAYNE PHARMA INTERNATIONAL FAULDING PHARM DORYX, DOXYCYCLINE HYCLATE

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APPENDIX B

PRODUCT NAME SORTED BY APPLICANT

** M **

MCNEIL * MCNEIL CONSUMER PRODUCTS CO DIV MCNEILAB INC CHILDREN'S MOTRIN, IBUPROFEN (OTC) IBUPROFEN, IBUPROFEN (OTC) IMODIUM A-D EZ CHEWS, LOPERAMIDE HYDROCHLORIDE (OTC) IMODIUM MULTI-SYMPTOM RELIEF, LOPERAMIDE HYDROCHLORIDE MOTRIN IB, IBUPROFEN (OTC) MOTRIN MIGRAINE PAIN, IBUPROFEN (OTC)
ZYRTEC-D 12 HOUR, CETIRIZINE HYDROCHLORIDE (OTC)

(OTC)

MCNEIL CONS * MCNEIL CONSUMER HEALTHCARE BENADRYL PRESERVATIVE FREE, DIPHENHYDRAMINE HYDROCHLORIDE BENADRYL, DIPHENHYDRAMINE HYDROCHLORIDE CHILDREN'S MOTRIN COLD, IBUPROFEN (OTC) CHILDREN'S MOTRIN, IBUPROFEN (OTC) IMODIUM A-D, LOPERAMIDE HYDROCHLORIDE (OTC) IMODIUM MULTI-SYMPTOM RELIEF, LOPERAMIDE HYDROCHLORIDE (OTC) IMODIUM, LOPERAMIDE HYDROCHLORIDE JUNIOR STRENGTH MOTRIN, IBUPROFEN (OTC) NIZORAL A-D, KETOCONAZOLE (OTC) SINE-AID IB, IBUPROFEN (OTC) SUDAFED 12 HOUR, PSEUDOEPHEDRINE HYDROCHLORIDE (OTC) SUDAFED 24 HOUR, PSEUDOEPHEDRINE HYDROCHLORIDE (OTC) TYLENOL (CAPLET), ACETAMINOPHEN (OTC)
TYLENOL (GELTAB), ACETAMINOPHEN (OTC)
MCNEIL CONSUMER * MCNEIL CONSUMER HEALTHCARE DIV MCNEIL PPC INC CHILDREN'S ZYRTEC ALLERGY, CETIRIZINE HYDROCHLORIDE (OTC) CHILDREN'S ZYRTEC HIVES RELIEF, CETIRIZINE HYDROCHLORIDE (OTC) ZYRTEC ALLERGY, CETIRIZINE HYDROCHLORIDE (OTC) ZYRTEC HIVES RELIEF, CETIRIZINE HYDROCHLORIDE (OTC)
ZYRTEC, CETIRIZINE HYDROCHLORIDE
MCNEIL PED * MCNEIL PEDIATRICS FLEXERIL, CYCLOBENZAPRINE HYDROCHLORIDE MEAD JOHNSON * MEAD JOHNSON AND CO CAFCIT, CAFFEINE CITRATE MEDA PHARMS * MEDA PHARMACEUTICALS EDLUAR, ZOLPIDEM TARTRATE * MEDA PHARMACEUTICALS INC ASTELIN, AZELASTINE HYDROCHLORIDE ASTEPRO, AZELASTINE HYDROCHLORIDE BUTISOL SODIUM, BUTABARBITAL SODIUM CESAMET, NABILONE DEMADEX, TORSEMIDE DEPEN, PENICILLAMINE FELBATOL, FELBAMATE LUFYLLIN, DYPHYLLINE ONSOLIS, FENTANYL CITRATE
OPTIVAR, AZELASTINE HYDROCHLORIDE
* MEDA PHARMACEUTICALS MEDA PHARMACEUTICALS INC ASTEPRO, AZELASTINE HYDROCHLORIDE SOMA COMPOUND W/ CODEINE, ASPIRIN SOMA COMPOUND, ASPIRIN
SOMA, CARISOPRODOL
MEDICINES CO * THE MEDICINES CO ANGIOMAX, BIVALIRUDIN
CLEVIPREX, CLEVIDIPINE BUTYRATE

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APPENDIX B

PRODUCT NAME SORTED BY APPLICANT


** M **

MEDICIS * MEDICIS PHARMACEUTICAL CORP BUPHENYL, SODIUM PHENYLBUTYRATE DYNACIN, MINOCYCLINE HYDROCHLORIDE LIDEX, FLUOCINONIDE LIDEX-E, FLUOCINONIDE LOPROX, CICLOPIROX MINOCYCLINE HYDROCHLORIDE, MINOCYCLINE HYDROCHLORIDE SOLODYN, MINOCYCLINE HYDROCHLORIDE SYNACORT, HYDROCORTISONE SYNALAR, FLUOCINOLONE ACETONIDE VANOS, FLUOCINONIDE
ZIANA, CLINDAMYCIN PHOSPHATE
MEDICURE * MEDICURE INTERNATIONAL INC AGGRASTAT, TIROFIBAN HYDROCHLORIDE MEDIGENE * MEDIGENE INC VEREGEN, SINECATECHINS MEDIMMUNE * MEDIMMUNE ETHYOL,

AMIFOSTINE

MEDIVIR * MEDIVIR AB ACYCLOVIR AND HYDROCORTISONE, MEDTRONIC * MEDTRONIC INC LIORESAL, BACLOFEN

ACYCLOVIR

MERCK * MERCK AND CO INC AMINOHIPPURATE SODIUM, AMINOHIPPURATE SODIUM CANCIDAS, CASPOFUNGIN ACETATE EMEND, APREPITANT FOSAMAX PLUS D, ALENDRONATE SODIUM FOSAMAX, ALENDRONATE SODIUM HYZAAR, HYDROCHLOROTHIAZIDE INVANZ, ERTAPENEM SODIUM JANUMET, METFORMIN HYDROCHLORIDE MAXALT, RIZATRIPTAN BENZOATE MAXALT-MLT, RIZATRIPTAN BENZOATE PRIMAXIN, CILASTATIN SODIUM PROSCAR, FINASTERIDE SINGULAIR, MONTELUKAST SODIUM STROMECTOL, IVERMECTIN
ZOLINZA, VORINOSTAT
* MERCK RESEARCH LABORATORIES DIV MERCK CO INC CLINORIL, SULINDAC COSOPT, DORZOLAMIDE HYDROCHLORIDE COZAAR, LOSARTAN POTASSIUM MEVACOR, LOVASTATIN NOROXIN, NORFLOXACIN PEPCID AC (GELTAB), FAMOTIDINE (OTC) PEPCID AC, FAMOTIDINE (OTC) PEPCID COMPLETE, CALCIUM CARBONATE (OTC) PEPCID PRESERVATIVE FREE IN PLASTIC CONTAINER, PEPCID PRESERVATIVE FREE, FAMOTIDINE PEPCID, FAMOTIDINE PRINIVIL, LISINOPRIL PRINZIDE, HYDROCHLOROTHIAZIDE PROPECIA, FINASTERIDE SINGULAIR, MONTELUKAST SODIUM
TRUSOPT, DORZOLAMIDE HYDROCHLORIDE

FAMOTIDINE

SEPTEMBER 2010 - APPROVED DRUG PRODUCTS LIST

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APPENDIX B

PRODUCT NAME SORTED BY APPLICANT


** M **

* MERCK RESEARCH LABORATORIES DIV MERCK CO INC ZOCOR, SIMVASTATIN MERCK AND CO INC * MERCK AND CO INC EMEND, FOSAPREPITANT DIMEGLUMINE
FOSAMAX, ALENDRONATE SODIUM
MERCK CO INC * MERCK CO INC JANUVIA, SITAGLIPTIN PHOSPHATE MERCK KGAA * MERCK KGAA LEVOTHYROXINE SODIUM,

LEVOTHYROXINE SODIUM

MERCK SANTE SAS * MERCK SANTE SAS CYANOKIT, HYDROXOCOBALAMIN MERCK SHARP DOHME * MERCK SHARP AND DOHME CORP CRIXIVAN, INDINAVIR SULFATE
ISENTRESS, RALTEGRAVIR POTASSIUM
MERIDIAN MEDCL * MERIDIAN MEDICAL TECHNOLOGIES INC DUODOTE, ATROPINE MERIDIAN MEDCL TECHN * MERIDIAN MEDICAL TECHNOLOGIES INC ATROPEN, ATROPINE EPIPEN JR., EPINEPHRINE EPIPEN, EPINEPHRINE LIDOPEN, LIDOCAINE HYDROCHLORIDE MORPHINE SULFATE, MORPHINE SULFATE
PRALIDOXIME CHLORIDE, PRALIDOXIME CHLORIDE
MERZ PHARMS * MERZ PHARMACEUTICALS LLC ERYGEL, ERYTHROMYCIN
NAFTIN, NAFTIFINE HYDROCHLORIDE
METHAPHARM * METHAPHARM INC PROVOCHOLINE,

METHACHOLINE CHLORIDE

METRICS PHARM * METRICS PHARMACEUTICAL VENTURES LLC NOREPINEPHRINE BITARTRATE, NOREPINEPHRINE BITARTRATE MIDDLEBROOK PHARMS * MIDDLEBROOK PHARMACEUTICALS INC KEFLEX, CEPHALEXIN
MOXATAG, AMOXICILLIN
MIKAH PHARMA * MIKAH PHARMA LLC BETAXOLOL HYDROCHLORIDE, BETAXOLOL HYDROCHLORIDE GUANFACINE HYDROCHLORIDE, GUANFACINE HYDROCHLORIDE MEPERIDINE HYDROCHLORIDE, MEPERIDINE HYDROCHLORIDE
URSODIOL, URSODIOL
MIKART * MIKART INC ACETAMINOPHEN AND CODEINE PHOSPHATE, ACETAMINOPHEN ACETAMINOPHEN, ASPIRIN, AND CODEINE PHOSPHATE, ACETAMINOPHEN ACETAMINOPHEN, CAFFEINE, AND DIHYDROCODEINE BITARTRATE, ACETAMINOPHEN AMANTADINE HYDROCHLORIDE, AMANTADINE HYDROCHLORIDE AMINOCAPROIC ACID, AMINOCAPROIC ACID AMINOCAPROIC, AMINOCAPROIC ACID BENZONATATE, BENZONATATE
BUTALBITAL, ACETAMINOPHEN AND CAFFEINE, ACETAMINOPHEN

SEPTEMBER 2010 - APPROVED DRUG PRODUCTS LIST

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APPENDIX B

PRODUCT NAME SORTED BY APPLICANT


** M **

* MIKART INC BUTAPAP, ACETAMINOPHEN CARBINOXAMINE MALEATE, CARBINOXAMINE MALEATE DICYCLOMINE HYDROCHLORIDE, DICYCLOMINE HYDROCHLORIDE ERGOTAMINE TARTRATE AND CAFFEINE, CAFFEINE ESGIC-PLUS, ACETAMINOPHEN ETHOSUXIMIDE, ETHOSUXIMIDE HYDROCODONE BITARTRATE AND ACETAMINOPHEN, ACETAMINOPHEN ISONIAZID, ISONIAZID MEPERIDINE HYDROCHLORIDE, MEPERIDINE HYDROCHLORIDE METHAZOLAMIDE, METHAZOLAMIDE OXYBUTYNIN CHLORIDE, OXYBUTYNIN CHLORIDE OXYCODONE AND ACETAMINOPHEN, ACETAMINOPHEN PHENDIMETRAZINE TARTRATE, PHENDIMETRAZINE TARTRATE PYRAZINAMIDE, PYRAZINAMIDE
TRIHEXYPHENIDYL HYDROCHLORIDE, TRIHEXYPHENIDYL HYDROCHLORIDE
MILLENNIUM PHARMS * MILLENNIUM PHARMACEUTICALS INC VELCADE, BORTEZOMIB MISSION PHARMA * MISSION PHARMACAL CO LITHOSTAT, ACETOHYDROXAMIC ACID TINDAMAX, TINIDAZOLE TIOPRONIN, TIOPRONIN
UROCIT-K, POTASSIUM CITRATE
MN PHARMS * MN PHARMACEUTICALS PAMIDRONATE DISODIUM,

PAMIDRONATE DISODIUM

MONARCH PHARMS * MONARCH PHARMACEUTICALS INC CORTISPORIN, BACITRACIN ZINC CORTISPORIN, HYDROCORTISONE CORTISPORIN, HYDROCORTISONE ACETATE MENEST, ESTROGENS, ESTERIFIED NEOSPORIN G.U. IRRIGANT, NEOMYCIN SULFATE NEOSPORIN, GRAMICIDIN PEDIOTIC, HYDROCORTISONE SEPTRA DS, SULFAMETHOXAZOLE SEPTRA, SULFAMETHOXAZOLE THALITONE, CHLORTHALIDONE
VIROPTIC, TRIFLURIDINE
MORTON GROVE * MORTON GROVE ACQUISITION CORP CLEMASTINE FUMARATE, CLEMASTINE FUMARATE FLUOXETINE HYDROCHLORIDE, FLUOXETINE HYDROCHLORIDE MINOXIDIL EXTRA STRENGTH (FOR MEN), MINOXIDIL (OTC) OXYBUTYNIN CHLORIDE, OXYBUTYNIN CHLORIDE
PREDNISOLONE SODIUM PHOSPHATE, PREDNISOLONE SODIUM PHOSPHATE
* MORTON GROVE PHARMACEUTICALS INC ACETAMINOPHEN AND CODEINE PHOSPHATE, ACETAMINOPHEN ACETIC ACID, ACETIC ACID, GLACIAL ALBUTEROL SULFATE, ALBUTEROL SULFATE AMANTADINE HYDROCHLORIDE, AMANTADINE HYDROCHLORIDE AMOXICILLIN, AMOXICILLIN BROMFED-DM, BROMPHENIRAMINE MALEATE CARBAMAZEPINE, CARBAMAZEPINE CHLORHEXIDINE GLUCONATE, CHLORHEXIDINE GLUCONATE CIMETIDINE HYDROCHLORIDE, CIMETIDINE HYDROCHLORIDE CLINDAMYCIN PHOSPHATE, CLINDAMYCIN PHOSPHATE CLOBETASOL PROPIONATE, CLOBETASOL PROPIONATE CROMOLYN SODIUM, CROMOLYN SODIUM CYCLOSPORINE, CYCLOSPORINE
DEXAMETHASONE, DEXAMETHASONE

SEPTEMBER 2010 - APPROVED DRUG PRODUCTS LIST

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APPENDIX B

PRODUCT NAME SORTED BY APPLICANT


** M **

* MORTON GROVE PHARMACEUTICALS INC DEXCHLORPHENIRAMINE MALEATE, DEXCHLORPHENIRAMINE MALEATE DOXEPIN HYDROCHLORIDE, DOXEPIN HYDROCHLORIDE ERYTHROMYCIN, ERYTHROMYCIN FUROSEMIDE, FUROSEMIDE HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE, HOMATROPINE METHYLBROMIDE HYDROXYZINE HYDROCHLORIDE, HYDROXYZINE HYDROCHLORIDE LACTULOSE, LACTULOSE LIDOCAINE HYDROCHLORIDE, LIDOCAINE HYDROCHLORIDE LINDANE, LINDANE LITHIUM CITRATE, LITHIUM CITRATE LOPERAMIDE HYDROCHLORIDE, LOPERAMIDE HYDROCHLORIDE (OTC) LORATADINE, LORATADINE (OTC) MEGESTROL ACETATE, MEGESTROL ACETATE METAPROTERENOL SULFATE, METAPROTERENOL SULFATE METOCLOPRAMIDE HYDROCHLORIDE, METOCLOPRAMIDE HYDROCHLORIDE MINOXIDIL (FOR MEN), MINOXIDIL (OTC) NYSTATIN, NYSTATIN PREDNISOLONE SODIUM PHOSPHATE, PREDNISOLONE SODIUM PHOSPHATE PREDNISOLONE, PREDNISOLONE PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE, CODEINE PHOSPHATE PROMETHAZINE PLAIN, PROMETHAZINE HYDROCHLORIDE PROMETHAZINE W/ DEXTROMETHORPHAN, DEXTROMETHORPHAN HYDROBROMIDE SELENIUM SULFIDE, SELENIUM SULFIDE TRETINOIN, TRETINOIN TRIAMCINOLONE ACETONIDE, TRIAMCINOLONE ACETONIDE
VALPROIC ACID, VALPROIC ACID
MORTON GROVE PHARMS * MORTON GROVE PHARMACEUTICALS AMOXICILLIN AND CLAVULANATE POTASSIUM, * MORTON GROVE PHARMACEUTICALS INC GENERLAC, LACTULOSE MSP SINGAPORE * MSP SINGAPORE CO LLC VYTORIN, EZETIMIBE
ZETIA, EZETIMIBE
MURTY PHARMS * MURTY PHARMACEUTICALS INC DIPYRIDAMOLE, DIPYRIDAMOLE MUSTAFA NEVZAT * MUSTAFA NEVZAT ILAC SANAYII AS VECURONIUM BROMIDE, VECURONIUM BROMIDE MUTUAL PHARM * MUTUAL PHARMACEUTICAL CO INC ACETAZOLAMIDE, ACETAZOLAMIDE ALBUTEROL SULFATE, ALBUTEROL SULFATE ALLOPURINOL, ALLOPURINOL AMITRIPTYLINE HYDROCHLORIDE, AMITRIPTYLINE HYDROCHLORIDE ATENOLOL AND CHLORTHALIDONE, ATENOLOL ATENOLOL, ATENOLOL BACTRIM DS, SULFAMETHOXAZOLE BACTRIM, SULFAMETHOXAZOLE CARISOPRODOL, CARISOPRODOL CLONIDINE HYDROCHLORIDE, CLONIDINE HYDROCHLORIDE CYCLOBENZAPRINE HYDROCHLORIDE, CYCLOBENZAPRINE HYDROCHLORIDE DONEPEZIL HYDROCHLORIDE, DONEPEZIL HYDROCHLORIDE DOXYCYCLINE HYCLATE, DOXYCYCLINE HYCLATE DOXYCYCLINE, DOXYCYCLINE ERGOLOID MESYLATES, ERGOLOID MESYLATES FELODIPINE, FELODIPINE FOLIC ACID, FOLIC ACID HYDROXYZINE HYDROCHLORIDE, HYDROXYZINE HYDROCHLORIDE
IMIPRAMINE HYDROCHLORIDE, IMIPRAMINE HYDROCHLORIDE

AMOXICILLIN

SEPTEMBER 2010 - APPROVED DRUG PRODUCTS LIST

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APPENDIX B

PRODUCT NAME SORTED BY APPLICANT


** M **

* MUTUAL PHARMACEUTICAL CO INC LORAZEPAM, LORAZEPAM LOVASTATIN, LOVASTATIN METOCLOPRAMIDE HYDROCHLORIDE, METOCLOPRAMIDE HYDROCHLORIDE METOPROLOL TARTRATE, METOPROLOL TARTRATE METRONIDAZOLE, METRONIDAZOLE MINOXIDIL, MINOXIDIL NYSTATIN, NYSTATIN PHENTERMINE HYDROCHLORIDE, PHENTERMINE HYDROCHLORIDE PIROXICAM, PIROXICAM PREDNISONE, PREDNISONE PRIMIDONE, PRIMIDONE PROPAFENONE HYDROCHLORIDE, PROPAFENONE HYDROCHLORIDE QUINIDINE GLUCONATE, QUINIDINE GLUCONATE QUINIDINE SULFATE, QUINIDINE SULFATE SPIRONOLACTONE AND HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE SPIRONOLACTONE, SPIRONOLACTONE SULFAMETHOXAZOLE AND TRIMETHOPRIM, SULFAMETHOXAZOLE SULINDAC, SULINDAC TEMAZEPAM, TEMAZEPAM THIORIDAZINE HYDROCHLORIDE, THIORIDAZINE HYDROCHLORIDE TOLMETIN SODIUM, TOLMETIN SODIUM TRAMADOL HYDROCHLORIDE, TRAMADOL HYDROCHLORIDE
TRAZODONE HYDROCHLORIDE, TRAZODONE HYDROCHLORIDE
MUTUAL PHARMA * MUTUAL PHARMACAL CO DOXYCYCLINE HYCLATE, DOXYCYCLINE HYCLATE KETOCONAZOLE, KETOCONAZOLE METFORMIN HYDROCHLORIDE, METFORMIN HYDROCHLORIDE
TRIMETHOBENZAMIDE HYDROCHLORIDE, TRIMETHOBENZAMIDE HYDROCHLORIDE
MYLAN * MYLAN LABORATORIES INC ACYCLOVIR, ACYCLOVIR AMLODIPINE BESYLATE, AMLODIPINE BESYLATE ANAGRELIDE HYDROCHLORIDE, ANAGRELIDE HYDROCHLORIDE CAPTOPRIL, CAPTOPRIL ETODOLAC, ETODOLAC
TERAZOSIN HYDROCHLORIDE, TERAZOSIN HYDROCHLORIDE
* MYLAN PHARMACEUTICALS INC ACEBUTOLOL HYDROCHLORIDE, ACEBUTOLOL HYDROCHLORIDE ACYCLOVIR, ACYCLOVIR ALBUTEROL SULFATE, ALBUTEROL SULFATE ALENDRONATE SODIUM, ALENDRONATE SODIUM ALLOPURINOL, ALLOPURINOL ALPRAZOLAM, ALPRAZOLAM AMILORIDE HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE, AMILORIDE HYDROCHLORIDE AMIODARONE HYDROCHLORIDE, AMIODARONE HYDROCHLORIDE AMITRIPTYLINE HYDROCHLORIDE, AMITRIPTYLINE HYDROCHLORIDE ATENOLOL AND CHLORTHALIDONE, ATENOLOL ATENOLOL, ATENOLOL AZATHIOPRINE, AZATHIOPRINE AZITHROMYCIN, AZITHROMYCIN BACLOFEN, BACLOFEN BALSALAZIDE DISODIUM, BALSALAZIDE DISODIUM BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE, BENAZEPRIL HYDROCHLORIDE BENAZEPRIL HYDROCHLORIDE, BENAZEPRIL HYDROCHLORIDE BICALUTAMIDE, BICALUTAMIDE BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE, BISOPROLOL FUMARATE BISOPROLOL FUMARATE, BISOPROLOL FUMARATE BROMOCRIPTINE MESYLATE, BROMOCRIPTINE MESYLATE BUPROPION HYDROCHLORIDE, BUPROPION HYDROCHLORIDE BUSPIRONE HYDROCHLORIDE, BUSPIRONE HYDROCHLORIDE BUTORPHANOL TARTRATE, BUTORPHANOL TARTRATE
CAPTOPRIL AND HYDROCHLOROTHIAZIDE, CAPTOPRIL

SEPTEMBER 2010 - APPROVED DRUG PRODUCTS LIST

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APPENDIX B

PRODUCT NAME SORTED BY APPLICANT


** M **

* MYLAN PHARMACEUTICALS INC CARBIDOPA AND LEVODOPA, CARBIDOPA CARVEDILOL, CARVEDILOL CETIRIZINE HYDROCHLORIDE ALLERGY, CETIRIZINE HYDROCHLORIDE (OTC) CETIRIZINE HYDROCHLORIDE HIVES, CETIRIZINE HYDROCHLORIDE (OTC) CHLORDIAZEPOXIDE AND AMITRIPTYLINE HYDROCHLORIDE, AMITRIPTYLINE HYDROCHLORIDE CHLOROTHIAZIDE, CHLOROTHIAZIDE CHLORPROPAMIDE, CHLORPROPAMIDE CHLORTHALIDONE, CHLORTHALIDONE CILOSTAZOL, CILOSTAZOL CIMETIDINE, CIMETIDINE CIPROFLOXACIN EXTENDED RELEASE, CIPROFLOXACIN CIPROFLOXACIN HYDROCHLORIDE, CIPROFLOXACIN HYDROCHLORIDE CITALOPRAM HYDROBROMIDE, CITALOPRAM HYDROBROMIDE CLARITHROMYCIN, CLARITHROMYCIN CLOMIPRAMINE HYDROCHLORIDE, CLOMIPRAMINE HYDROCHLORIDE CLONAZEPAM, CLONAZEPAM CLONIDINE HYDROCHLORIDE, CLONIDINE HYDROCHLORIDE CLORAZEPATE DIPOTASSIUM, CLORAZEPATE DIPOTASSIUM CLORPRES, CHLORTHALIDONE CLOZAPINE, CLOZAPINE CYCLOBENZAPRINE HYDROCHLORIDE, CYCLOBENZAPRINE HYDROCHLORIDE CYSTAGON, CYSTEAMINE BITARTRATE DIAZEPAM, DIAZEPAM DICLOFENAC POTASSIUM, DICLOFENAC POTASSIUM DICLOFENAC SODIUM, DICLOFENAC SODIUM DICYCLOMINE HYDROCHLORIDE, DICYCLOMINE HYDROCHLORIDE DILTIAZEM HYDROCHLORIDE, DILTIAZEM HYDROCHLORIDE DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE, ATROPINE SULFATE DIVALPROEX SODIUM, DIVALPROEX SODIUM DOXAZOSIN MESYLATE, DOXAZOSIN MESYLATE DOXEPIN HYDROCHLORIDE, DOXEPIN HYDROCHLORIDE DOXYCYCLINE, DOXYCYCLINE ENALAPRIL MALEATE AND HYDROCHLOROTHIAZIDE, ENALAPRIL MALEATE ENALAPRIL MALEATE, ENALAPRIL MALEATE ESTRADIOL, ESTRADIOL ESTROPIPATE, ESTROPIPATE ETIDRONATE DISODIUM, ETIDRONATE DISODIUM ETOPOSIDE, ETOPOSIDE EXTENDED PHENYTOIN SODIUM, PHENYTOIN SODIUM FAMOTIDINE, FAMOTIDINE FELODIPINE, FELODIPINE FENOFIBRATE, FENOFIBRATE FENOPROFEN CALCIUM, FENOPROFEN CALCIUM FEXOFENADINE HYDROCHLORIDE, FEXOFENADINE HYDROCHLORIDE FINASTERIDE, FINASTERIDE FLUCONAZOLE, FLUCONAZOLE FLUOXETINE HYDROCHLORIDE, FLUOXETINE HYDROCHLORIDE FLUPHENAZINE HYDROCHLORIDE, FLUPHENAZINE HYDROCHLORIDE FLURAZEPAM HYDROCHLORIDE, FLURAZEPAM HYDROCHLORIDE FLURBIPROFEN, FLURBIPROFEN FLUVOXAMINE MALEATE, FLUVOXAMINE MALEATE FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE, FOSINOPRIL SODIUM FUROSEMIDE, FUROSEMIDE GALANTAMINE HYDROBROMIDE, GALANTAMINE HYDROBROMIDE GLIMEPIRIDE, GLIMEPIRIDE GLIPIZIDE AND METFORMIN HYDROCHLORIDE, GLIPIZIDE GLIPIZIDE, GLIPIZIDE GLYBURIDE (MICRONIZED), GLYBURIDE GRANISETRON HYDROCHLORIDE, GRANISETRON HYDROCHLORIDE GUANFACINE HYDROCHLORIDE, GUANFACINE HYDROCHLORIDE HALOPERIDOL, HALOPERIDOL HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE HYDROXYCHLOROQUINE SULFATE, HYDROXYCHLOROQUINE SULFATE
INDAPAMIDE, INDAPAMIDE

SEPTEMBER 2010 - APPROVED DRUG PRODUCTS LIST

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APPENDIX B

PRODUCT NAME SORTED BY APPLICANT


** M **

* MYLAN PHARMACEUTICALS INC INDOMETHACIN, INDOMETHACIN KETOCONAZOLE, KETOCONAZOLE KETOPROFEN, KETOPROFEN KETOROLAC TROMETHAMINE, KETOROLAC TROMETHAMINE LAMOTRIGINE, LAMOTRIGINE LETROZOLE, LETROZOLE LEVETIRACETAM, LEVETIRACETAM LEVOTHYROXINE SODIUM, LEVOTHYROXINE SODIUM LIOTHYRONINE SODIUM, LIOTHYRONINE SODIUM LISINOPRIL AND HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE LISINOPRIL, LISINOPRIL LOPERAMIDE HYDROCHLORIDE, LOPERAMIDE HYDROCHLORIDE LORATADINE, LORATADINE (OTC) LORAZEPAM, LORAZEPAM LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE LOVASTATIN, LOVASTATIN LOXAPINE SUCCINATE, LOXAPINE SUCCINATE MAPROTILINE HYDROCHLORIDE, MAPROTILINE HYDROCHLORIDE MECLOFENAMATE SODIUM, MECLOFENAMATE SODIUM MELOXICAM, MELOXICAM MERCAPTOPURINE, MERCAPTOPURINE METFORMIN HYDROCHLORIDE, METFORMIN HYDROCHLORIDE METHIMAZOLE, METHIMAZOLE METHOTREXATE SODIUM, METHOTREXATE SODIUM METHYCLOTHIAZIDE, METHYCLOTHIAZIDE METHYLDOPA AND HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE METHYLDOPA, METHYLDOPA METOLAZONE, METOLAZONE METOPROLOL TARTRATE AND HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE METOPROLOL TARTRATE, METOPROLOL TARTRATE MIDODRINE HYDROCHLORIDE, MIDODRINE HYDROCHLORIDE MIRTAZAPINE, MIRTAZAPINE MYCOPHENOLATE MOFETIL, MYCOPHENOLATE MOFETIL NADOLOL AND BENDROFLUMETHAZIDE, BENDROFLUMETHIAZIDE NADOLOL, NADOLOL NAPROXEN, NAPROXEN NICARDIPINE HYDROCHLORIDE, NICARDIPINE HYDROCHLORIDE NISOLDIPINE, NISOLDIPINE NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS), NITROFURANTOIN NITROFURANTOIN, NITROFURANTOIN, MACROCRYSTALLINE NIZATIDINE, NIZATIDINE NORTRIPTYLINE HYDROCHLORIDE, NORTRIPTYLINE HYDROCHLORIDE OMEPRAZOLE, OMEPRAZOLE ONDANSETRON HYDROCHLORIDE, ONDANSETRON HYDROCHLORIDE ONDANSETRON, ONDANSETRON OXYBUTYNIN CHLORIDE, OXYBUTYNIN CHLORIDE PACLITAXEL, PACLITAXEL PAROXETINE HYDROCHLORIDE, PAROXETINE HYDROCHLORIDE PEG 3350 AND ELECTROLYTES, POLYETHYLENE GLYCOL 3350 PEG-3350;POTASSIUM CHLORIDE;SODIUM BICARBONATE;SODIUM CHLORIDE, POLYETHYLENE GLYCOL 3350 PENTOXIFYLLINE, PENTOXIFYLLINE PERPHENAZINE AND AMITRIPTYLINE HYDROCHLORIDE, AMITRIPTYLINE HYDROCHLORIDE PHENYTEK, PHENYTOIN SODIUM PINDOLOL, PINDOLOL PIROXICAM, PIROXICAM POLYETHYLENE GLYCOL 3350, POLYETHYLENE GLYCOL 3350 (OTC) PRAMIPEXOLE DIHYDROCHLORIDE, PRAMIPEXOLE DIHYDROCHLORIDE PRAVASTATIN SODIUM, PRAVASTATIN SODIUM PRAZOSIN HYDROCHLORIDE, PRAZOSIN HYDROCHLORIDE PROBENECID, PROBENECID PROCHLORPERAZINE MALEATE, PROCHLORPERAZINE MALEATE PROPOXYPHENE HYDROCHLORIDE AND ACETAMINOPHEN, ACETAMINOPHEN PROPOXYPHENE HYDROCHLORIDE, PROPOXYPHENE HYDROCHLORIDE
PROPOXYPHENE NAPSYLATE AND ACETAMINOPHEN, ACETAMINOPHEN

SEPTEMBER 2010 - APPROVED DRUG PRODUCTS LIST

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APPENDIX B

PRODUCT NAME SORTED BY APPLICANT


** M **

* MYLAN PHARMACEUTICALS INC PROPRANOLOL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE PROPRANOLOL HYDROCHLORIDE, PROPRANOLOL HYDROCHLORIDE QUINAPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE QUINAPRIL HYDROCHLORIDE, QUINAPRIL HYDROCHLORIDE RISPERIDONE, RISPERIDONE ROPINIROLE HYDROCHLORIDE, ROPINIROLE HYDROCHLORIDE SELEGILINE HYDROCHLORIDE, SELEGILINE HYDROCHLORIDE SERTRALINE HYDROCHLORIDE, SERTRALINE HYDROCHLORIDE SOTALOL HYDROCHLORIDE, SOTALOL HYDROCHLORIDE SPIRONOLACTONE AND HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE SPIRONOLACTONE, SPIRONOLACTONE STAVUDINE, STAVUDINE SULINDAC, SULINDAC SUMATRIPTAN SUCCINATE, SUMATRIPTAN SUCCINATE TAMOXIFEN CITRATE, TAMOXIFEN CITRATE TEMAZEPAM, TEMAZEPAM TERBINAFINE HYDROCHLORIDE, TERBINAFINE HYDROCHLORIDE THIORIDAZINE HYDROCHLORIDE, THIORIDAZINE HYDROCHLORIDE THIOTHIXENE, THIOTHIXENE TIMOLOL MALEATE, TIMOLOL MALEATE TIZANIDINE HYDROCHLORIDE, TIZANIDINE HYDROCHLORIDE TOLAZAMIDE, TOLAZAMIDE TOLBUTAMIDE, TOLBUTAMIDE TOLMETIN SODIUM, TOLMETIN SODIUM TOPIRAMATE, TOPIRAMATE TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN, ACETAMINOPHEN TRAMADOL HYDROCHLORIDE, TRAMADOL HYDROCHLORIDE TRANDOLAPRIL, TRANDOLAPRIL TRIAMTERENE AND HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE TRIFLUOPERAZINE HYDROCHLORIDE, TRIFLUOPERAZINE HYDROCHLORIDE URSODIOL, URSODIOL VENLAFAXINE HYDROCHLORIDE, VENLAFAXINE HYDROCHLORIDE VERAPAMIL HYDROCHLORIDE, VERAPAMIL HYDROCHLORIDE WARFARIN SODIUM, WARFARIN SODIUM ZALEPLON, ZALEPLON ZOLPIDEM TARTRATE, ZOLPIDEM TARTRATE
ZONISAMIDE, ZONISAMIDE
MYLAN BERTEK * MYLAN BERTEK PHARMACEUTICALS INC AVITA, TRETINOIN MAXZIDE, HYDROCHLOROTHIAZIDE MAXZIDE-25, HYDROCHLOROTHIAZIDE MENTAX, BUTENAFINE HYDROCHLORIDE
MENTAX-TC, BUTENAFINE HYDROCHLORIDE
MYLAN TECHNOLOGIES * MYLAN TECHNOLOGIES INC ESTRADIOL, ESTRADIOL FENTANYL-100, FENTANYL FENTANYL-12, FENTANYL FENTANYL-25, FENTANYL FENTANYL-50, FENTANYL FENTANYL-75, FENTANYL
NITROGLYCERIN, NITROGLYCERIN
NATCO PHARMA * NATCO PHARMA LTD GRANISETRON HYDROCHLORIDE,

GRANISETRON HYDROCHLORIDE

NATCO PHARMA LTD * NATCO PHARMA LTD CITALOPRAM HYDROBROMIDE, CITALOPRAM HYDROBROMIDE
ONDANSETRON HYDROCHLORIDE, ONDANSETRON HYDROCHLORIDE

SEPTEMBER 2010 - APPROVED DRUG PRODUCTS LIST

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APPENDIX B

PRODUCT NAME SORTED BY APPLICANT


** N **

NAUTILUS NEUROSCIENC * NAUTILUS NEUROSCIENCES INC CAMBIA, DICLOFENAC POTASSIUM NAVINTA LLC * NAVINTA LLC FOMEPIZOLE, FOMEPIZOLE
NICARDIPINE HYDROCHLORIDE,

NICARDIPINE HYDROCHLORIDE

NEPHRON * NEPHRON CORP ALBUTEROL SULFATE, ALBUTEROL SULFATE


IPRATROPIUM BROMIDE, IPRATROPIUM BROMIDE
* NEPHRON PHARMACEUTICALS CORP ALBUTEROL SULFATE AND IPRATROPIUM BROMIDE, ALBUTEROL SULFATE ALBUTEROL SULFATE, ALBUTEROL SULFATE
METAPROTERENOL SULFATE, METAPROTERENOL SULFATE
NEUROGESX * NEUROGESX INC QUTENZA, CAPSAICIN NEUROSCI INC * NEUROSCI INC METFORMIN HYDROCHLORIDE,

METFORMIN HYDROCHLORIDE

NEW RIVER * NEW RIVER PHARMACEUTICALS INC PROFERDEX, IRON DEXTRAN NEXGEN PHARMA * NEXGEN PHARMA INC BUTALBITAL, ACETAMINOPHEN AND CAFFEINE, ACETAMINOPHEN CHENODIOL, CHENODIOL
POLYETHYLENE GLYCOL 3350, POLYETHYLENE GLYCOL 3350 (OTC)
NEXGEN PHARMA INC * NEXGEN PHARMA INC BUTALBITAL, ACETAMINOPHEN, CAFFEINE AND CODEINE PHOSPHATE, ACETAMINOPHEN BUTALBITAL, ASPIRIN, CAFFEINE, AND CODEINE PHOSPHATE, ASPIRIN
POLYETHYLENE GLYCOL 3350, POLYETHYLENE GLYCOL 3350
NEXUS PHARMS * NEXUS PHARMACEUTICALS INC BENZTROPINE MESYLATE, BENZTROPINE MESYLATE CIPROFLOXACIN HYDROCHLORIDE, CIPROFLOXACIN HYDROCHLORIDE
DICLOFENAC SODIUM, DICLOFENAC SODIUM
NITROMED * NITROMED INC BIDIL, HYDRALAZINE HYDROCHLORIDE NORTHSTAR HLTHCARE * NORTHSTAR HEALTHCARE HOLDINGS LTD ALLOPURINOL, ALLOPURINOL ATENOLOL, ATENOLOL BACLOFEN, BACLOFEN HYDROXYZINE HYDROCHLORIDE, HYDROXYZINE HYDROCHLORIDE IBUPROFEN, IBUPROFEN METOCLOPRAMIDE HYDROCHLORIDE, METOCLOPRAMIDE HYDROCHLORIDE
PROPRANOLOL HYDROCHLORIDE, PROPRANOLOL HYDROCHLORIDE
NOSTRUM * NOSTRUM PHARMACEUTICALS INC METFORMIN HYDROCHLORIDE, METFORMIN HYDROCHLORIDE
THEOPHYLLINE, THEOPHYLLINE
NOSTRUM LABS * NOSTRUM LABORATORIES INC DICLOFENAC SODIUM, DICLOFENAC SODIUM PIROXICAM, PIROXICAM
SUCRALFATE, SUCRALFATE

SEPTEMBER 2010 - APPROVED DRUG PRODUCTS LIST

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APPENDIX B

PRODUCT NAME SORTED BY APPLICANT


** N **

NOVADEL * NOVADEL PHARMA INC ZOLPIMIST, ZOLPIDEM TARTRATE NOVALAR * NOVALAR PHARMACEUTICALS INC ORAVERSE, PHENTOLAMINE MESYLATE NOVARTIS * NOVARTIS CONSUMER HEALTH INC DENAVIR, PENCICLOVIR SODIUM EXCEDRIN (MIGRAINE), ACETAMINOPHEN (OTC) HABITROL, NICOTINE (OTC) LAMISIL AT, TERBINAFINE (OTC) LAMISIL AT, TERBINAFINE HYDROCHLORIDE (OTC) LAMISIL, TERBINAFINE LAMISIL, TERBINAFINE HYDROCHLORIDE LAMISIL, TERBINAFINE HYDROCHLORIDE (OTC) NEXCEDE, KETOPROFEN (OTC) PREVACID 24 HR, LANSOPRAZOLE (OTC) TAVIST ALLERGY/SINUS/HEADACHE, ACETAMINOPHEN THRIVE, NICOTINE POLACRILEX (OTC) TRANSDERM SCOP, SCOPOLAMINE VAGISTAT-1, TIOCONAZOLE (OTC)
VOLTAREN, DICLOFENAC SODIUM
* NOVARTIS PHARMACEUTICALS CORP AFINITOR, EVEROLIMUS AREDIA, PAMIDRONATE DISODIUM CATAFLAM, DICLOFENAC POTASSIUM CLOZARIL, CLOZAPINE COARTEM, ARTEMETHER COMBIPATCH, ESTRADIOL DESFERAL, DEFEROXAMINE MESYLATE DIOVAN HCT, HYDROCHLOROTHIAZIDE DIOVAN, VALSARTAN ELIDEL, PIMECROLIMUS ENABLEX, DARIFENACIN HYDROBROMIDE ESTRADERM, ESTRADIOL EXELON, RIVASTIGMINE EXELON, RIVASTIGMINE TARTRATE EXFORGE HCT, AMLODIPINE EXFORGE, AMLODIPINE BESYLATE EXJADE, DEFERASIROX FAMVIR, FAMCICLOVIR FOCALIN XR, DEXMETHYLPHENIDATE HYDROCHLORIDE FOCALIN, DEXMETHYLPHENIDATE HYDROCHLORIDE FORADIL CERTIHALER, FORMOTEROL FUMARATE FORADIL, FORMOTEROL FUMARATE GLEEVEC, IMATINIB MESYLATE HYDERGINE, ERGOLOID MESYLATES LAMISIL, TERBINAFINE HYDROCHLORIDE LAMPRENE, CLOFAZIMINE LESCOL XL, FLUVASTATIN SODIUM LESCOL, FLUVASTATIN SODIUM LOPRESSOR HCT, HYDROCHLOROTHIAZIDE LOPRESSOR, METOPROLOL TARTRATE LOTENSIN HCT, BENAZEPRIL HYDROCHLORIDE LOTENSIN, BENAZEPRIL HYDROCHLORIDE LOTREL, AMLODIPINE BESYLATE METHERGINE, METHYLERGONOVINE MALEATE METOPIRONE, METYRAPONE MIACALCIN, CALCITONIN SALMON MIOCHOL-E, ACETYLCHOLINE CHLORIDE MYFORTIC, MYCOPHENOLIC ACID
NEORAL, CYCLOSPORINE

(OTC)

SEPTEMBER 2010 - APPROVED DRUG PRODUCTS LIST

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APPENDIX B

PRODUCT NAME SORTED BY APPLICANT


** N **

* NOVARTIS PHARMACEUTICALS CORP OCUPRESS, CARTEOLOL HYDROCHLORIDE PARLODEL, BROMOCRIPTINE MESYLATE RECLAST, ZOLEDRONIC ACID REGITINE, PHENTOLAMINE MESYLATE RITALIN LA, METHYLPHENIDATE HYDROCHLORIDE RITALIN, METHYLPHENIDATE HYDROCHLORIDE RITALIN-SR, METHYLPHENIDATE HYDROCHLORIDE SANDIMMUNE, CYCLOSPORINE SANDOSTATIN LAR, OCTREOTIDE ACETATE SANDOSTATIN, OCTREOTIDE ACETATE STARLIX, NATEGLINIDE TASIGNA, NILOTINIB HYDROCHLORIDE MONOHYDRATE TAVIST-1, CLEMASTINE FUMARATE (OTC) TEGRETOL, CARBAMAZEPINE TEGRETOL-XR, CARBAMAZEPINE TEKTURNA HCT, ALISKIREN HEMIFUMARATE TEKTURNA, ALISKIREN HEMIFUMARATE TRILEPTAL, OXCARBAZEPINE TYZEKA, TELBIVUDINE VALTURNA, ALISKIREN HEMIFUMARATE VASOCIDIN, PREDNISOLONE SODIUM PHOSPHATE VASOCON-A, ANTAZOLINE PHOSPHATE (OTC) VIVELLE, ESTRADIOL VIVELLE-DOT, ESTRADIOL VOLTAREN, DICLOFENAC SODIUM VOLTAREN-XR, DICLOFENAC SODIUM ZADITOR, KETOTIFEN FUMARATE (OTC)
ZOMETA, ZOLEDRONIC ACID
NOVARTIS PHARMS * NOVARTIS PHARMACEUTICALS CORP FEMARA, LETROZOLE
TOBI, TOBRAMYCIN
NOVEL LABS INC * NOVEL LABORATORIES INC PEG 3350 AND ELECTROLYTES, POLYETHYLENE GLYCOL 3350 PEG-3350;POTASSIUM CHLORIDE;SODIUM BICARBONATE;SODIUM CHLORIDE, POLYETHYLENE GLYCOL 3350, POLYETHYLENE GLYCOL 3350 (OTC)
TEMAZEPAM, TEMAZEPAM
NOVEN * NOVEN PHARMACEUTICALS INC FENTANYL-100, FENTANYL FENTANYL-25, FENTANYL FENTANYL-50, FENTANYL
FENTANYL-75, FENTANYL
NOVEN THERAP * NOVEN THERAPEUTICS LLC LITHOBID, LITHIUM CARBONATE
PEXEVA, PAROXETINE MESYLATE
NOVEX * NOVEX PHARMA ALBUTEROL SULFATE, ALBUTEROL SULFATE BETAXOLOL HYDROCHLORIDE, BETAXOLOL HYDROCHLORIDE BUTORPHANOL TARTRATE, BUTORPHANOL TARTRATE CARTEOLOL HYDROCHLORIDE, CARTEOLOL HYDROCHLORIDE CHLORHEXIDINE GLUCONATE, CHLORHEXIDINE GLUCONATE CIMETIDINE HYDROCHLORIDE, CIMETIDINE HYDROCHLORIDE CIPROFLOXACIN HYDROCHLORIDE, CIPROFLOXACIN HYDROCHLORIDE CLEMASTINE FUMARATE, CLEMASTINE FUMARATE CROMOLYN SODIUM, CROMOLYN SODIUM CYCLOSPORINE, CYCLOSPORINE FLUOXETINE HYDROCHLORIDE, FLUOXETINE HYDROCHLORIDE
IPRATROPIUM BROMIDE, IPRATROPIUM BROMIDE

POLYETHYLENE GLYCOL 3350

SEPTEMBER 2010 - APPROVED DRUG PRODUCTS LIST

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APPENDIX B

PRODUCT NAME SORTED BY APPLICANT


** N **

* NOVEX PHARMA LACTULOSE, LACTULOSE LEVOBUNOLOL HYDROCHLORIDE, LEVOBUNOLOL HYDROCHLORIDE METAPROTERENOL SULFATE, METAPROTERENOL SULFATE MINOXIDIL (FOR MEN), MINOXIDIL (OTC) MINOXIDIL (FOR WOMEN), MINOXIDIL (OTC) MINOXIDIL EXTRA STRENGTH (FOR MEN), MINOXIDIL (OTC) OFLOXACIN, OFLOXACIN OXYBUTYNIN CHLORIDE, OXYBUTYNIN CHLORIDE TIMOLOL MALEATE, TIMOLOL MALEATE
TOBRAMYCIN, TOBRAMYCIN
NOVO NORDISK * NOVO NORDISK PHARMACEUTICALS INC GLUCAGEN, GLUCAGON HYDROCHLORIDE RECOMBINANT NOVO NORDISK INC * NOVO NORDISK INC ACTIVELLA, ESTRADIOL LEVEMIR, INSULIN DETEMIR RECOMBINANT NORDITROPIN FLEXPRO, SOMATROPIN RECOMBINANT NORDITROPIN NORDIFLEX, SOMATROPIN RECOMBINANT NORDITROPIN, SOMATROPIN RECOMBINANT NOVOLIN 70/30, INSULIN RECOMBINANT HUMAN (OTC) NOVOLIN N, INSULIN SUSP ISOPHANE RECOMBINANT HUMAN (OTC) NOVOLIN R, INSULIN RECOMBINANT HUMAN (OTC) NOVOLOG MIX 70/30, INSULIN ASPART PROTAMINE RECOMBINANT NOVOLOG, INSULIN ASPART RECOMBINANT PRANDIMET, METFORMIN HYDROCHLORIDE PRANDIN, REPAGLINIDE VAGIFEM, ESTRADIOL
VICTOZA, LIRAGLUTIDE RECOMBINANT
NOVOCOL * NOVOCOL PHARMACEUTICAL INC ISOCAINE HYDROCHLORIDE W/ LEVONORDEFRIN, LEVONORDEFRIN
ISOCAINE HYDROCHLORIDE, MEPIVACAINE HYDROCHLORIDE
NU PHARM * NU PHARM INC DIVALPROEX SODIUM,

DIVALPROEX SODIUM

NUTRITIONAL RESTART * NUTRITIONAL RESTART PHARMACEUTICAL LP NUTRESTORE, GLUTAMINE NUVO RES * NUVO RESEARCH INC PENNSAID, DICLOFENAC SODIUM NYCOMED US * NYCOMED US INC ALVESCO, CICLESONIDE CALCIPOTRIENE, CALCIPOTRIENE CARMOL HC, HYDROCORTISONE ACETATE CICLOPIROX, CICLOPIROX CLINDAMYCIN PHOSPHATE, CLINDAMYCIN PHOSPHATE CLOBETASOL PROPIONATE, CLOBETASOL PROPIONATE CLOTRIMAZOLE, CLOTRIMAZOLE CUTIVATE, FLUTICASONE PROPIONATE IMIQUIMOD, IMIQUIMOD LIDOCAINE AND PRILOCAINE, LIDOCAINE MOMETASONE FUROATE, MOMETASONE FUROATE OMNARIS, CICLESONIDE PAMINE FORTE, METHSCOPOLAMINE BROMIDE PAMINE, METHSCOPOLAMINE BROMIDE SOLARAZE, DICLOFENAC SODIUM TERCONAZOLE, TERCONAZOLE
TYZINE, TETRAHYDROZOLINE HYDROCHLORIDE

SEPTEMBER 2010 - APPROVED DRUG PRODUCTS LIST

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APPENDIX B

PRODUCT NAME SORTED BY APPLICANT


** N **

* NYCOMED US INC ZONALON, DOXEPIN HYDROCHLORIDE ODYSSEY PHARMS * ODYSSEY PHARMACEUTICALS INC ANTABUSE, DISULFIRAM NYSTATIN, NYSTATIN SURMONTIL, TRIMIPRAMINE MALEATE URECHOLINE, BETHANECHOL CHLORIDE
VIVACTIL, PROTRIPTYLINE HYDROCHLORIDE
OHM * OHM CORP IBUPROFEN,

IBUPROFEN

(OTC)

OHM LABS * OHM LABORATORIES INC ACETAMINOPHEN, ACETAMINOPHEN (OTC) CHLOROQUINE PHOSPHATE, CHLOROQUINE PHOSPHATE CHLORZOXAZONE, CHLORZOXAZONE IBUPROFEN, IBUPROFEN IBUPROHM COLD AND SINUS, IBUPROFEN (OTC) IBUPROHM, IBUPROFEN IBUPROHM, IBUPROFEN (OTC)
LOPERAMIDE HYDROCHLORIDE, LOPERAMIDE HYDROCHLORIDE OLTA PHARMS * OLTA PHARMACEUTICALS CORP LINDANE, LINDANE OMAN PHARM PRODUCTS * OMAN PHARMACEUTICAL PRODUCTS CO LLC NEOMYCIN SULFATE, NEOMYCIN SULFATE ONY * ONY INC INFASURF PRESERVATIVE FREE,

(OTC)

CALFACTANT

ORAPHARMA * ORAPHARMA INC ARESTIN, MINOCYCLINE HYDROCHLORIDE ORCHID HLTHCARE * ORCHID HEALTHCARE AMLODIPINE BESYLATE, AMLODIPINE BESYLATE CEFADROXIL, CEFADROXIL/CEFADROXIL HEMIHYDRATE CEFAZOLIN SODIUM, CEFAZOLIN SODIUM CEFDINIR, CEFDINIR CEFEPIME HYDROCHLORIDE, CEFEPIME HYDROCHLORIDE CEFOTAXIME SODIUM, CEFOTAXIME SODIUM CEFOXITIN, CEFOXITIN SODIUM CEFPODOXIME PROXETIL, CEFPODOXIME PROXETIL CEFPROZIL, CEFPROZIL CEFTRIAXONE, CEFTRIAXONE SODIUM CEFUROXIME AXETIL, CEFUROXIME AXETIL CEFUROXIME SODIUM, CEFUROXIME SODIUM CEPHALEXIN, CEPHALEXIN CETIRIZINE HYDROCHLORIDE ALLERGY, CETIRIZINE HYDROCHLORIDE (OTC) CETIRIZINE HYDROCHLORIDE HIVES, CETIRIZINE HYDROCHLORIDE (OTC) DESLORATADINE, DESLORATADINE DIVALPROEX SODIUM, DIVALPROEX SODIUM GRANISETRON HYDROCHLORIDE, GRANISETRON HYDROCHLORIDE LEVETIRACETAM, LEVETIRACETAM PIPERACILLIN AND TAZOBACTAM, PIPERACILLIN SODIUM SUMATRIPTAN SUCCINATE, SUMATRIPTAN SUCCINATE
TERBINAFINE HYDROCHLORIDE, TERBINAFINE HYDROCHLORIDE
* ORCHID HEALTHCARE DIV ORCHID CHEMICALS AND PHARMACEUTICALS LTD ZALEPLON, ZALEPLON

SEPTEMBER 2010 - APPROVED DRUG PRODUCTS LIST

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APPENDIX B

PRODUCT NAME SORTED BY APPLICANT


** O **

ORGANON USA INC * ORGANON USA INC CYCLESSA, DESOGESTREL DESOGEN, DESOGESTREL FOLLISTIM AQ, FOLLITROPIN ALFA/BETA GANIRELIX ACETATE INJECTION, GANIRELIX ACETATE IMPLANON, ETONOGESTREL NUVARING, ETHINYL ESTRADIOL PREGNYL, GONADOTROPIN, CHORIONIC REMERON SOLTAB, MIRTAZAPINE REMERON, MIRTAZAPINE
SAPHRIS, ASENAPINE MALEATE
ORION * ORION CORP COMTAN, ENTACAPONE STALEVO 100, CARBIDOPA STALEVO 125, CARBIDOPA STALEVO 150, CARBIDOPA STALEVO 200, CARBIDOPA STALEVO 50, CARBIDOPA
STALEVO 75, CARBIDOPA
ORIT LABS LLC * ORIT LABORATORIES LLC BENZONATATE, BENZONATATE CYCLOBENZAPRINE HYDROCHLORIDE, CYCLOBENZAPRINE HYDROCHLORIDE
ERGOCALCIFEROL, ERGOCALCIFEROL
ORPHAN EUROPE * ORPHAN EUROPE CARBAGLU, CARGLUMIC ACID ORTHO BIOTECH * ORTHO BIOTECH PRODUCTS LP DOXIL, DOXORUBICIN HYDROCHLORIDE
LEUSTATIN, CLADRIBINE
ORTHO DERMATOLOGICS * ORTHO DERMATOLOGICS ERTACZO, SERTACONAZOLE NITRATE RENOVA, TRETINOIN
RETIN-A MICRO, TRETINOIN
ORTHO MCNEIL JANSSEN * ORTHO MCNEIL JANSSEN PHARMACEUTICAL INC CONCERTA, METHYLPHENIDATE HYDROCHLORIDE DORIBAX, DORIPENEM HALDOL, HALOPERIDOL DECANOATE RAZADYNE, GALANTAMINE HYDROBROMIDE RISPERDAL, RISPERIDONE TERAZOL 3, TERCONAZOLE TYLENOL W/ CODEINE NO. 3, ACETAMINOPHEN TYLENOL W/ CODEINE NO. 4, ACETAMINOPHEN TYLOX, ACETAMINOPHEN
ULTRACET, ACETAMINOPHEN
* ORTHO MCNEIL JANSSEN PHARMACEUTICALS INC AXERT, ALMOTRIPTAN MALATE DITROPAN XL, OXYBUTYNIN CHLORIDE DITROPAN, OXYBUTYNIN CHLORIDE DURAGESIC-100, FENTANYL DURAGESIC-12, FENTANYL DURAGESIC-25, FENTANYL DURAGESIC-50, FENTANYL DURAGESIC-75, FENTANYL ELMIRON, PENTOSAN POLYSULFATE SODIUM INVEGA, PALIPERIDONE
LEVAQUIN, LEVOFLOXACIN

SEPTEMBER 2010 - APPROVED DRUG PRODUCTS LIST

B - 90

APPENDIX B

PRODUCT NAME SORTED BY APPLICANT


** O **

* ORTHO MCNEIL JANSSEN PHARMACEUTICALS INC MICRONOR, NORETHINDRONE MODICON 28, ETHINYL ESTRADIOL NIZORAL, KETOCONAZOLE NUCYNTA, TAPENTADOL HYDROCHLORIDE ORTHO CYCLEN-28, ETHINYL ESTRADIOL ORTHO EVRA, ETHINYL ESTRADIOL ORTHO TRI-CYCLEN LO, ETHINYL ESTRADIOL ORTHO TRI-CYCLEN, ETHINYL ESTRADIOL ORTHO-CEPT, DESOGESTREL ORTHO-NOVUM 1/35-28, ETHINYL ESTRADIOL ORTHO-NOVUM 7/7/7-28, ETHINYL ESTRADIOL PARAFON FORTE DSC, CHLORZOXAZONE RAZADYNE ER, GALANTAMINE HYDROBROMIDE RAZADYNE, GALANTAMINE HYDROBROMIDE RISPERDAL CONSTA, RISPERIDONE RISPERDAL, RISPERIDONE SPORANOX, ITRACONAZOLE TERAZOL 3, TERCONAZOLE TERAZOL 7, TERCONAZOLE TOLECTIN 600, TOLMETIN SODIUM TOLECTIN DS, TOLMETIN SODIUM TOLECTIN, TOLMETIN SODIUM TOPAMAX, TOPIRAMATE ULTRAM, TRAMADOL HYDROCHLORIDE
URISPAS, FLAVOXATE HYDROCHLORIDE
ORTHO MCNEIL PHARM * ORTHO MCNEIL PHARMACEUTICAL INC LEVAQUIN IN DEXTROSE 5% IN PLASTIC CONTAINER, LEVAQUIN, LEVOFLOXACIN
ORTHONEUTROGENA * ORTHONEUTROGENA GRIFULVIN V, GRISEOFULVIN, MICROCRYSTALLINE OSCIENT * OSCIENT PHARMACEUTICALS FACTIVE, GEMIFLOXACIN MESYLATE OSI PHARMS * OSI PHARMACEUTICALS INC TARCEVA, ERLOTINIB HYDROCHLORIDE OSMOTICA PHARM * OSMOTICA PHARMACEUTICAL CORP NIFEDIPINE, NIFEDIPINE OXYBUTYNIN CHLORIDE, OXYBUTYNIN CHLORIDE
VENLAFAXINE HYDROCHLORIDE, VENLAFAXINE HYDROCHLORIDE
OTSUKA * OTSUKA PHARMACEUTICAL CO LTD ABILIFY, ARIPIPRAZOLE
PLETAL, CILOSTAZOL
* OTSUKA PHARMACEUTICAL DEVELOPMENT AND COMMERCIALIZATION INC ABILIFY, ARIPIPRAZOLE OTSUKA AMERICA * OTSUKA AMERICA PHARMACEUTICALS INC BREATHTEK UBT FOR H-PYLORI, UREA C-13 OTSUKA AMERICA PHARM * OTSUKA AMERICA PHARMACEUTICAL INC SAMSCA, TOLVAPTAN OTSUKA PHARM * OTSUKA PHARMACEUTICAL CO LTD BUSULFEX, BUSULFAN

LEVOFLOXACIN

SEPTEMBER 2010 - APPROVED DRUG PRODUCTS LIST

B - 91

APPENDIX B
OUTLOOK PHARMS * OUTLOOK PHARMACEUTICALS INC DEXTROAMPHETAMINE SULFATE, PACIFIC PHARMA * PACIFIC PHARMA TIMOLOL MALEATE, * PACIFIC PHARMA INC TIMOLOL MALEATE,

PRODUCT NAME SORTED BY APPLICANT


** O **

DEXTROAMPHETAMINE SULFATE

TIMOLOL MALEATE TIMOLOL MALEATE

PACIRA PHARMS INC * PACIRA PHARMACEUTICALS INC DEPOCYT, CYTARABINE


DEPODUR, MORPHINE SULFATE
PADDOCK * PADDOCK LABORATORIES INC AMMONIUM LACTATE, AMMONIUM LACTATE BENZPHETAMINE HYDROCHLORIDE, BENZPHETAMINE HYDROCHLORIDE BROMOCRIPTINE MESYLATE, BROMOCRIPTINE MESYLATE CICLOPIROX, CICLOPIROX CLINDA-DERM, CLINDAMYCIN PHOSPHATE CLOTRIMAZOLE, CLOTRIMAZOLE COLISTIMETHATE SODIUM, COLISTIMETHATE SODIUM COLOCORT, HYDROCORTISONE COMPRO, PROCHLORPERAZINE DIHYDROERGOTAMINE MESYLATE, DIHYDROERGOTAMINE MESYLATE ERYTHRA-DERM, ERYTHROMYCIN FLAVOXATE HYDROCHLORIDE, FLAVOXATE HYDROCHLORIDE KIONEX, SODIUM POLYSTYRENE SULFONATE LAX-LYTE WITH FLAVOR PACKS, POLYETHYLENE GLYCOL 3350 MIDAZOLAM HYDROCHLORIDE, MIDAZOLAM HYDROCHLORIDE MOEXIPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE MOEXIPRIL HYDROCHLORIDE, MOEXIPRIL HYDROCHLORIDE NYSTOP, NYSTATIN PODOFILOX, PODOFILOX POLYETHYLENE GLYCOL 3350, POLYETHYLENE GLYCOL 3350 POLYETHYLENE GLYCOL 3350, POLYETHYLENE GLYCOL 3350 (OTC) PREDNISOLONE SODIUM PHOSPHATE, PREDNISOLONE SODIUM PHOSPHATE PROMETHAZINE HYDROCHLORIDE, PROMETHAZINE HYDROCHLORIDE TESTOSTERONE CYPIONATE, TESTOSTERONE CYPIONATE
TESTOSTERONE ENANTHATE, TESTOSTERONE ENANTHATE
PADDOCK LABS * PADDOCK LABORATORIES INC CAFFEINE CITRATE, CAFFEINE CITRATE CICLOPIROX, CICLOPIROX LORAZEPAM, LORAZEPAM MIDAMOR, AMILORIDE HYDROCHLORIDE
POLYETHYLENE GLYCOL 3350 AND ELECTROLYTES, PALADIN LABS * PALADIN LABS USA INC ANTIZOL, FOMEPIZOLE PAR PHARM * PAR PHARMACEUTICAL NABUMETONE, NABUMETONE PROPRANOLOL HYDROCHLORIDE, PROPRANOLOL HYDROCHLORIDE SUMYCIN, TETRACYCLINE HYDROCHLORIDE
TRAMADOL HYDROCHLORIDE, TRAMADOL HYDROCHLORIDE
* PAR PHARMACEUTICAL INC AMILORIDE HYDROCHLORIDE, AMILORIDE HYDROCHLORIDE CABERGOLINE, CABERGOLINE CALCITONIN-SALMON, CALCITONIN SALMON CAPOTEN, CAPTOPRIL CARISOPRODOL AND ASPIRIN, ASPIRIN
CHOLESTYRAMINE LIGHT, CHOLESTYRAMINE

POLYETHYLENE GLYCOL 3350

SEPTEMBER 2010 - APPROVED DRUG PRODUCTS LIST

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APPENDIX B

PRODUCT NAME SORTED BY APPLICANT


** P **

* PAR PHARMACEUTICAL INC CHOLESTYRAMINE, CHOLESTYRAMINE CLOMIPHENE CITRATE, CLOMIPHENE CITRATE CYPROHEPTADINE HYDROCHLORIDE, CYPROHEPTADINE HYDROCHLORIDE DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE, ATROPINE SULFATE DOXEPIN HYDROCHLORIDE, DOXEPIN HYDROCHLORIDE DOXYCYCLINE, DOXYCYCLINE ESTAZOLAM, ESTAZOLAM FLUTAMIDE, FLUTAMIDE HYDRALAZINE HYDROCHLORIDE, HYDRALAZINE HYDROCHLORIDE HYDRA-ZIDE, HYDRALAZINE HYDROCHLORIDE HYDROFLUMETHIAZIDE, HYDROFLUMETHIAZIDE HYDROXYUREA, HYDROXYUREA IBUPROFEN, IBUPROFEN (OTC) IMIPRAMINE HYDROCHLORIDE, IMIPRAMINE HYDROCHLORIDE ISOSORBIDE DINITRATE, ISOSORBIDE DINITRATE MECLIZINE HYDROCHLORIDE, MECLIZINE HYDROCHLORIDE MEGACE ES, MEGESTROL ACETATE MEGESTROL ACETATE, MEGESTROL ACETATE METAPROTERENOL SULFATE, METAPROTERENOL SULFATE MINOXIDIL, MINOXIDIL NASCOBAL, CYANOCOBALAMIN NATEGLINIDE, NATEGLINIDE RANITIDINE HYDROCHLORIDE, RANITIDINE HYDROCHLORIDE RISPERIDONE, RISPERIDONE SULFAMETHOPRIM, SULFAMETHOXAZOLE SULFAMETHOPRIM-DS, SULFAMETHOXAZOLE SUMATRIPTAN SUCCINATE, SUMATRIPTAN SUCCINATE SUMYCIN, TETRACYCLINE HYDROCHLORIDE
TORSEMIDE, TORSEMIDE
PARENTA PHARMS * PARENTA PHARMACEUTICALS INC ETOMIDATE, ETOMIDATE PARKE DAVIS * PARKE DAVIS DIV WARNER LAMBERT CO CELONTIN, METHSUXIMIDE CEREBYX, FOSPHENYTOIN SODIUM DILANTIN, PHENYTOIN SODIUM DILANTIN-125, PHENYTOIN NARDIL, PHENELZINE SULFATE NEURONTIN, GABAPENTIN
ZARONTIN, ETHOSUXIMIDE
* PARKE DAVIS PHARMACEUTICAL RESEARCH DIV WARNER LAMBERT CO ZARONTIN, ETHOSUXIMIDE PAV NOVA * PAV NOVA INC TODAY, NONOXYNOL-9

(OTC)

PEDINOL * PEDINOL PHARMACAL INC GRIS-PEG, GRISEOFULVIN, ULTRAMICROCRYSTALLINE


NALFON, FENOPROFEN CALCIUM
PERRIGO * L PERRIGO CO ACETAMINOPHEN, ACETAMINOPHEN (OTC) ACETAMINOPHEN, ASPIRIN AND CAFFEINE, ACETAMINOPHEN (OTC) CHILDREN'S IBUPROFEN, IBUPROFEN (OTC) CROMOLYN SODIUM, CROMOLYN SODIUM (OTC) DOXYLAMINE SUCCINATE, DOXYLAMINE SUCCINATE (OTC) FAMOTIDINE, FAMOTIDINE (OTC) IBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE, IBUPROFEN (OTC) IBUPROFEN, IBUPROFEN (OTC) LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE, LOPERAMIDE HYDROCHLORIDE LOPERAMIDE HYDROCHLORIDE, LOPERAMIDE HYDROCHLORIDE (OTC)

(OTC)

SEPTEMBER 2010 - APPROVED DRUG PRODUCTS LIST

B - 93

APPENDIX B

PRODUCT NAME SORTED BY APPLICANT


** P **

* L PERRIGO CO LORATADINE, LORATADINE (OTC) MICONAZOLE 3 COMBINATION PACK, MICONAZOLE NITRATE (OTC) MICONAZOLE NITRATE, MICONAZOLE NITRATE (OTC) MINOXIDIL EXTRA STRENGTH (FOR MEN), MINOXIDIL (OTC) NAPROXEN SODIUM AND PSEUDOEPHEDRINE HYDROCHLORIDE, NAPROXEN SODIUM (OTC) NAPROXEN SODIUM, NAPROXEN SODIUM (OTC) RANITIDINE HYDROCHLORIDE, RANITIDINE HYDROCHLORIDE (OTC) TAB-PROFEN, IBUPROFEN (OTC)
TIOCONAZOLE, TIOCONAZOLE (OTC)
* PERRIGO CO CICLOPIROX, CICLOPIROX CIMETIDINE, CIMETIDINE (OTC) CLEMASTINE FUMARATE, CLEMASTINE FUMARATE (OTC) CLINDETS, CLINDAMYCIN PHOSPHATE CLOBETASOL PROPIONATE, CLOBETASOL PROPIONATE ERYTHROMYCIN, ERYTHROMYCIN FAMOTIDINE, FAMOTIDINE FAMOTIDINE, FAMOTIDINE (OTC) HALOBETASOL PROPIONATE, HALOBETASOL PROPIONATE IBUPROFEN, IBUPROFEN (OTC) JUNIOR STRENGTH IBUPROFEN, IBUPROFEN (OTC) LOPERAMIDE HYDROCHLORIDE, LOPERAMIDE HYDROCHLORIDE (OTC) MICONAZOLE NITRATE COMBINATION PACK, MICONAZOLE NITRATE (OTC) MINOXIDIL (FOR MEN), MINOXIDIL (OTC) MINOXIDIL (FOR WOMEN), MINOXIDIL (OTC) MOMETASONE FUROATE, MOMETASONE FUROATE NICOTINE POLACRILEX, NICOTINE POLACRILEX (OTC) PSEUDOEPHEDRINE HYDROCHLORIDE, PSEUDOEPHEDRINE HYDROCHLORIDE (OTC) STIE-CORT, HYDROCORTISONE PERRIGO CO TENNESSEE * PERRIGO CO TENNESSEE INC GRISEOFULVIN, GRISEOFULVIN, MICROCRYSTALLINE
SULFACETAMIDE SODIUM, SULFACETAMIDE SODIUM
PERRIGO ISRAEL * PERRIGO ISRAEL PHARMACEUTICALS LTD CETIRIZINE HYDROCHLORIDE, CETIRIZINE HYDROCHLORIDE CLOBETASOL PROPIONATE, CLOBETASOL PROPIONATE HALOBETASOL PROPIONATE, HALOBETASOL PROPIONATE
MESALAMINE, MESALAMINE
PERRIGO NEW YORK * PERRIGO NEW YORK INC AMMONIUM LACTATE, AMMONIUM LACTATE BETAMETHASONE DIPROPIONATE, BETAMETHASONE DIPROPIONATE CENTANY, MUPIROCIN CICLOPIROX, CICLOPIROX CLINDAMYCIN PHOSPHATE, CLINDAMYCIN PHOSPHATE DESONIDE, DESONIDE DESOXIMETASONE, DESOXIMETASONE ECONAZOLE NITRATE, ECONAZOLE NITRATE ERYTHROMYCIN, ERYTHROMYCIN FLUTICASONE PROPIONATE, FLUTICASONE PROPIONATE GENTAMICIN SULFATE, GENTAMICIN SULFATE HYDROCORTISONE VALERATE, HYDROCORTISONE VALERATE HYDROCORTISONE, HYDROCORTISONE KETOCONAZOLE, KETOCONAZOLE MINOXIDIL EXTRA STRENGTH (FOR MEN), MINOXIDIL (OTC) MOMETASONE FUROATE, MOMETASONE FUROATE MUPIROCIN, MUPIROCIN NYSTATIN, NYSTATIN PERMETHRIN, PERMETHRIN PERMETHRIN, PERMETHRIN (OTC) PROMETHAZINE HYDROCHLORIDE, PROMETHAZINE HYDROCHLORIDE
SELENIUM SULFIDE, SELENIUM SULFIDE

SEPTEMBER 2010 - APPROVED DRUG PRODUCTS LIST

B - 94

APPENDIX B
*

PRODUCT NAME SORTED BY APPLICANT


** P **

PERRIGO NEW YORK INC TERCONAZOLE, TERCONAZOLE


TRIAMCINOLONE ACETONIDE, TRIAMCINOLONE ACETONIDE

PERRIGO R AND D * PERRIGO R AND D CO CALCIUM CARBONATE, FAMOTIDINE AND MAGNESIUM HYDROXIDE, CALCIUM CARBONATE (OTC) CETIRIZINE HYDROCHLORIDE ALLERGY, CETIRIZINE HYDROCHLORIDE (OTC) CETIRIZINE HYDROCHLORIDE HIVES, CETIRIZINE HYDROCHLORIDE (OTC) CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY, CETIRIZINE HYDROCHLORIDE (OTC) CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF, CETIRIZINE HYDROCHLORIDE (OTC) GEMFIBROZIL, GEMFIBROZIL IBUPROFEN AND DIPHENHYDRAMINE CITRATE, DIPHENHYDRAMINE CITRATE (OTC) IBUPROFEN, IBUPROFEN IBUPROFEN, IBUPROFEN (OTC) MICONAZOLE NITRATE, MICONAZOLE NITRATE (OTC) NAPROXEN, NAPROXEN NICOTINE POLACRILEX, NICOTINE POLACRILEX (OTC) POLYETHYLENE GLYCOL 3350, POLYETHYLENE GLYCOL 3350 (OTC)
SIMVASTATIN, SIMVASTATIN
PERSONAL PRODS * PERSONAL PRODUCTS CO MONISTAT 3, MICONAZOLE NITRATE PFIZER * PFIZER CENTRAL RESEARCH DIFLUCAN, FLUCONAZOLE
ZITHROMAX, AZITHROMYCIN
* PFIZER CHEMICALS DIV PFIZER INC DIFLUCAN, FLUCONAZOLE
ZITHROMAX, AZITHROMYCIN
* PFIZER INC ANTIVERT, MECLIZINE HYDROCHLORIDE ARGATROBAN, ARGATROBAN CADUET, AMLODIPINE BESYLATE CARDURA XL, DOXAZOSIN MESYLATE CHILDREN'S ZYRTEC ALLERGY, CETIRIZINE HYDROCHLORIDE (OTC) CHILDREN'S ZYRTEC HIVES RELIEF, CETIRIZINE HYDROCHLORIDE (OTC) DIFLUCAN IN DEXTROSE 5% IN PLASTIC CONTAINER, FLUCONAZOLE DIFLUCAN IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, FLUCONAZOLE DIFLUCAN IN SODIUM CHLORIDE 0.9%, FLUCONAZOLE GEODON, ZIPRASIDONE HYDROCHLORIDE GEODON, ZIPRASIDONE MESYLATE GLUCOTROL XL, GLIPIZIDE GLUCOTROL, GLIPIZIDE LIPITOR, ATORVASTATIN CALCIUM LYRICA, PREGABALIN NAVANE, THIOTHIXENE NORVASC, AMLODIPINE BESYLATE PROCARDIA, NIFEDIPINE REVATIO, SILDENAFIL CITRATE RID MOUSSE, PIPERONYL BUTOXIDE (OTC) TOVIAZ, FESOTERODINE FUMARATE UNASYN, AMPICILLIN SODIUM VFEND, VORICONAZOLE
ZITHROMAX, AZITHROMYCIN
* PFIZER LABORATORIES DIV PFIZER INC CARDURA, DOXAZOSIN MESYLATE DIABINESE, CHLORPROPAMIDE FELDENE, PIROXICAM MINIPRESS, PRAZOSIN HYDROCHLORIDE PERMAPEN, PENICILLIN G BENZATHINE PFIZERPEN, PENICILLIN G POTASSIUM PROCARDIA XL, NIFEDIPINE STREPTOMYCIN SULFATE, STREPTOMYCIN SULFATE
TERRAMYCIN W/ POLYMYXIN B SULFATE, OXYTETRACYCLINE HYDROCHLORIDE

SEPTEMBER 2010 - APPROVED DRUG PRODUCTS LIST

B - 95

APPENDIX B

PRODUCT NAME SORTED BY APPLICANT


** P **

* PFIZER LABORATORIES DIV PFIZER INC UNASYN, AMPICILLIN SODIUM VIBRAMYCIN, DOXYCYCLINE VIBRAMYCIN, DOXYCYCLINE CALCIUM VIBRAMYCIN, DOXYCYCLINE HYCLATE VIBRA-TABS, DOXYCYCLINE HYCLATE
VISTARIL, HYDROXYZINE PAMOATE
* PFIZER PHARMACEUTICALS INC ZOLOFT, SERTRALINE HYDROCHLORIDE * PFIZER PHARMACEUTICALS PRODUCTION CORP LTD TIKOSYN, DOFETILIDE PFIZER GLOBAL * PFIZER GLOBAL RESEARCH DEVELOPMENT ZMAX, AZITHROMYCIN PFIZER INC * PFIZER INC CAMPTOSAR, IRINOTECAN HYDROCHLORIDE CHANTIX, VARENICLINE TARTRATE ELLENCE, EPIRUBICIN HYDROCHLORIDE GEODON, ZIPRASIDONE HYDROCHLORIDE
NICOTROL, NICOTINE
PFIZER IRELAND * PFIZER IRELAND PHARMACEUTICALS RELPAX, ELETRIPTAN HYDROBROMIDE
VIAGRA, SILDENAFIL CITRATE
PFIZER PHARMS * PFIZER PHARMACEUTICALS LTD ACCUPRIL, QUINAPRIL HYDROCHLORIDE ACCURETIC, HYDROCHLOROTHIAZIDE DILANTIN, PHENYTOIN LOPID, GEMFIBROZIL NEURONTIN, GABAPENTIN
NITROSTAT, NITROGLYCERIN
PHARM ASSOC * PHARMACEUTICAL ASSOC INC DOXEPIN HYDROCHLORIDE, DOXEPIN HYDROCHLORIDE HYDROCODONE BITARTRATE AND ACETAMINOPHEN, ACETAMINOPHEN NORTRIPTYLINE HYDROCHLORIDE, NORTRIPTYLINE HYDROCHLORIDE PERPHENAZINE, PERPHENAZINE
PREDNISOLONE SODIUM PHOSPHATE, PREDNISOLONE SODIUM PHOSPHATE
* PHARMACEUTICAL ASSOC INC DIV BEACH PRODUCTS ACETAMINOPHEN AND CODEINE PHOSPHATE, ACETAMINOPHEN AMANTADINE HYDROCHLORIDE, AMANTADINE HYDROCHLORIDE CIMETIDINE HYDROCHLORIDE, CIMETIDINE HYDROCHLORIDE DIPHENHYDRAMINE HYDROCHLORIDE, DIPHENHYDRAMINE HYDROCHLORIDE ETHOSUXIMIDE, ETHOSUXIMIDE FLUOXETINE HYDROCHLORIDE, FLUOXETINE HYDROCHLORIDE FLUPHENAZINE HYDROCHLORIDE, FLUPHENAZINE HYDROCHLORIDE HALOPERIDOL, HALOPERIDOL LACTATE HYDROCODONE BITARTRATE AND ACETAMINOPHEN, ACETAMINOPHEN LACTULOSE, LACTULOSE METOCLOPRAMIDE HYDROCHLORIDE, METOCLOPRAMIDE HYDROCHLORIDE OXYBUTYNIN CHLORIDE, OXYBUTYNIN CHLORIDE PREDNISOLONE, PREDNISOLONE PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE, CODEINE PHOSPHATE RANITIDINE HYDROCHLORIDE, RANITIDINE HYDROCHLORIDE TRIHEXYPHENIDYL HYDROCHLORIDE, TRIHEXYPHENIDYL HYDROCHLORIDE
VALPROIC ACID, VALPROIC ACID
PHARMA SERVE NY * PHARMA SERVE INC SUB TORIGIAN LABORATORIES AMINOPHYLLINE, AMINOPHYLLINE

SEPTEMBER 2010 - APPROVED DRUG PRODUCTS LIST

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APPENDIX B
PHARMACHEMIE * PHARMACHEMIE BV CARBOPLATIN, CARBOPLATIN CISPLATIN, CISPLATIN DOXORUBICIN HYDROCHLORIDE, ETOPOSIDE, ETOPOSIDE

PRODUCT NAME SORTED BY APPLICANT


** P **

DOXORUBICIN HYDROCHLORIDE

PHARMACHEMIE BV * PHARMACHEMIE BV BLEOMYCIN SULFATE, BLEOMYCIN SULFATE CARBOPLATIN, CARBOPLATIN


METHOTREXATE SODIUM PRESERVATIVE FREE,

METHOTREXATE SODIUM

PHARMACIA AND UPJOHN * PHARMACIA AND UPJOHN XANAX XR, ALPRAZOLAM * PHARMACIA AND UPJOHN CO ANSAID, FLURBIPROFEN AROMASIN, EXEMESTANE AZULFIDINE EN-TABS, SULFASALAZINE AZULFIDINE, SULFASALAZINE BACITRACIN, BACITRACIN CAVERJECT IMPULSE, ALPROSTADIL CAVERJECT, ALPROSTADIL CLEOCIN HYDROCHLORIDE, CLINDAMYCIN HYDROCHLORIDE CLEOCIN PHOSPHATE IN DEXTROSE 5% IN PLASTIC CONTAINER, CLEOCIN PHOSPHATE, CLINDAMYCIN PHOSPHATE CLEOCIN T, CLINDAMYCIN PHOSPHATE CLEOCIN, CLINDAMYCIN PALMITATE HYDROCHLORIDE CLEOCIN, CLINDAMYCIN PHOSPHATE COLESTID, COLESTIPOL HYDROCHLORIDE CORTEF, HYDROCORTISONE CORVERT, IBUTILIDE FUMARATE CYKLOKAPRON, TRANEXAMIC ACID DEPO-ESTRADIOL, ESTRADIOL CYPIONATE DEPO-MEDROL, METHYLPREDNISOLONE ACETATE DEPO-PROVERA, MEDROXYPROGESTERONE ACETATE DEPO-TESTOSTERONE, TESTOSTERONE CYPIONATE DETROL LA, TOLTERODINE TARTRATE DETROL, TOLTERODINE TARTRATE DIDREX, BENZPHETAMINE HYDROCHLORIDE EMCYT, ESTRAMUSTINE PHOSPHATE SODIUM ESTRING, ESTRADIOL FLAVORED COLESTID, COLESTIPOL HYDROCHLORIDE GENOTROPIN PRESERVATIVE FREE, SOMATROPIN RECOMBINANT GENOTROPIN, SOMATROPIN RECOMBINANT GLYNASE, GLYBURIDE GLYSET, MIGLITOL HALCION, TRIAZOLAM HEMABATE, CARBOPROST TROMETHAMINE IDAMYCIN PFS, IDARUBICIN HYDROCHLORIDE LINCOCIN, LINCOMYCIN HYDROCHLORIDE MEDROL, METHYLPREDNISOLONE MYCOBUTIN, RIFABUTIN NICOTROL, NICOTINE OGEN .625, ESTROPIPATE OGEN 1.25, ESTROPIPATE OGEN 2.5, ESTROPIPATE OGEN 5, ESTROPIPATE OGEN, ESTROPIPATE PREPIDIL, DINOPROSTONE PROSTIN E2, DINOPROSTONE PROSTIN VR PEDIATRIC, ALPROSTADIL PROVERA, MEDROXYPROGESTERONE ACETATE
R-GENE 10, ARGININE HYDROCHLORIDE

CLINDAMYCIN PHOSPHATE

SEPTEMBER 2010 - APPROVED DRUG PRODUCTS LIST

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APPENDIX B

PRODUCT NAME SORTED BY APPLICANT


** P **

* PHARMACIA AND UPJOHN CO SOLU-CORTEF, HYDROCORTISONE SODIUM SUCCINATE SOLU-MEDROL, METHYLPREDNISOLONE SODIUM SUCCINATE SOMAVERT, PEGVISOMANT TROBICIN, SPECTINOMYCIN HYDROCHLORIDE VANTIN, CEFPODOXIME PROXETIL XALATAN, LATANOPROST XANAX, ALPRAZOLAM ZINECARD, DEXRAZOXANE HYDROCHLORIDE
ZYVOX, LINEZOLID
* PHARMACIA AND UPJOHN SUB PFIZER INC DEPO-SUBQ PROVERA 104, MEDROXYPROGESTERONE ACETATE PHARMADERM * PHARMADERM DIV ALTANA INC BACITRACIN-NEOMYCIN-POLYMYXIN W/ HYDROCORTISONE ACETATE,

BACITRACIN

PHARMAFORCE * PHARMAFORCE INC BENZTROPINE MESYLATE, BENZTROPINE MESYLATE BUPRENORPHINE HYDROCHLORIDE, BUPRENORPHINE HYDROCHLORIDE CAFFEINE CITRATE, CAFFEINE CITRATE CIPROFLOXACIN HYDROCHLORIDE, CIPROFLOXACIN HYDROCHLORIDE CLONIDINE HYDROCHLORIDE, CLONIDINE HYDROCHLORIDE CYCLOSPORINE, CYCLOSPORINE DORZOLAMIDE HYDROCHLORIDE, DORZOLAMIDE HYDROCHLORIDE ESTRADIOL VALERATE, ESTRADIOL VALERATE ETOMIDATE, ETOMIDATE FENOLDOPAM MESYLATE, FENOLDOPAM MESYLATE FOMEPIZOLE, FOMEPIZOLE FOSPHENYTOIN SODIUM, FOSPHENYTOIN SODIUM IBUTILIDE FUMARATE, IBUTILIDE FUMARATE IRINOTECAN HYDROCHLORIDE, IRINOTECAN HYDROCHLORIDE METHYLERGONOVINE MALEATE, METHYLERGONOVINE MALEATE NEOMYCIN AND POLYMYXIN B SULFATES AND GRAMICIDIN, GRAMICIDIN NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE, HYDROCORTISONE NICARDIPINE HYDROCHLORIDE, NICARDIPINE HYDROCHLORIDE OFLOXACIN, OFLOXACIN ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE, ONDANSETRON HYDROCHLORIDE ONDANSETRON HYDROCHLORIDE, ONDANSETRON HYDROCHLORIDE PAMIDRONATE DISODIUM, PAMIDRONATE DISODIUM PHENYTOIN SODIUM, PHENYTOIN SODIUM PROGESTERONE, PROGESTERONE
PROMETHAZINE HYDROCHLORIDE, PROMETHAZINE HYDROCHLORIDE
PHARMALUCENCE * PHARMALUCENCE INC AN-DTPA, TECHNETIUM TC-99M PENTETATE KIT AN-SULFUR COLLOID, TECHNETIUM TC-99M SULFUR COLLOID KIT CIS-MDP, TECHNETIUM TC-99M MEDRONATE KIT CIS-PYRO, TECHNETIUM TC-99M PYROPHOSPHATE KIT HEPATOLITE, TECHNETIUM TC-99M DISOFENIN KIT PULMOLITE, TECHNETIUM TC-99M ALBUMIN AGGREGATED KIT TECHNETIUM TC 99M SESTAMIBI, TECHNETIUM TC-99M SESTAMIBI KIT
TECHNETIUM TC-99M MEBROFENIN, TECHNETIUM TC-99M MEBROFENIN KIT
PHARMASEAL * PHARMASEAL DIV BAXTER HEALTHCARE CORP PHARMASEAL SCRUB CARE, CHLORHEXIDINE GLUCONATE PHARMAX * PHARMAX GROUP INC BETHANECHOL CHLORIDE, BETHANECHOL CHLORIDE
FOLIC ACID, FOLIC ACID
PIERRE FABRE * PIERRE FABRE MEDICAMENT NAVELBINE, VINORELBINE TARTRATE

(OTC)

SEPTEMBER 2010 - APPROVED DRUG PRODUCTS LIST

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APPENDIX B

PRODUCT NAME SORTED BY APPLICANT


** P **

PIERREL * PIERREL S.P.A. ARTICAINE HYDROCHLORIDE WITH EPINEPHRINE, PIRAMAL CRITICAL * PIRAMAL CRITICAL CARE INC ENFLURANE, ENFLURANE ISOFLURANE, ISOFLURANE
SOJOURN, SEVOFLURANE

ARTICAINE HYDROCHLORIDE

PLANTEX * PLANTEX USA INC DIV IKAPHARM INC SULFAMETHOXAZOLE AND TRIMETHOPRIM SINGLE STRENGTH,

SULFAMETHOXAZOLE

PLIVA * PLIVA INC AZITHROMYCIN, AZITHROMYCIN BENZTROPINE MESYLATE, BENZTROPINE MESYLATE CARBOPLATIN, CARBOPLATIN CHLORPROPAMIDE, CHLORPROPAMIDE CHLORTHALIDONE, CHLORTHALIDONE CIMETIDINE, CIMETIDINE CIPROFLOXACIN HYDROCHLORIDE, CIPROFLOXACIN HYDROCHLORIDE CITALOPRAM HYDROBROMIDE, CITALOPRAM HYDROBROMIDE CYCLOBENZAPRINE HYDROCHLORIDE, CYCLOBENZAPRINE HYDROCHLORIDE CYCLOSPORINE, CYCLOSPORINE CYPROHEPTADINE HYDROCHLORIDE, CYPROHEPTADINE HYDROCHLORIDE DOXAZOSIN MESYLATE, DOXAZOSIN MESYLATE FLUCONAZOLE, FLUCONAZOLE FLUOXETINE HYDROCHLORIDE, FLUOXETINE HYDROCHLORIDE HYDRALAZINE HYDROCHLORIDE, HYDRALAZINE HYDROCHLORIDE HYDROXYZINE HYDROCHLORIDE, HYDROXYZINE HYDROCHLORIDE KETOCONAZOLE, KETOCONAZOLE KETOROLAC TROMETHAMINE, KETOROLAC TROMETHAMINE METRONIDAZOLE, METRONIDAZOLE NAPROXEN, NAPROXEN OXYBUTYNIN CHLORIDE, OXYBUTYNIN CHLORIDE PENTOXIFYLLINE, PENTOXIFYLLINE PROPAFENONE HYDROCHLORIDE, PROPAFENONE HYDROCHLORIDE PROPRANOLOL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE PROPRANOLOL HYDROCHLORIDE, PROPRANOLOL HYDROCHLORIDE THEOPHYLLINE, THEOPHYLLINE TRAMADOL HYDROCHLORIDE, TRAMADOL HYDROCHLORIDE TRAZODONE HYDROCHLORIDE, TRAZODONE HYDROCHLORIDE TRIAMTERENE AND HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE
WARFARIN SODIUM, WARFARIN SODIUM
PLIVA HRVATSKA DOO * PLIVA HRVATSKA DOO AZITHROMYCIN, AZITHROMYCIN CARVEDILOL, CARVEDILOL CILOSTAZOL, CILOSTAZOL ONDANSETRON HYDROCHLORIDE, ONDANSETRON HYDROCHLORIDE PRAVASTATIN SODIUM, PRAVASTATIN SODIUM RISPERIDONE, RISPERIDONE SERTRALINE HYDROCHLORIDE, SERTRALINE HYDROCHLORIDE
VENLAFAXINE HYDROCHLORIDE, VENLAFAXINE HYDROCHLORIDE
PLIVA LACHEMA * PLIVA LACHEMA AS CARBOPLATIN, CARBOPLATIN IRINOTECAN HYDROCHLORIDE, IRINOTECAN HYDROCHLORIDE PACLITAXEL, PACLITAXEL
PAMIDRONATE DISODIUM, PAMIDRONATE DISODIUM
PLIVA PHARM IND * PLIVA PHARMACEUTICAL INDUSTRY INC TORSEMIDE, TORSEMIDE

SEPTEMBER 2010 - APPROVED DRUG PRODUCTS LIST

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APPENDIX B
POHL BOSKAMP * POHL BOSKAMP NITROLINGUAL PUMPSPRAY,

PRODUCT NAME SORTED BY APPLICANT


** P **

NITROGLYCERIN

POLYMEDICA * POLYMEDICA INDUSTRIES INC ANESTACON, LIDOCAINE HYDROCHLORIDE


NEOPAP, ACETAMINOPHEN (OTC)
PRASCO * PRASCO LLC DBA PRASCO LABORATORIES ECONAZOLE NITRATE, ECONAZOLE NITRATE PRIMAPHARM * PRIMAPHARM INC HYDASE, HYALURONIDASE PRISM PHARMS * PRISM PHARMACEUTICALS INC NEXTERONE, AMIODARONE HYDROCHLORIDE PROCTER AND GAMBLE * PROCTER AND GAMBLE PHARMACEUTICALS INC SUB PROCTER AND GAMBLE CO DIDRONEL, ETIDRONATE DISODIUM
MACROBID, NITROFURANTOIN
PROGENICS * PROGENICS PHARMACEUTICALS INC RELISTOR, METHYLNALTREXONE BROMIDE PROMETHEUS LABS * PROMETHEUS LABORATORIES INC HELIDAC, BISMUTH SUBSALICYLATE IMURAN, AZATHIOPRINE LOTRONEX, ALOSETRON HYDROCHLORIDE MERCAPTOPURINE, MERCAPTOPURINE RIDAURA, AURANOFIN TRANDATE, LABETALOL HYDROCHLORIDE
ZYLOPRIM, ALLOPURINOL
PROMIUS PHARMA * PROMIUS PHARMA LLC ISMO, ISOSORBIDE MONONITRATE SECTRAL, ACEBUTOLOL HYDROCHLORIDE
TENEX, GUANFACINE HYDROCHLORIDE
PROVIDENT PHARM * PROVIDENT PHARMACEUTICAL INC METFORMIN HYDROCHLORIDE, METFORMIN HYDROCHLORIDE PULSION MEDCL * PULSION MEDICAL SYSTEMS AG INDOCYANINE GREEN, INDOCYANINE GREEN PURDUE GMP * PURDUE GMP CENTER LLC DBA THE CHAO CENTER INDUSTRIAL PHARMACY SEROMYCIN, CYCLOSERINE PURDUE PHARM PRODS * PURDUE PHARMACEUTICAL PRODUCTS LP DILAUDID, HYDROMORPHONE HYDROCHLORIDE DILAUDID-HP, HYDROMORPHONE HYDROCHLORIDE
UNIPHYL, THEOPHYLLINE
PURDUE PHARMA * PURDUE PHARMA PRODUCTS LP RYZOLT, TRAMADOL HYDROCHLORIDE PURDUE PHARMA LP * PURDUE PHARMA LP MS CONTIN, MORPHINE SULFATE
OXYCONTIN, OXYCODONE HYDROCHLORIDE

SEPTEMBER 2010 - APPROVED DRUG PRODUCTS LIST

B - 100

APPENDIX B

PRODUCT NAME SORTED BY APPLICANT


** P **

PUREPAC PHARM * PUREPAC PHARMACEUTICAL CO DIPYRIDAMOLE, DIPYRIDAMOLE QLT * QLT INC VISUDYNE,

VERTEPORFIN

QOL MEDCL * QOL MEDICAL LLC ELLIOTTS B SOLUTION, CALCIUM CHLORIDE ETHAMOLIN, ETHANOLAMINE OLEATE
SUCRAID, SACROSIDASE
QPHARMA * QPHARMA LLC CROMOLYN SODIUM, CROMOLYN SODIUM FLUNISOLIDE, FLUNISOLIDE
QUESTCOR PHARMS * QUESTCOR PHARMACEUTICALS INC DORAL, QUAZEPAM H.P. ACTHAR GEL, CORTICOTROPIN RANBAXY * RANBAXY INC ACETAMINOPHEN, ACETAMINOPHEN (OTC) GLYCOPYRROLATE, GLYCOPYRROLATE
HYDROCODONE BITARTRATE AND ACETAMINOPHEN, ACETAMINOPHEN
* RANBAXY LABORATORIES INC EURAX, CROTAMITON EXELDERM, SULCONAZOLE NITRATE FAMOTIDINE, FAMOTIDINE (OTC) HALOG, HALCINONIDE HYDROCODONE BITARTRATE AND ACETAMINOPHEN, ACETAMINOPHEN ISOPTIN SR, VERAPAMIL HYDROCHLORIDE KENALOG, TRIAMCINOLONE ACETONIDE LAC-HYDRIN, AMMONIUM LACTATE ULTRAVATE, HALOBETASOL PROPIONATE
WESTCORT, HYDROCORTISONE VALERATE
* RANBAXY LABORATORIES LTD ACYCLOVIR, ACYCLOVIR AMLODIPINE BESYLATE, AMLODIPINE BESYLATE AMOXICILLIN AND CLAVULANATE POTASSIUM, AMOXICILLIN AMOXICILLIN, AMOXICILLIN BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE, BENAZEPRIL HYDROCHLORIDE BENAZEPRIL HYDROCHLORIDE, BENAZEPRIL HYDROCHLORIDE CARVEDILOL, CARVEDILOL CEFADROXIL, CEFADROXIL/CEFADROXIL HEMIHYDRATE CEFPODOXIME PROXETIL, CEFPODOXIME PROXETIL CEFPROZIL, CEFPROZIL CEFUROXIME AXETIL, CEFUROXIME AXETIL CEPHALEXIN, CEPHALEXIN CETIRIZINE HYDROCHLORIDE ALLERGY, CETIRIZINE HYDROCHLORIDE (OTC) CETIRIZINE HYDROCHLORIDE HIVES, CETIRIZINE HYDROCHLORIDE (OTC) CETIRIZINE HYDROCHLORIDE, CETIRIZINE HYDROCHLORIDE CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY, CETIRIZINE HYDROCHLORIDE (OTC) CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF, CETIRIZINE HYDROCHLORIDE (OTC) CLARITHROMYCIN, CLARITHROMYCIN CLINDAMYCIN HYDROCHLORIDE, CLINDAMYCIN HYDROCHLORIDE CLORAZEPATE DIPOTASSIUM, CLORAZEPATE DIPOTASSIUM CYCLOBENZAPRINE HYDROCHLORIDE, CYCLOBENZAPRINE HYDROCHLORIDE DISPERMOX, AMOXICILLIN DOXYCYCLINE, DOXYCYCLINE ENALAPRIL MALEATE, ENALAPRIL MALEATE FENOFIBRATE, FENOFIBRATE
FLECAINIDE ACETATE, FLECAINIDE ACETATE

(OTC)

SEPTEMBER 2010 - APPROVED DRUG PRODUCTS LIST

B - 101

APPENDIX B

PRODUCT NAME SORTED BY APPLICANT


** R **

* RANBAXY LABORATORIES LTD FLUCONAZOLE, FLUCONAZOLE FLUOXETINE HYDROCHLORIDE, FLUOXETINE HYDROCHLORIDE FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE, FOSINOPRIL SODIUM FOSINOPRIL SODIUM, FOSINOPRIL SODIUM GABAPENTIN, GABAPENTIN GANCICLOVIR, GANCICLOVIR GLIMEPIRIDE, GLIMEPIRIDE HYDROCODONE BITARTRATE AND ACETAMINOPHEN, ACETAMINOPHEN LORATADINE AND PSEUDOEPHEDRINE SULFATE, LORATADINE (OTC) LORATADINE REDIDOSE, LORATADINE (OTC) LORATADINE, LORATADINE (OTC) LORAZEPAM, LORAZEPAM METFORMIN HYDROCHLORIDE, METFORMIN HYDROCHLORIDE MIDAZOLAM HYDROCHLORIDE, MIDAZOLAM HYDROCHLORIDE MINOCYCLINE HYDROCHLORIDE, MINOCYCLINE HYDROCHLORIDE NEFAZODONE HYDROCHLORIDE, NEFAZODONE HYDROCHLORIDE NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS), NITROFURANTOIN OFLOXACIN, OFLOXACIN OXCARBAZEPINE, OXCARBAZEPINE PANIXINE DISPERDOSE, CEPHALEXIN PRAVASTATIN SODIUM, PRAVASTATIN SODIUM PSEUDOEPHEDRINE HYDROCHLORIDE, PSEUDOEPHEDRINE HYDROCHLORIDE (OTC) QUINAPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE QUINAPRIL HYDROCHLORIDE, QUINAPRIL HYDROCHLORIDE RAMIPRIL, RAMIPRIL RANICLOR, CEFACLOR RANITIDINE HYDROCHLORIDE, RANITIDINE HYDROCHLORIDE SERTRALINE HYDROCHLORIDE, SERTRALINE HYDROCHLORIDE SIMVASTATIN, SIMVASTATIN SOTRET, ISOTRETINOIN SUMATRIPTAN SUCCINATE, SUMATRIPTAN SUCCINATE TERAZOSIN HYDROCHLORIDE, TERAZOSIN HYDROCHLORIDE TOPIRAMATE, TOPIRAMATE VALACYCLOVIR HYDROCHLORIDE, VALACYCLOVIR HYDROCHLORIDE ZIDOVUDINE, ZIDOVUDINE
ZOLPIDEM TARTRATE, ZOLPIDEM TARTRATE
* RANBAXY PHARMACEUTICALS INC ACETAMINOPHEN AND CODEINE PHOSPHATE, ACETAMINOPHEN AMOXICILLIN AND CLAVULANATE POTASSIUM, AMOXICILLIN AMOXICILLIN, AMOXICILLIN AVENTYL HYDROCHLORIDE, NORTRIPTYLINE HYDROCHLORIDE CEFACLOR, CEFACLOR CEFADROXIL, CEFADROXIL/CEFADROXIL HEMIHYDRATE CIPROFLOXACIN HYDROCHLORIDE, CIPROFLOXACIN HYDROCHLORIDE LISINOPRIL AND HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE LISINOPRIL, LISINOPRIL LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE, LOPERAMIDE HYDROCHLORIDE (OTC) PENTAZOCINE AND NALOXONE HYDROCHLORIDES, NALOXONE HYDROCHLORIDE RIOMET, METFORMIN HYDROCHLORIDE SECONAL SODIUM, SECOBARBITAL SODIUM
SOTRET, ISOTRETINOIN
RARE DIS * RARE DISEASE THERAPEUTICS INC ORFADIN, NITISINONE RARE DIS THERAP * RARE DISEASE THERAPEUTICS INC CYSTADANE, BETAINE HYDROCHLORIDE RECIP * RECIP AB THYROSAFE,

POTASSIUM IODIDE

(OTC)

SEPTEMBER 2010 - APPROVED DRUG PRODUCTS LIST

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APPENDIX B

PRODUCT NAME SORTED BY APPLICANT

** R **

RECKITT BENCKISER * RECKITT BENCKISER DELSYM, DEXTROMETHORPHAN POLISTIREX (OTC) * RECKITT BENCKISER INC MUCINEX D, GUAIFENESIN (OTC) MUCINEX DM, DEXTROMETHORPHAN HYDROBROMIDE (OTC) MUCINEX, GUAIFENESIN (OTC) * RECKITT BENCKISER PHARMACEUTICALS INC BUPRENEX, BUPRENORPHINE HYDROCHLORIDE SUBOXONE, BUPRENORPHINE HYDROCHLORIDE
SUBUTEX, BUPRENORPHINE HYDROCHLORIDE
REGENT * REGENT MEDICAL AMERICAS LLC HIBICLENS, CHLORHEXIDINE GLUCONATE (OTC)
HIBISTAT, CHLORHEXIDINE GLUCONATE (OTC)
RESPIRARE * RESPIRARE LLC CROMOLYN SODIUM, RHODIA * RHODIA LTD ISOFLURANE,

CROMOLYN SODIUM

ISOFLURANE

ROCHE * HOFFMANN LA ROCHE INC BONIVA, IBANDRONATE SODIUM COPEGUS, RIBAVIRIN FUZEON, ENFUVIRTIDE INVIRASE, SAQUINAVIR MESYLATE KLONOPIN, CLONAZEPAM KYTRIL, GRANISETRON HYDROCHLORIDE TAMIFLU, OSELTAMIVIR PHOSPHATE
VALIUM, DIAZEPAM
ROCHE PALO * ROCHE PALO ALTO LLC AEROBID, FLUNISOLIDE ANAPROX DS, NAPROXEN SODIUM ANAPROX, NAPROXEN SODIUM CELLCEPT, MYCOPHENOLATE MOFETIL CELLCEPT, MYCOPHENOLATE MOFETIL HYDROCHLORIDE CYTOVENE, GANCICLOVIR SODIUM EC-NAPROSYN, NAPROXEN NAPROSYN, NAPROXEN
VALCYTE, VALGANCICLOVIR HYDROCHLORIDE
ROMARK * ROMARK LABORATORIES ALINIA, NITAZOXANIDE ROSEDALE THERAPEUTIC * ROSEDALE THERAPEUTICS ERGOMAR, ERGOTAMINE TARTRATE ROSS LABS * ROSS LABORATORIES DIV ABBOTT LABORATORIES INC PEDIAMYCIN 400, ERYTHROMYCIN ETHYLSUCCINATE PEDIAMYCIN, ERYTHROMYCIN ETHYLSUCCINATE
SURVANTA, BERACTANT
ROXANE * ROXANE LABORATORIES INC ACARBOSE, ACARBOSE ALPRAZOLAM, ALPRAZOLAM AMLODIPINE BESYLATE, AMLODIPINE BESYLATE AZATHIOPRINE, AZATHIOPRINE BALSALAZIDE DISODIUM, BALSALAZIDE DISODIUM BUPRENORPHINE HYDROCHLORIDE, BUPRENORPHINE HYDROCHLORIDE

SEPTEMBER 2010 - APPROVED DRUG PRODUCTS LIST

B - 103

APPENDIX B

PRODUCT NAME SORTED BY APPLICANT


** R **

* ROXANE LABORATORIES INC BUTORPHANOL TARTRATE, BUTORPHANOL TARTRATE CALCITRIOL, CALCITRIOL CALCIUM ACETATE, CALCIUM ACETATE CILOSTAZOL, CILOSTAZOL CITALOPRAM HYDROBROMIDE, CITALOPRAM HYDROBROMIDE CLARITHROMYCIN, CLARITHROMYCIN CLOTRIMAZOLE, CLOTRIMAZOLE CODEINE SULFATE, CODEINE SULFATE CYCLOPHOSPHAMIDE, CYCLOPHOSPHAMIDE DEXAMETHASONE INTENSOL, DEXAMETHASONE DEXAMETHASONE, DEXAMETHASONE DIAZEPAM INTENSOL, DIAZEPAM DIAZEPAM, DIAZEPAM DIGOXIN, DIGOXIN DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE, ATROPINE SULFATE DOLOPHINE HYDROCHLORIDE, METHADONE HYDROCHLORIDE FLECAINIDE ACETATE, FLECAINIDE ACETATE FLUCONAZOLE, FLUCONAZOLE FLUTICASONE PROPIONATE, FLUTICASONE PROPIONATE FUROSEMIDE, FUROSEMIDE GALANTAMINE HYDROBROMIDE, GALANTAMINE HYDROBROMIDE GRANISETRON HYDROCHLORIDE, GRANISETRON HYDROCHLORIDE HYDROMORPHONE HYDROCHLORIDE, HYDROMORPHONE HYDROCHLORIDE IPRATROPIUM BROMIDE, IPRATROPIUM BROMIDE LACTULOSE, LACTULOSE LAMOTRIGINE, LAMOTRIGINE LEUCOVORIN CALCIUM, LEUCOVORIN CALCIUM LEVETIRACETAM, LEVETIRACETAM LEVORPHANOL TARTRATE, LEVORPHANOL TARTRATE LIDOCAINE HYDROCHLORIDE, LIDOCAINE HYDROCHLORIDE LIDOCAINE VISCOUS, LIDOCAINE HYDROCHLORIDE LITHIUM CARBONATE, LITHIUM CARBONATE LITHIUM CITRATE, LITHIUM CITRATE LOPERAMIDE HYDROCHLORIDE, LOPERAMIDE HYDROCHLORIDE (OTC) LORAZEPAM INTENSOL, LORAZEPAM LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE MEFLOQUINE HYDROCHLORIDE, MEFLOQUINE HYDROCHLORIDE MEGESTROL ACETATE, MEGESTROL ACETATE MEPERIDINE HYDROCHLORIDE, MEPERIDINE HYDROCHLORIDE MERCAPTOPURINE, MERCAPTOPURINE METHADONE HYDROCHLORIDE INTENSOL, METHADONE HYDROCHLORIDE METHADONE HYDROCHLORIDE, METHADONE HYDROCHLORIDE METHOTREXATE SODIUM, METHOTREXATE SODIUM MIDAZOLAM HYDROCHLORIDE, MIDAZOLAM HYDROCHLORIDE MORPHINE SULFATE, MORPHINE SULFATE MYCOPHENOLATE MOFETIL, MYCOPHENOLATE MOFETIL NAPROXEN, NAPROXEN ONDANSETRON HYDROCHLORIDE, ONDANSETRON HYDROCHLORIDE OXCARBAZEPINE, OXCARBAZEPINE PERINDOPRIL ERBUMINE, PERINDOPRIL ERBUMINE PILOCARPINE HYDROCHLORIDE, PILOCARPINE HYDROCHLORIDE PREDNISONE INTENSOL, PREDNISONE PREDNISONE, PREDNISONE PROPRANOLOL HYDROCHLORIDE, PROPRANOLOL HYDROCHLORIDE PROTRIPTYLINE HYDROCHLORIDE, PROTRIPTYLINE HYDROCHLORIDE RAMIPRIL, RAMIPRIL RISPERIDONE, RISPERIDONE ROPINIROLE HYDROCHLORIDE, ROPINIROLE HYDROCHLORIDE ROXICET 5/500, ACETAMINOPHEN ROXICET, ACETAMINOPHEN ROXILOX, ACETAMINOPHEN SERTRALINE HYDROCHLORIDE, SERTRALINE HYDROCHLORIDE SODIUM POLYSTYRENE SULFONATE, SODIUM POLYSTYRENE SULFONATE
SUMATRIPTAN SUCCINATE, SUMATRIPTAN SUCCINATE

SEPTEMBER 2010 - APPROVED DRUG PRODUCTS LIST

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APPENDIX B

PRODUCT NAME SORTED BY APPLICANT


** R **

* ROXANE LABORATORIES INC TERBINAFINE HYDROCHLORIDE, TERBINAFINE HYDROCHLORIDE TOPIRAMATE, TOPIRAMATE TORSEMIDE, TORSEMIDE TRIAZOLAM, TRIAZOLAM ZALEPLON, ZALEPLON ZIDOVUDINE, ZIDOVUDINE
ZOLPIDEM TARTRATE, ZOLPIDEM TARTRATE
SAGE PRODS * SAGE PRODUCTS INC CHLORHEXIDINE GLUCONATE,

CHLORHEXIDINE GLUCONATE

(OTC)

SAGENT STRIDES * SAGENT STRIDES LLC AZITHROMYCIN, AZITHROMYCIN GRANISETRON HYDROCHLORIDE, GRANISETRON HYDROCHLORIDE LABETALOL HYDROCLORIDE, LABETALOL HYDROCHLORIDE
MESNA, MESNA
SALIX PHARMS * SALIX PHARMACEUTICALS INC ANUSOL HC, HYDROCORTISONE APRISO, MESALAMINE COLAZAL, BALSALAZIDE DISODIUM DIURIL, CHLOROTHIAZIDE METOZOLV ODT, METOCLOPRAMIDE HYDROCHLORIDE MOVIPREP, ASCORBIC ACID OSMOPREP, SODIUM PHOSPHATE, DIBASIC ANHYDROUS PEPCID, FAMOTIDINE VISICOL, SODIUM PHOSPHATE, DIBASIC ANHYDROUS
XIFAXAN, RIFAXIMIN
SAMSON MEDCL * SAMSON MEDICAL TECHNOLOGIES LLC CEFAZOLIN SODIUM, CEFAZOLIN SODIUM
CEFUROXIME SODIUM IN PLASTIC CONTAINER,

CEFUROXIME SODIUM

SANDOZ * SANDOZ CANADA INC ANECTINE, SUCCINYLCHOLINE CHLORIDE ARISTOSPAN, TRIAMCINOLONE HEXACETONIDE BRIMONIDINE TARTRATE, BRIMONIDINE TARTRATE COSYNTROPIN, COSYNTROPIN DIGOXIN, DIGOXIN DORZOLAMIDE HYDROCHLORIDE, DORZOLAMIDE HYDROCHLORIDE ESTRADIOL VALERATE, ESTRADIOL VALERATE FENOLDOPAM MESYLATE, FENOLDOPAM MESYLATE FLUMAZENIL, FLUMAZENIL GRANISETRON HYDROCHLORIDE, GRANISETRON HYDROCHLORIDE INFUVITE ADULT, ALPHA-TOCOPHEROL ACETATE INFUVITE PEDIATRIC (PHARMACY BULK PACKAGE), ASCORBIC ACID INFUVITE PEDIATRIC, ASCORBIC ACID ISONIAZID, ISONIAZID KETOROLAC TROMETHAMINE, KETOROLAC TROMETHAMINE MEDROXYPROGESTERONE ACETATE, MEDROXYPROGESTERONE ACETATE METHYLPREDNISOLONE ACETATE, METHYLPREDNISOLONE ACETATE METOPROLOL TARTRATE, METOPROLOL TARTRATE ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE, ONDANSETRON HYDROCHLORIDE ONDANSETRON HYDROCHLORIDE, ONDANSETRON HYDROCHLORIDE PROPRANOLOL HYDROCHLORIDE, PROPRANOLOL HYDROCHLORIDE REGONOL, PYRIDOSTIGMINE BROMIDE ROCURONIUM BROMIDE, ROCURONIUM BROMIDE SUMATRIPTAN SUCCINATE, SUMATRIPTAN SUCCINATE TESTOSTERONE CYPIONATE, TESTOSTERONE CYPIONATE
TRIAMCINOLONE ACETONIDE, TRIAMCINOLONE ACETONIDE
* SANDOZ INC ALBUTEROL SULFATE AND IPRATROPIUM BROMIDE, ALBUTEROL SULFATE

SEPTEMBER 2010 - APPROVED DRUG PRODUCTS LIST

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APPENDIX B

PRODUCT NAME SORTED BY APPLICANT


** S **

* SANDOZ INC ALENDRONATE SODIUM, ALENDRONATE SODIUM ALPRAZOLAM, ALPRAZOLAM AMANTADINE HYDROCHLORIDE, AMANTADINE HYDROCHLORIDE AMIODARONE HYDROCHLORIDE, AMIODARONE HYDROCHLORIDE AMITRIPTYLINE HYDROCHLORIDE, AMITRIPTYLINE HYDROCHLORIDE AMOXICILLIN AND CLAVULANATE POTASSIUM, AMOXICILLIN AMOXICILLIN, AMOXICILLIN AMPICILLIN AND SULBACTAM, AMPICILLIN SODIUM AMPICILLIN SODIUM, AMPICILLIN SODIUM AMPICILLIN TRIHYDRATE, AMPICILLIN/AMPICILLIN TRIHYDRATE ANAGRELIDE HYDROCHLORIDE, ANAGRELIDE HYDROCHLORIDE ATENOLOL, ATENOLOL AZITHROMYCIN, AZITHROMYCIN BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE, BENAZEPRIL HYDROCHLORIDE BENAZEPRIL HYDROCHLORIDE, BENAZEPRIL HYDROCHLORIDE BICALUTAMIDE, BICALUTAMIDE BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE, BISOPROLOL FUMARATE BISOPROLOL FUMARATE, BISOPROLOL FUMARATE BUMETANIDE, BUMETANIDE BUPROPION HYDROCHLORIDE, BUPROPION HYDROCHLORIDE CAFERGOT, CAFFEINE CAPTOPRIL, CAPTOPRIL CARBOPLATIN, CARBOPLATIN CARISOPRODOL AND ASPIRIN, ASPIRIN CARISOPRODOL, ASPIRIN AND CODEINE PHOSPHATE, ASPIRIN CARVEDILOL, CARVEDILOL CEFADROXIL, CEFADROXIL/CEFADROXIL HEMIHYDRATE CEFAZOLIN SODIUM, CEFAZOLIN SODIUM CEFDINIR, CEFDINIR CEFPODOXIME PROXETIL, CEFPODOXIME PROXETIL CEFPROZIL, CEFPROZIL CEFTRIAXONE, CEFTRIAXONE SODIUM CEFUROXIME AXETIL, CEFUROXIME AXETIL CETIRIZINE HYDROCHLORIDE ALLERGY, CETIRIZINE HYDROCHLORIDE (OTC) CETIRIZINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE, CETIRIZINE HYDROCHLORIDE (OTC) CHLORPROMAZINE HYDROCHLORIDE, CHLORPROMAZINE HYDROCHLORIDE CHOLESTYRAMINE LIGHT, CHOLESTYRAMINE CHOLESTYRAMINE, CHOLESTYRAMINE CILOSTAZOL, CILOSTAZOL CIMETIDINE, CIMETIDINE CITALOPRAM HYDROBROMIDE, CITALOPRAM HYDROBROMIDE CLARITHROMYCIN, CLARITHROMYCIN CLEMASTINE FUMARATE, CLEMASTINE FUMARATE CLEMASTINE FUMARATE, CLEMASTINE FUMARATE (OTC) CLOMIPRAMINE HYDROCHLORIDE, CLOMIPRAMINE HYDROCHLORIDE CLONAZEPAM, CLONAZEPAM CYCLOBENZAPRINE HYDROCHLORIDE, CYCLOBENZAPRINE HYDROCHLORIDE CYCLOSPORINE, CYCLOSPORINE DESIPRAMINE HYDROCHLORIDE, DESIPRAMINE HYDROCHLORIDE DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE, AMPHETAMINE ASPARTATE
DICLOFENAC POTASSIUM, DICLOFENAC POTASSIUM
DICLOFENAC SODIUM, DICLOFENAC SODIUM
DICLOXACILLIN SODIUM, DICLOXACILLIN SODIUM
DIVALPROEX SODIUM, DIVALPROEX SODIUM
DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE, DORZOLAMIDE HYDROCHLORIDE
DOXAZOSIN MESYLATE, DOXAZOSIN MESYLATE
DOXYCYCLINE HYCLATE, DOXYCYCLINE HYCLATE
DOXYCYCLINE, DOXYCYCLINE
ENALAPRIL MALEATE AND HYDROCHLOROTHIAZIDE, ENALAPRIL MALEATE
ENALAPRIL MALEATE, ENALAPRIL MALEATE
EPLERENONE, EPLERENONE
ETODOLAC, ETODOLAC

SEPTEMBER 2010 - APPROVED DRUG PRODUCTS LIST

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APPENDIX B

PRODUCT NAME SORTED BY APPLICANT


** S **

* SANDOZ INC FAMOTIDINE, FAMOTIDINE FAMOTIDINE, FAMOTIDINE (OTC) FLUOXETINE HYDROCHLORIDE, FLUOXETINE HYDROCHLORIDE FLUPHENAZINE HYDROCHLORIDE, FLUPHENAZINE HYDROCHLORIDE FLUTAMIDE, FLUTAMIDE FLUVOXAMINE MALEATE, FLUVOXAMINE MALEATE FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE, FOSINOPRIL SODIUM FOSINOPRIL SODIUM, FOSINOPRIL SODIUM FUROSEMIDE, FUROSEMIDE GABAPENTIN, GABAPENTIN GALANTAMINE HYDROBROMIDE, GALANTAMINE HYDROBROMIDE GLIPIZIDE, GLIPIZIDE HALOPERIDOL, HALOPERIDOL HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE HYDROCODONE BITARTRATE AND ACETAMINOPHEN, ACETAMINOPHEN HYDROXYCHLOROQUINE SULFATE, HYDROXYCHLOROQUINE SULFATE HYDROXYZINE PAMOATE, HYDROXYZINE PAMOATE IBUPROFEN, IBUPROFEN (OTC) IMIPRAMINE HYDROCHLORIDE, IMIPRAMINE HYDROCHLORIDE INDAPAMIDE, INDAPAMIDE INDOCIN SR, INDOMETHACIN INDOMETHACIN, INDOMETHACIN INVAGESIC FORTE, ASPIRIN INVAGESIC, ASPIRIN ISONIAZID, ISONIAZID ISOSORBIDE DINITRATE, ISOSORBIDE DINITRATE ITRACONAZOLE, ITRACONAZOLE LABETALOL HYDROCHLORIDE, LABETALOL HYDROCHLORIDE LAMOTRIGINE, LAMOTRIGINE LEFLUNOMIDE, LEFLUNOMIDE LEUCOVORIN CALCIUM, LEUCOVORIN CALCIUM LEVETIRACETAM, LEVETIRACETAM LISINOPRIL AND HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE LISINOPRIL, LISINOPRIL LOCHOLEST LIGHT, CHOLESTYRAMINE LOCHOLEST, CHOLESTYRAMINE LONOX, ATROPINE SULFATE LORATADINE, LORATADINE (OTC) LORAZEPAM, LORAZEPAM LOVASTATIN, LOVASTATIN MECLIZINE HYDROCHLORIDE, MECLIZINE HYDROCHLORIDE MEFLOQUINE HYDROCHLORIDE, MEFLOQUINE HYDROCHLORIDE METAXALONE, METAXALONE METFORMIN HYDROCHLORIDE, METFORMIN HYDROCHLORIDE METHADONE HYDROCHLORIDE, METHADONE HYDROCHLORIDE METHAZOLAMIDE, METHAZOLAMIDE METHIMAZOLE, METHIMAZOLE METHOCARBAMOL, METHOCARBAMOL METHYLPREDNISOLONE, METHYLPREDNISOLONE METOLAZONE, METOLAZONE METOPROLOL SUCCINATE, METOPROLOL SUCCINATE METOPROLOL TARTRATE, METOPROLOL TARTRATE METRONIDAZOLE, METRONIDAZOLE MIDODRINE HYDROCHLORIDE, MIDODRINE HYDROCHLORIDE MINOCYCLINE HYDROCHLORIDE, MINOCYCLINE HYDROCHLORIDE MIRTAZAPINE, MIRTAZAPINE MYCOPHENOLATE MOFETIL, MYCOPHENOLATE MOFETIL NABUMETONE, NABUMETONE NADOLOL, NADOLOL NAFCILLIN SODIUM, NAFCILLIN SODIUM NALTREXONE HYDROCHLORIDE, NALTREXONE HYDROCHLORIDE NAPROXEN SODIUM, NAPROXEN SODIUM NAPROXEN SODIUM, NAPROXEN SODIUM (OTC)
NAPROXEN, NAPROXEN

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APPENDIX B

PRODUCT NAME SORTED BY APPLICANT


** S **

* SANDOZ INC NEFAZODONE HYDROCHLORIDE, NEFAZODONE HYDROCHLORIDE NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS), NITROFURANTOIN NIZATIDINE, NIZATIDINE OFLOXACIN, OFLOXACIN OMEPRAZOLE, OMEPRAZOLE OMNITROPE, SOMATROPIN RECOMBINANT ONDANSETRON HYDROCHLORIDE, ONDANSETRON HYDROCHLORIDE ONDANSETRON, ONDANSETRON ORPHENADRINE CITRATE, ORPHENADRINE CITRATE ORPHENADRINE CITRATE, ASPIRIN, AND CAFFEINE, ASPIRIN OXACILLIN SODIUM, OXACILLIN SODIUM OXANDROLONE, OXANDROLONE OXAPROZIN, OXAPROZIN OXAZEPAM, OXAZEPAM PENICILLIN G POTASSIUM, PENICILLIN G POTASSIUM PENICILLIN G SODIUM, PENICILLIN G SODIUM PENICILLIN V POTASSIUM, PENICILLIN V POTASSIUM PERPHENAZINE, PERPHENAZINE PHENDIMETRAZINE TARTRATE, PHENDIMETRAZINE TARTRATE PHENTERMINE HYDROCHLORIDE, PHENTERMINE HYDROCHLORIDE PROCHLORPERAZINE MALEATE, PROCHLORPERAZINE MALEATE PROMETHAZINE HYDROCHLORIDE, PROMETHAZINE HYDROCHLORIDE QUINAPRIL HYDROCHLORIDE, QUINAPRIL HYDROCHLORIDE QUINIDINE SULFATE, QUINIDINE SULFATE RAMIPRIL, RAMIPRIL RANITIDINE HYDROCHLORIDE, RANITIDINE HYDROCHLORIDE RESERPINE, RESERPINE RIBAVIRIN, RIBAVIRIN RIFAMPIN, RIFAMPIN RISPERIDONE, RISPERIDONE SERTRALINE HYDROCHLORIDE, SERTRALINE HYDROCHLORIDE SIMVASTATIN, SIMVASTATIN SOTALOL HYDROCHLORIDE, SOTALOL HYDROCHLORIDE SPIRONOLACTONE, SPIRONOLACTONE SULFADIAZINE, SULFADIAZINE SULFAMETHOXAZOLE AND TRIMETHOPRIM DOUBLE STRENGTH, SULFAMETHOXAZOLE SUMATRIPTAN SUCCINATE, SUMATRIPTAN SUCCINATE TACROLIMUS, TACROLIMUS TEMAZEPAM, TEMAZEPAM TERAZOSIN HYDROCHLORIDE, TERAZOSIN HYDROCHLORIDE THIOTHIXENE, THIOTHIXENE TICLOPIDINE HYDROCHLORIDE, TICLOPIDINE HYDROCHLORIDE TIZANIDINE HYDROCHLORIDE, TIZANIDINE HYDROCHLORIDE TOPIRAMATE, TOPIRAMATE TRAMADOL HYDROCHLORIDE, TRAMADOL HYDROCHLORIDE TRIAMTERENE AND HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE TRIFLUOPERAZINE HYDROCHLORIDE, TRIFLUOPERAZINE HYDROCHLORIDE WARFARIN SODIUM, WARFARIN SODIUM
ZONISAMIDE, ZONISAMIDE
SANOFI AVENTIS US * SANOFI AVENTIS US LLC ALLEGRA D 24 HOUR, FEXOFENADINE HYDROCHLORIDE ALLEGRA, FEXOFENADINE HYDROCHLORIDE ALLEGRA-D 12 HOUR, FEXOFENADINE HYDROCHLORIDE AMARYL, GLIMEPIRIDE AMBIEN CR, ZOLPIDEM TARTRATE AMBIEN, ZOLPIDEM TARTRATE ANZEMET, DOLASETRON MESYLATE APIDRA SOLOSTAR, INSULIN GLULISINE RECOMBINANT APIDRA, INSULIN GLULISINE RECOMBINANT ARALEN, CHLOROQUINE PHOSPHATE ARAVA, LEFLUNOMIDE
AVALIDE, HYDROCHLOROTHIAZIDE

SEPTEMBER 2010 - APPROVED DRUG PRODUCTS LIST

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APPENDIX B

PRODUCT NAME SORTED BY APPLICANT


** S **

* SANOFI AVENTIS US LLC AVAPRO, IRBESARTAN BENZACLIN, BENZOYL PEROXIDE BENZAMYCIN PAK, BENZOYL PEROXIDE BENZAMYCIN, BENZOYL PEROXIDE CANTIL, MEPENZOLATE BROMIDE CARAC, FLUOROURACIL CLAFORAN IN DEXTROSE 5% IN PLASTIC CONTAINER, CEFOTAXIME SODIUM CLAFORAN, CEFOTAXIME SODIUM CLOMID, CLOMIPHENE CITRATE DDAVP (NEEDS NO REFRIGERATION), DESMOPRESSIN ACETATE DDAVP, DESMOPRESSIN ACETATE DEMEROL, MEPERIDINE HYDROCHLORIDE DERMATOP E EMOLLIENT, PREDNICARBATE DERMATOP, PREDNICARBATE DIABETA, GLYBURIDE DRISDOL, ERGOCALCIFEROL ELOXATIN, OXALIPLATIN FERRLECIT, SODIUM FERRIC GLUCONATE COMPLEX GAVISCON, ALUMINUM HYDROXIDE (OTC) HIPREX, METHENAMINE HIPPURATE KAYEXALATE, SODIUM POLYSTYRENE SULFONATE KETEK, TELITHROMYCIN KLARON, SULFACETAMIDE SODIUM LANTUS, INSULIN GLARGINE RECOMBINANT LASIX, FUROSEMIDE LOVENOX (PRESERVATIVE FREE), ENOXAPARIN SODIUM LOVENOX, ENOXAPARIN SODIUM MULTAQ, DRONEDARONE HYDROCHLORIDE MYTELASE, AMBENONIUM CHLORIDE NASACORT AQ, TRIAMCINOLONE ACETONIDE NICODERM CQ, NICOTINE (OTC) NILANDRON, NILUTAMIDE NORITATE, METRONIDAZOLE NORPRAMIN, DESIPRAMINE HYDROCHLORIDE OFORTA, FLUDARABINE PHOSPHATE PENLAC, CICLOPIROX PHISOHEX, HEXACHLOROPHENE PLAQUENIL, HYDROXYCHLOROQUINE SULFATE PLAVIX, CLOPIDOGREL BISULFATE PRIFTIN, RIFAPENTINE PRIMAQUINE, PRIMAQUINE PHOSPHATE RIFADIN, RIFAMPIN RIFAMATE, ISONIAZID RIFATER, ISONIAZID RILUTEK, RILUZOLE SKELID, TILUDRONATE DISODIUM TAXOTERE, DOCETAXEL TRENTAL, PENTOXIFYLLINE
UROXATRAL, ALFUZOSIN HYDROCHLORIDE
SANTARUS * SANTARUS INC MAGNESIUM HYDROXIDE AND OMEPRAZOLE AND SODIUM BICARBONATE, ZEGERID, MAGNESIUM HYDROXIDE
ZEGERID, OMEPRAZOLE
SANTEN * SANTEN INC ALAMAST, PEMIROLAST POTASSIUM IQUIX, LEVOFLOXACIN
QUIXIN, LEVOFLOXACIN
SANTEN OY * SANTEN OY BETIMOL,

MAGNESIUM HYDROXIDE

TIMOLOL

SEPTEMBER 2010 - APPROVED DRUG PRODUCTS LIST

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APPENDIX B

PRODUCT NAME SORTED BY APPLICANT


** S **

SAVAGE LABS * SAVAGE LABORATORIES INC DIV ALTANA INC ETHIODOL, ETHIODIZED OIL KAON CL-10, POTASSIUM CHLORIDE
PANDEL, HYDROCORTISONE PROBUTATE
SAVIENT PHARMS * SAVIENT PHARMACEUTICALS INC OXANDRIN, OXANDROLONE SB PHARMCO * SB PHARMCO PUERTO RICO INC AVANDAMET, METFORMIN HYDROCHLORIDE AVANDARYL, GLIMEPIRIDE AVANDIA, ROSIGLITAZONE MALEATE
COREG CR, CARVEDILOL PHOSPHATE
SCHERING * SCHERING CLARINEX-D 12 HOUR, DESLORATADINE * SCHERING CORP ASMANEX TWISTHALER, MOMETASONE FUROATE CLARINEX D 24 HOUR, DESLORATADINE CLARINEX, DESLORATADINE DIPROLENE AF, BETAMETHASONE DIPROPIONATE GUANIDINE HYDROCHLORIDE, GUANIDINE HYDROCHLORIDE INTEGRILIN, EPTIFIBATIDE LOTRISONE, BETAMETHASONE DIPROPIONATE NOXAFIL, POSACONAZOLE POTASSIUM CHLORIDE, POTASSIUM CHLORIDE REBETOL, RIBAVIRIN TEMODAR, TEMOZOLOMIDE
ZEMURON, ROCURONIUM BROMIDE
* SCHERING CORP SUB SCHERING PLOUGH CORP CELESTONE SOLUSPAN, BETAMETHASONE ACETATE CELESTONE, BETAMETHASONE DIPROLENE, BETAMETHASONE DIPROPIONATE
ELOCON, MOMETASONE FUROATE
SCHERING PLOUGH * SCHERING PLOUGH CORP CLARINEX, DESLORATADINE * SCHERING PLOUGH HEALTHCARE PRODUCTS INC AFRINOL, PSEUDOEPHEDRINE SULFATE (OTC) CHILDREN'S CLARITIN, LORATADINE (OTC) CHLOR-TRIMETON, CHLORPHENIRAMINE MALEATE (OTC) CLARITIN HIVES RELIEF REDITAB, LORATADINE (OTC) CLARITIN HIVES RELIEF, LORATADINE (OTC) CLARITIN REDITABS, LORATADINE (OTC) CLARITIN, LORATADINE (OTC) CLARITIN-D 24 HOUR, LORATADINE (OTC) CLARITIN-D, LORATADINE (OTC) DISOPHROL, DEXBROMPHENIRAMINE MALEATE (OTC) DRIXORAL PLUS, ACETAMINOPHEN (OTC) DRIXORAL, DEXBROMPHENIRAMINE MALEATE (OTC) GYNE-LOTRIMIN 3 COMBINATION PACK, CLOTRIMAZOLE (OTC) GYNE-LOTRIMIN 3, CLOTRIMAZOLE (OTC) GYNE-LOTRIMIN COMBINATION PACK, CLOTRIMAZOLE (OTC) GYNE-LOTRIMIN, CLOTRIMAZOLE (OTC) LOTRIMIN ULTRA, BUTENAFINE HYDROCHLORIDE (OTC) MIRALAX, POLYETHYLENE GLYCOL 3350 (OTC) NASONEX, MOMETASONE FUROATE MONOHYDRATE OCUCLEAR, OXYMETAZOLINE HYDROCHLORIDE (OTC) SHADE UVAGUARD, AVOBENZONE (OTC)
ZEGERID OTC, OMEPRAZOLE (OTC)

SEPTEMBER 2010 - APPROVED DRUG PRODUCTS LIST

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APPENDIX B

PRODUCT NAME SORTED BY APPLICANT


** S **

SCHERING PLOUGH RES * SCHERING PLOUGH RESEARCH INSTITUTE LOTRISONE, BETAMETHASONE DIPROPIONATE
REBETOL, RIBAVIRIN
SCHWARZ * SCHWARZ GMBH MONOKET, ISOSORBIDE MONONITRATE SCHWARZ BIOSCIENCES * SCHWARZ BIOSCIENCES INC VIMPAT, LACOSAMIDE SCHWARZ PHARMA * SCHWARZ PHARMA AG EDEX, ALPROSTADIL
GLYCOLAX, POLYETHYLENE GLYCOL 3350
* SCHWARZ PHARMA INC CO-GESIC, ACETAMINOPHEN CORTIFOAM, HYDROCORTISONE ACETATE DILATRATE-SR, ISOSORBIDE DINITRATE EPIFOAM, HYDROCORTISONE ACETATE LEVATOL, PENBUTOLOL SULFATE NIRAVAM, ALPRAZOLAM PARCOPA, CARBIDOPA ROBAXIN, METHOCARBAMOL ROBAXIN-750, METHOCARBAMOL TRILYTE, POLYETHYLENE GLYCOL 3350 UNIRETIC, HYDROCHLOROTHIAZIDE
UNIVASC, MOEXIPRIL HYDROCHLORIDE
SCIOS * SCIOS INC NATRECOR,

NESIRITIDE RECOMBINANT

SEPRACOR * SEPRACOR INC BROVANA, ARFORMOTEROL TARTRATE LUNESTA, ESZOPICLONE XOPENEX HFA, LEVALBUTEROL TARTRATE
XOPENEX, LEVALBUTEROL HYDROCHLORIDE
SEPTODONT * SEPTODONT INC BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE, OCTOCAINE, EPINEPHRINE
SHASUN USA * SHASUN USA INC IBUPROFEN, IBUPROFEN SHIONOGI PHARMA * SHIONOGI PHARMA INC ADRENACLICK, EPINEPHRINE CEDAX, CEFTIBUTEN DIHYDRATE COGNEX, TACRINE HYDROCHLORIDE FENOGLIDE, FENOFIBRATE FURADANTIN, NITROFURANTOIN JENLOGA, CLONIDINE HYDROCHLORIDE ORAPRED ODT, PREDNISOLONE SODIUM PHOSPHATE ORAPRED, PREDNISOLONE SODIUM PHOSPHATE PONSTEL, MEFENAMIC ACID ROBINUL FORTE, GLYCOPYRROLATE ROBINUL, GLYCOPYRROLATE SULAR, NISOLDIPINE TWINJECT 0.15, EPINEPHRINE TWINJECT 0.3, EPINEPHRINE
ULESFIA, BENZYL ALCOHOL

BUPIVACAINE HYDROCHLORIDE

SEPTEMBER 2010 - APPROVED DRUG PRODUCTS LIST

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APPENDIX B

PRODUCT NAME SORTED BY APPLICANT


** S **

SHIRE * SHIRE DEVELOPMENT INC ADDERALL XR 10, AMPHETAMINE ASPARTATE ADDERALL XR 15, AMPHETAMINE ASPARTATE ADDERALL XR 20, AMPHETAMINE ASPARTATE ADDERALL XR 25, AMPHETAMINE ASPARTATE ADDERALL XR 30, AMPHETAMINE ASPARTATE ADDERALL XR 5, AMPHETAMINE ASPARTATE AGRYLIN, ANAGRELIDE HYDROCHLORIDE CARBATROL, CARBAMAZEPINE DAYTRANA, METHYLPHENIDATE FOSRENOL, LANTHANUM CARBONATE INTUNIV, GUANFACINE HYDROCHLORIDE LIALDA, MESALAMINE PENTASA, MESALAMINE PROAMATINE, MIDODRINE HYDROCHLORIDE
SALURON, HYDROFLUMETHIAZIDE
SHIRE DEVELOPMENT * SHIRE DEVELOPMENT INC VYVANSE, LISDEXAMFETAMINE DIMESYLATE SHIRE HUMAN GENETIC * SHIRE HUMAN GENETIC THERAPIES INC VPRIV, VELAGLUCERASE ALFA SIGHT PHARMS * SIGHT PHARMACEUTICALS INC MINOXIDIL (FOR MEN), MINOXIDIL (OTC)
MINOXIDIL (FOR WOMEN), MINOXIDIL (OTC)
SIGMA TAU * SIGMA TAU PHARMACEUTICALS INC ABELCET, AMPHOTERICIN B ADAGEN, PEGADEMASE BOVINE CARNITOR SF, LEVOCARNITINE CARNITOR, LEVOCARNITINE
MATULANE, PROCARBAZINE HYDROCHLORIDE
SIGMAPHARM LABS LLC * SIGMAPHARM LABORATORIES LLC AMILORIDE HYDROCHLORIDE, AMILORIDE HYDROCHLORIDE SILARX * SILARX PHARMACEUTICALS INC AMANTADINE HYDROCHLORIDE, AMANTADINE HYDROCHLORIDE CITALOPRAM HYDROBROMIDE, CITALOPRAM HYDROBROMIDE CLEMASTINE FUMARATE, CLEMASTINE FUMARATE DOXEPIN HYDROCHLORIDE, DOXEPIN HYDROCHLORIDE FLUOXETINE HYDROCHLORIDE, FLUOXETINE HYDROCHLORIDE HALOPERIDOL, HALOPERIDOL LACTATE LEVETIRACETAM, LEVETIRACETAM LORATADINE, LORATADINE (OTC) METAPROTERENOL SULFATE, METAPROTERENOL SULFATE METOCLOPRAMIDE HYDROCHLORIDE, METOCLOPRAMIDE HYDROCHLORIDE
OXYBUTYNIN CHLORIDE, OXYBUTYNIN CHLORIDE
SIRION THERAP * SIRION THERAPEUTICS INC DUREZOL, DIFLUPREDNATE
ZIRGAN, GANCICLOVIR
SKINMEDICA * SKINMEDICA INC VANIQA, EFLORNITHINE HYDROCHLORIDE SKYEPHARMA AG * SKYEPHARMA AG TRIGLIDE, FENOFIBRATE

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APPENDIX B
SLATE PHARMS * SLATE PHARMACEUTICALS INC TESTOPEL, TESTOSTERONE

PRODUCT NAME SORTED BY APPLICANT


** S **

SMITHKLINE BEECHAM * SMITHKLINE BEECHAM LOVAZA, OMEGA-3-ACID ETHYL ESTERS * SMITHKLINE BEECHAM CORP LAMICTAL XR, LAMOTRIGINE * SMITHKLINE BEECHAM CORP DBA GLAXOSMITHKLINE ARRANON, NELARABINE AXID, NIZATIDINE COREG, CARVEDILOL DEXEDRINE, DEXTROAMPHETAMINE SULFATE DYNACIRC CR, ISRADIPINE HYCAMTIN, TOPOTECAN HYDROCHLORIDE INNOPRAN XL, PROPRANOLOL HYDROCHLORIDE LAMICTAL ODT, LAMOTRIGINE LANOXICAPS, DIGOXIN LANOXIN, DIGOXIN LEUKERAN, CHLORAMBUCIL REQUIP XL, ROPINIROLE HYDROCHLORIDE RYTHMOL SR, PROPAFENONE HYDROCHLORIDE RYTHMOL, PROPAFENONE HYDROCHLORIDE
TYKERB, LAPATINIB DITOSYLATE
SOAPCO * SOAPCO INC BRIAN CARE,

CHLORHEXIDINE GLUCONATE

(OTC)

SOLCO HLTHCARE * SOLCO HEALTHCARE US LLC LEVETIRACETAM, LEVETIRACETAM SOLUMED * LES ENTREPRISES SOLUMED INC CHLORASCRUB MAXI SWABSTICK, CHLORHEXIDINE GLUCONATE (OTC) CHLORASCRUB SWAB, CHLORHEXIDINE GLUCONATE (OTC)
CHLORASCRUB SWABSTICK, CHLORHEXIDINE GLUCONATE (OTC)
SOLVAY PHARMS * SOLVAY PHARMACEUTICALS INC ACEON, PERINDOPRIL ERBUMINE SOMAXON * SOMAXON PHARMACEUTICALS INC SILENOR, DOXEPIN HYDROCHLORIDE SOMERSET * SOMERSET PHARMACEUTICALS INC ELDEPRYL, SELEGILINE HYDROCHLORIDE
EMSAM, SELEGILINE
SPEAR PHARMS * SPEAR PHARMACEUTICALS INC FLUOROURACIL, FLUOROURACIL
TRETINOIN, TRETINOIN
SPECTRUM PHARMS * SPECTRUM PHARMACEUTICALS ONDANSETRON HYDROCHLORIDE, ONDANSETRON HYDROCHLORIDE * SPECTRUM PHARMACEUTICALS INC FUSILEV, LEVOLEUCOVORIN CALCIUM STAND HOMEOPATH * STANDARD HOMEOPATHIC CO IVY BLOCK, BENTOQUATAM STASON * STASON INDUSTRIAL CORP ACYCLOVIR, ACYCLOVIR

(OTC)

SEPTEMBER 2010 - APPROVED DRUG PRODUCTS LIST

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APPENDIX B
* STASON INDUSTRIAL CORP CAPTOPRIL, CAPTOPRIL
SELEGILINE HYDROCHLORIDE,

PRODUCT NAME SORTED BY APPLICANT


** S **

SELEGILINE HYDROCHLORIDE

STASON PHARMS * STASON PHARMACEUTICALS INC CYPROHEPTADINE HYDROCHLORIDE,

CYPROHEPTADINE HYDROCHLORIDE

STAT TRADE * STAT TRADE INC BETAMETHASONE VALERATE, BETAMETHASONE VALERATE


NAPRELAN, NAPROXEN SODIUM
STEVENS J * JEROME STEVENS PHARMACEUTICALS INC BUTALBITAL, ASPIRIN, CAFFEINE, AND CODEINE PHOSPHATE, ASPIRIN CEPHALEXIN, CEPHALEXIN DIGOXIN, DIGOXIN METHOCARBAMOL AND ASPIRIN, ASPIRIN ORPHENADRINE CITRATE, ASPIRIN, AND CAFFEINE, ASPIRIN
UNITHROID, LEVOTHYROXINE SODIUM
STI PHARMA LLC * STI PHARMA LLC DEXAMETHASONE, DEXAMETHASONE MYAMBUTOL, ETHAMBUTOL HYDROCHLORIDE
TRIACIN-C, CODEINE PHOSPHATE
STIEFEL * STIEFEL LABORATORIES INC DECLOMYCIN, DEMECLOCYCLINE HYDROCHLORIDE
DUAC, BENZOYL PEROXIDE
STIEFEL GSK * STIEFEL A GSK CO HYDROCORTISONE,

HYDROCORTISONE

STIEFEL LABS INC * STIEFEL LABORATORIES INC E-GLADES, ERYTHROMYCIN EVOCLIN, CLINDAMYCIN PHOSPHATE EXTINA, KETOCONAZOLE OLUX E, CLOBETASOL PROPIONATE SOLAGE, MEQUINOL SORIATANE, ACITRETIN VERDESO, DESONIDE VUSION, MICONAZOLE NITRATE
XOLEGEL, KETOCONAZOLE
STRAKAN * STRAKAN INTERNATIONAL LTD SANCUSO, GRANISETRON STRIDES ARCOLAB LTD * STRIDES ARCOLAB LTD ADENOSINE, ADENOSINE
MELOXICAM, MELOXICAM
SUCAMPO PHARMS * SUCAMPO PHARMACEUTICALS INC AMITIZA, LUBIPROSTONE SUMMERS * SUMMERS LABORATORIES INC CROTAN, CROTAMITON SUN PHARM INDS * SUN PHARMACEUTICAL INDUSTRIES LTD ALENDRONATE SODIUM, ALENDRONATE SODIUM AMIFOSTINE, AMIFOSTINE CARBIDOPA AND LEVODOPA, CARBIDOPA
CARBOPLATIN, CARBOPLATIN

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APPENDIX B

PRODUCT NAME SORTED BY APPLICANT


** S **

* SUN PHARMACEUTICAL INDUSTRIES LTD DIVALPROEX SODIUM, DIVALPROEX SODIUM EXTENDED PHENYTOIN SODIUM, PHENYTOIN SODIUM FOSPHENYTOIN SODIUM, FOSPHENYTOIN SODIUM OCTREOTIDE ACETATE, OCTREOTIDE ACETATE ONDANSETRON, ONDANSETRON OXCARBAZEPINE, OXCARBAZEPINE PAMIDRONATE DISODIUM, PAMIDRONATE DISODIUM PANTOPRAZOLE SODIUM, PANTOPRAZOLE SODIUM RIVASTIGMINE TARTRATE, RIVASTIGMINE TARTRATE SUMATRIPTAN SUCCINATE, SUMATRIPTAN SUCCINATE
TORSEMIDE, TORSEMIDE
SUN PHARM INDS (IN) * SUN PHARMACEUTICAL INDUSTRIES LTD CEPHALEXIN, CEPHALEXIN EXTENDED PHENYTOIN SODIUM, PHENYTOIN SODIUM METFORMIN HYDROCHLORIDE, METFORMIN HYDROCHLORIDE ONDANSETRON HYDROCHLORIDE, ONDANSETRON HYDROCHLORIDE ORTHO-EST, ESTROPIPATE SERTRALINE HYDROCHLORIDE, SERTRALINE HYDROCHLORIDE
ZONISAMIDE, ZONISAMIDE
SUN PHARM INDS INC * SUN PHARMACEUTICAL INDUSTRIES INC BENZONATATE, BENZONATATE BETHANECHOL CHLORIDE, BETHANECHOL CHLORIDE CETIRIZINE HYDROCHLORIDE, CETIRIZINE HYDROCHLORIDE ERGOCALCIFEROL, ERGOCALCIFEROL GEMFIBROZIL, GEMFIBROZIL HYDROCODONE BITARTRATE AND ACETAMINOPHEN, ACETAMINOPHEN HYDROXYZINE HYDROCHLORIDE, HYDROXYZINE HYDROCHLORIDE NICARDIPINE HYDROCHLORIDE, NICARDIPINE HYDROCHLORIDE NIMODIPINE, NIMODIPINE OXYCODONE HYDROCHLORIDE, OXYCODONE HYDROCHLORIDE PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE, CODEINE PHOSPHATE
PROMETHAZINE HYDROCHLORIDE, PROMETHAZINE HYDROCHLORIDE
SUN PHARM INDS LTD * SUN PHARMACEUTICAL INDUSTRIES LTD CAFFEINE CITRATE, CAFFEINE CITRATE CARISOPRODOL, CARISOPRODOL GABAPENTIN, GABAPENTIN ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE, ONDANSETRON HYDROCHLORIDE OXALIPLATIN, OXALIPLATIN QUINAPRIL HYDROCHLORIDE, QUINAPRIL HYDROCHLORIDE
TOPIRAMATE, TOPIRAMATE
SUN PHARMA GLOBAL * SUN PHARMA GLOBAL FZE BUPROPION HYDROCHLORIDE, BUPROPION HYDROCHLORIDE * SUN PHARMA GLOBAL INC BICALUTAMIDE, BICALUTAMIDE IRINOTECAN HYDROCHLORIDE, IRINOTECAN HYDROCHLORIDE KETOROLAC TROMETHAMINE, KETOROLAC TROMETHAMINE LEUPROLIDE ACETATE, LEUPROLIDE ACETATE
VECURONIUM BROMIDE, VECURONIUM BROMIDE
SUPPOSITORIA * SUPPOSITORIA LABORATORIES INC ACETAMINOPHEN, ACETAMINOPHEN SVC PHARMA * SVC PHARMA LP DRONABINOL,

(OTC)

DRONABINOL

SYNCOR PHARMS * SYNCOR PHARMACEUTICALS INC SODIUM IODIDE I 123, SODIUM IODIDE I-123

SEPTEMBER 2010 - APPROVED DRUG PRODUCTS LIST

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APPENDIX B
SYNERX * SYNERX PHARMA LLC MELPHALAN HYDROCHLORIDE, SYNERX PHARMA * SYNERX PHARMA LLC CICLOPIROX, CICLOPIROX FOMEPIZOLE, FOMEPIZOLE MALATHION, MALATHION TESTOSTERONE CYPIONATE, TESTOSTERONE ENANTHATE,

PRODUCT NAME SORTED BY APPLICANT


** S **

MELPHALAN HYDROCHLORIDE

TESTOSTERONE CYPIONATE
TESTOSTERONE ENANTHATE

SYNTHON PHARMS * SYNTHON PHARMACEUTICALS INC AMLODIPINE BESYLATE, AMLODIPINE BESYLATE


BICALUTAMIDE, BICALUTAMIDE
TAKEDA GLOBAL * TAKEDA GLOBAL RESEARCH DEVELOPMENT CENTER INC ACTOPLUS MET XR, METFORMIN HYDROCHLORIDE ACTOPLUS MET, METFORMIN HYDROCHLORIDE DUETACT, GLIMEPIRIDE
ROZEREM, RAMELTEON
TAKEDA PHARMS * TAKEDA PHARMACEUTICALS NORTH AMERICA INC DEXILANT, DEXLANSOPRAZOLE
ULORIC, FEBUXOSTAT
TAKEDA PHARMS NA * TAKEDA PHARMACEUTICALS NORTH AMERICA INC ACTOS, PIOGLITAZONE HYDROCHLORIDE PREVACID, LANSOPRAZOLE
PREVPAC, AMOXICILLIN
TARO * TARO PHARMACEUTICAL INDUSTRIES LTD ACETAZOLAMIDE, ACETAZOLAMIDE CARBAMAZEPINE, CARBAMAZEPINE CARVEDILOL, CARVEDILOL CETIRIZINE HYDROCHLORIDE ALLERGY, CETIRIZINE HYDROCHLORIDE (OTC) CETIRIZINE HYDROCHLORIDE HIVES RELIEF, CETIRIZINE HYDROCHLORIDE (OTC) CETIRIZINE HYDROCHLORIDE, CETIRIZINE HYDROCHLORIDE CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY, CETIRIZINE HYDROCHLORIDE (OTC) CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF, CETIRIZINE HYDROCHLORIDE (OTC) CLOMIPRAMINE HYDROCHLORIDE, CLOMIPRAMINE HYDROCHLORIDE ENALAPRIL MALEATE, ENALAPRIL MALEATE ETODOLAC, ETODOLAC EXTENDED PHENYTOIN SODIUM, PHENYTOIN SODIUM FLUCONAZOLE, FLUCONAZOLE FLUOROURACIL, FLUOROURACIL HYDROCORTISONE BUTYRATE, HYDROCORTISONE BUTYRATE KETOCONAZOLE, KETOCONAZOLE LAMOTRIGINE, LAMOTRIGINE LEVETIRACETAM, LEVETIRACETAM LORATADINE, LORATADINE (OTC) MELOXICAM, MELOXICAM METRONIDAZOLE, METRONIDAZOLE NORTRIPTYLINE HYDROCHLORIDE, NORTRIPTYLINE HYDROCHLORIDE ONDANSETRON HYDROCHLORIDE, ONDANSETRON HYDROCHLORIDE OXCARBAZEPINE, OXCARBAZEPINE
PHENYTOIN, PHENYTOIN
* TARO PHARMACEUTICALS INC BETAMETHASONE DIPROPIONATE, BETAMETHASONE DIPROPIONATE CLOBETASOL PROPIONATE, CLOBETASOL PROPIONATE CLOTRIMAZOLE, CLOTRIMAZOLE CLOTRIMAZOLE, CLOTRIMAZOLE (OTC)
DESOXIMETASONE, DESOXIMETASONE

SEPTEMBER 2010 - APPROVED DRUG PRODUCTS LIST

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APPENDIX B

PRODUCT NAME SORTED BY APPLICANT


** T **

* TARO PHARMACEUTICALS INC DIFLORASONE DIACETATE, DIFLORASONE DIACETATE FLUOCINOLONE ACETONIDE, FLUOCINOLONE ACETONIDE FLUOCINONIDE, FLUOCINONIDE HYDROCORTISONE VALERATE, HYDROCORTISONE VALERATE MICONAZOLE NITRATE, MICONAZOLE NITRATE (OTC) NORTRIPTYLINE HYDROCHLORIDE, NORTRIPTYLINE HYDROCHLORIDE TRIAMCINOLONE ACETONIDE, TRIAMCINOLONE ACETONIDE
WARFARIN SODIUM, WARFARIN SODIUM
* TARO PHARMACEUTICALS USA INC ACETIC ACID, ACETIC ACID, GLACIAL ALCLOMETASONE DIPROPIONATE, ALCLOMETASONE DIPROPIONATE AMIODARONE HYDROCHLORIDE, AMIODARONE HYDROCHLORIDE AMMONIUM LACTATE, AMMONIUM LACTATE BETAMETHASONE DIPROPIONATE, BETAMETHASONE DIPROPIONATE CICLOPIROX, CICLOPIROX CIPROFLOXACIN HYDROCHLORIDE, CIPROFLOXACIN HYDROCHLORIDE CLOBETASOL PROPIONATE (EMOLLIENT), CLOBETASOL PROPIONATE CLOBETASOL PROPIONATE, CLOBETASOL PROPIONATE CLORAZEPATE DIPOTASSIUM, CLORAZEPATE DIPOTASSIUM CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE, BETAMETHASONE DIPROPIONATE CLOTRIMAZOLE, CLOTRIMAZOLE DERMABET, BETAMETHASONE VALERATE DESONIDE, DESONIDE DIFLORASONE DIACETATE, DIFLORASONE DIACETATE ECONAZOLE NITRATE, ECONAZOLE NITRATE FLO-PRED, PREDNISOLONE ACETATE FLUOCINOLONE ACETONIDE, FLUOCINOLONE ACETONIDE FLUOCINONIDE EMULSIFIED BASE, FLUOCINONIDE FLUOCINONIDE, FLUOCINONIDE FLUOROURACIL, FLUOROURACIL GENTAMICIN SULFATE, GENTAMICIN SULFATE HALOBETASOL PROPIONATE, HALOBETASOL PROPIONATE HYDROCORTISONE AND ACETIC ACID, ACETIC ACID, GLACIAL HYDROCORTISONE, HYDROCORTISONE KETOZOLE, KETOCONAZOLE LIDOCAINE, LIDOCAINE LORATADINE, LORATADINE (OTC) MICONAZOLE 3, MICONAZOLE NITRATE (OTC) MOMETASONE FUROATE, MOMETASONE FUROATE MUPIROCIN, MUPIROCIN NYSTATIN AND TRIAMCINOLONE ACETONIDE, NYSTATIN NYSTATIN, NYSTATIN ORACORT, TRIAMCINOLONE ACETONIDE PROMETHAZINE HYDROCHLORIDE, PROMETHAZINE HYDROCHLORIDE SULFACETAMIDE SODIUM, SULFACETAMIDE SODIUM TERBINAFINE HYDROCHLORIDE, TERBINAFINE HYDROCHLORIDE (OTC) TERCONAZOLE, TERCONAZOLE TERIL, CARBAMAZEPINE TRIAMCINOLONE ACETONIDE, TRIAMCINOLONE ACETONIDE TRIVAGIZOLE 3, CLOTRIMAZOLE (OTC)
U-CORT, HYDROCORTISONE ACETATE
TARO PHARM INDS * TARO PHARMACEUTICAL INDUSTRIES LTD AMCINONIDE, AMCINONIDE CARBAMAZEPINE, CARBAMAZEPINE CICLOPIROX, CICLOPIROX CLINDAMYCIN PHOSPHATE, CLINDAMYCIN PHOSPHATE ENALAPRIL MALEATE AND HYDROCHLOROTHIAZIDE, ENALAPRIL MALEATE ETODOLAC, ETODOLAC FLUCONAZOLE, FLUCONAZOLE HYDROCORTISONE BUTYRATE, HYDROCORTISONE BUTYRATE
LAMOTRIGINE, LAMOTRIGINE

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APPENDIX B

PRODUCT NAME SORTED BY APPLICANT


** T **

TARO PHARMS IRELAND * TARO PHARMACEUTICALS IRELAND LTD ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE, ONDANSETRON HYDROCHLORIDE SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, SODIUM CHLORIDE STERILE WATER FOR INJECTION IN PLASTIC CONTAINER, STERILE WATER FOR INJECTION TARO PHARMS NORTH * TARO PHARMACEUTICALS NORTH AMERICA INC OVIDE, MALATHION TOPICORT LP, DESOXIMETASONE
TOPICORT, DESOXIMETASONE
TAYLOR * TAYLOR PHARMACEUTICALS LABETALOL HYDROCHLORIDE, LABETALOL HYDROCHLORIDE MIDAZOLAM HYDROCHLORIDE, MIDAZOLAM HYDROCHLORIDE
NAPHAZOLINE HYDROCHLORIDE, NAPHAZOLINE HYDROCHLORIDE
TAYLOR PHARMA * TAYLOR PHARMACAL CO DILTIAZEM HYDROCHLORIDE, DILTIAZEM HYDROCHLORIDE PROPARACAINE HYDROCHLORIDE, PROPARACAINE HYDROCHLORIDE
TRIMETHOPRIM SULFATE AND POLYMYXIN B SULFATE, POLYMYXIN B SULFATE
TEDOR PHARM * TEDOR PHARMA INC BENZPHETAMINE HYDROCHLORIDE, TEIKOKU PHARMA USA * TEIKOKU PHARMA USA INC LIDODERM, LIDOCAINE TERCICA * TERCICA INC INCRELEX,

BENZPHETAMINE HYDROCHLORIDE

MECASERMIN RECOMBINANT

TEVA * TEVA NEUROSCIENCE INC AZILECT, RASAGILINE MESYLATE


COPAXONE, GLATIRAMER ACETATE
* TEVA PHARMACEUTICALS USA INC ACETAMINOPHEN AND CODEINE PHOSPHATE, ACETAMINOPHEN ACYCLOVIR, ACYCLOVIR ADIPEX-P, PHENTERMINE HYDROCHLORIDE ALBUTEROL SULFATE, ALBUTEROL SULFATE AMLODIPINE BESYLATE, AMLODIPINE BESYLATE AMOXICILLIN AND CLAVULANATE POTASSIUM, AMOXICILLIN AMOXICILLIN PEDIATRIC, AMOXICILLIN AMOXICILLIN, AMOXICILLIN ATENOLOL, ATENOLOL AZITHROMYCIN, AZITHROMYCIN BENAZEPRIL HYDROCHLORIDE, BENAZEPRIL HYDROCHLORIDE BETAMETHASONE DIPROPIONATE, BETAMETHASONE DIPROPIONATE BETA-VAL, BETAMETHASONE VALERATE BICALUTAMIDE, BICALUTAMIDE BUPROPION HYDROCHLORIDE, BUPROPION HYDROCHLORIDE BUSPIRONE HYDROCHLORIDE, BUSPIRONE HYDROCHLORIDE CALCITRIOL, CALCITRIOL CAPTOPRIL AND HYDROCHLOROTHIAZIDE, CAPTOPRIL CAPTOPRIL, CAPTOPRIL CARBIDOPA AND LEVODOPA, CARBIDOPA CARVEDILOL, CARVEDILOL CEFACLOR, CEFACLOR CEFPROZIL, CEFPROZIL CEFTRIAXONE, CEFTRIAXONE SODIUM CEFUROXIME AXETIL, CEFUROXIME AXETIL CEFUROXIME SODIUM, CEFUROXIME SODIUM
CEPHALEXIN, CEPHALEXIN

SEPTEMBER 2010 - APPROVED DRUG PRODUCTS LIST

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APPENDIX B

PRODUCT NAME SORTED BY APPLICANT


** T **

* TEVA PHARMACEUTICALS USA INC CHLORHEXIDINE GLUCONATE, CHLORHEXIDINE GLUCONATE CILOSTAZOL, CILOSTAZOL CIMETIDINE HYDROCHLORIDE, CIMETIDINE HYDROCHLORIDE CIMETIDINE, CIMETIDINE CLARITHROMYCIN, CLARITHROMYCIN CLEMASTINE FUMARATE, CLEMASTINE FUMARATE CLINDAMYCIN HYDROCHLORIDE, CLINDAMYCIN HYDROCHLORIDE CLOMIPRAMINE HYDROCHLORIDE, CLOMIPRAMINE HYDROCHLORIDE CLONAZEPAM, CLONAZEPAM CLOTRIMAZOLE, CLOTRIMAZOLE DICLOFENAC POTASSIUM, DICLOFENAC POTASSIUM DICLOXACILLIN SODIUM, DICLOXACILLIN SODIUM DIFLUNISAL, DIFLUNISAL DILTIAZEM HYDROCHLORIDE, DILTIAZEM HYDROCHLORIDE DISOPYRAMIDE PHOSPHATE, DISOPYRAMIDE PHOSPHATE DIVALPROEX SODIUM, DIVALPROEX SODIUM DOXAZOSIN MESYLATE, DOXAZOSIN MESYLATE ENALAPRIL MALEATE AND HYDROCHLOROTHIAZIDE, ENALAPRIL MALEATE ENALAPRIL MALEATE, ENALAPRIL MALEATE EPITOL, CARBAMAZEPINE ESTAZOLAM, ESTAZOLAM ETODOLAC, ETODOLAC FAMOTIDINE, FAMOTIDINE FAMOTIDINE, FAMOTIDINE (OTC) FENOFIBRATE (MICRONIZED), FENOFIBRATE FENOFIBRATE, FENOFIBRATE FEXOFENADINE HYDROCHLORIDE, FEXOFENADINE HYDROCHLORIDE FINASTERIDE, FINASTERIDE FLUCONAZOLE, FLUCONAZOLE FLUOCINONIDE EMULSIFIED BASE, FLUOCINONIDE FLUOCINONIDE, FLUOCINONIDE FLUOXETINE HYDROCHLORIDE, FLUOXETINE HYDROCHLORIDE FLURBIPROFEN, FLURBIPROFEN FLUVOXAMINE MALEATE, FLUVOXAMINE MALEATE FOSINOPRIL SODIUM, FOSINOPRIL SODIUM GABAPENTIN, GABAPENTIN GALZIN, ZINC ACETATE GEMFIBROZIL, GEMFIBROZIL GLIMEPIRIDE, GLIMEPIRIDE GLYBURIDE (MICRONIZED), GLYBURIDE GLYBURIDE, GLYBURIDE HYDROCODONE BITARTRATE AND IBUPROFEN, HYDROCODONE BITARTRATE ISOSORBIDE MONONITRATE, ISOSORBIDE MONONITRATE KETOCONAZOLE, KETOCONAZOLE KETOPROFEN, KETOPROFEN KETOROLAC TROMETHAMINE, KETOROLAC TROMETHAMINE LAMOTRIGINE, LAMOTRIGINE LOPERAMIDE HYDROCHLORIDE, LOPERAMIDE HYDROCHLORIDE LORATADINE, LORATADINE (OTC) LOSARTAN POTASSIUM, LOSARTAN POTASSIUM LOVASTATIN, LOVASTATIN MESALAMINE, MESALAMINE METFORMIN HYDROCHLORIDE, METFORMIN HYDROCHLORIDE METOCLOPRAMIDE HYDROCHLORIDE, METOCLOPRAMIDE HYDROCHLORIDE METOLAZONE, METOLAZONE METOPROLOL TARTRATE, METOPROLOL TARTRATE METRONIDAZOLE, METRONIDAZOLE MEXILETINE HYDROCHLORIDE, MEXILETINE HYDROCHLORIDE MINOCYCLINE HYDROCHLORIDE, MINOCYCLINE HYDROCHLORIDE MIRTAZAPINE, MIRTAZAPINE MOEXIPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE MOEXIPRIL HYDROCHLORIDE, MOEXIPRIL HYDROCHLORIDE MUPIROCIN, MUPIROCIN
NABUMETONE, NABUMETONE

SEPTEMBER 2010 - APPROVED DRUG PRODUCTS LIST

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APPENDIX B

PRODUCT NAME SORTED BY APPLICANT


** T **

* TEVA PHARMACEUTICALS USA INC NAPROXEN SODIUM, NAPROXEN SODIUM NAPROXEN, NAPROXEN NEFAZODONE HYDROCHLORIDE, NEFAZODONE HYDROCHLORIDE NEOMYCIN SULFATE, NEOMYCIN SULFATE NICARDIPINE HYDROCHLORIDE, NICARDIPINE HYDROCHLORIDE NIZATIDINE, NIZATIDINE NORTRIPTYLINE HYDROCHLORIDE, NORTRIPTYLINE HYDROCHLORIDE NYSTATIN, NYSTATIN OFLOXACIN, OFLOXACIN ONDANSETRON HYDROCHLORIDE, ONDANSETRON HYDROCHLORIDE ONDANSETRON, ONDANSETRON ORAP, PIMOZIDE OXAPROZIN, OXAPROZIN PANTOPRAZOLE SODIUM, PANTOPRAZOLE SODIUM PAROXETINE HYDROCHLORIDE, PAROXETINE HYDROCHLORIDE PENICILLIN-VK, PENICILLIN V POTASSIUM PIROXICAM, PIROXICAM PRAVASTATIN SODIUM, PRAVASTATIN SODIUM PRELONE, PREDNISOLONE PROPOXYPHENE HYDROCHLORIDE, PROPOXYPHENE HYDROCHLORIDE PROPOXYPHENE NAPSYLATE AND ACETAMINOPHEN, ACETAMINOPHEN PURINETHOL, MERCAPTOPURINE QUINAPRIL HYDROCHLORIDE, QUINAPRIL HYDROCHLORIDE RANITIDINE HYDROCHLORIDE, RANITIDINE HYDROCHLORIDE RIBAVIRIN, RIBAVIRIN RISPERIDONE, RISPERIDONE ROPINIROLE HYDROCHLORIDE, ROPINIROLE HYDROCHLORIDE SERTRALINE HYDROCHLORIDE, SERTRALINE HYDROCHLORIDE SOTALOL HYDROCHLORIDE, SOTALOL HYDROCHLORIDE SUCRALFATE, SUCRALFATE SULFAMETHOXAZOLE AND TRIMETHOPRIM DOUBLE STRENGTH, SULFAMETHOXAZOLE SUMATRIPTAN SUCCINATE, SUMATRIPTAN SUCCINATE TAMOXIFEN CITRATE, TAMOXIFEN CITRATE TERBINAFINE HYDROCHLORIDE, TERBINAFINE HYDROCHLORIDE TICLOPIDINE HYDROCHLORIDE, TICLOPIDINE HYDROCHLORIDE TIZANIDINE HYDROCHLORIDE, TIZANIDINE HYDROCHLORIDE TOLMETIN SODIUM, TOLMETIN SODIUM TOPIRAMATE, TOPIRAMATE TORSEMIDE, TORSEMIDE TRAMADOL HYDROCHLORIDE, TRAMADOL HYDROCHLORIDE TRIACET, TRIAMCINOLONE ACETONIDE TRIMETHOPRIM, TRIMETHOPRIM VENLAFAXINE HYDROCHLORIDE, VENLAFAXINE HYDROCHLORIDE
ZOLPIDEM TARTRATE, ZOLPIDEM TARTRATE
TEVA BRANDED PHARM * TEVA BRANDED PHARMACEUTICAL PRODUCTS R&D INC NASAREL, FLUNISOLIDE QVAR 40, BECLOMETHASONE DIPROPIONATE
QVAR 80, BECLOMETHASONE DIPROPIONATE
TEVA GLOBAL * TEVA GLOBAL RESPIRATORY RESEARCH LLC PROAIR HFA, ALBUTEROL SULFATE
PROGLYCEM, DIAZOXIDE
TEVA PARENTERAL * TEVA PARENTERAL MEDICINES INC ACYCLOVIR SODIUM, ACYCLOVIR SODIUM ADENOSINE, ADENOSINE ALBUTEROL SULFATE AND IPRATROPIUM BROMIDE, ALBUTEROL SULFATE, ALBUTEROL SULFATE ALPROSTADIL, ALPROSTADIL AMIKACIN SULFATE, AMIKACIN SULFATE
AMINOPHYLLINE, AMINOPHYLLINE

ALBUTEROL SULFATE

SEPTEMBER 2010 - APPROVED DRUG PRODUCTS LIST

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APPENDIX B

PRODUCT NAME SORTED BY APPLICANT


** T **

* TEVA PARENTERAL MEDICINES INC AMIODARONE HYDROCHLORIDE, AMIODARONE HYDROCHLORIDE AMPHOTERICIN B, AMPHOTERICIN B AZITHROMYCIN, AZITHROMYCIN BLEOMYCIN SULFATE, BLEOMYCIN SULFATE BRIMONIDINE TARTRATE, BRIMONIDINE TARTRATE BUDESONIDE, BUDESONIDE BUMETANIDE, BUMETANIDE CALCITRIOL, CALCITRIOL CARBOPLATIN, CARBOPLATIN CEFTRIAXONE, CEFTRIAXONE SODIUM CIMETIDINE HYDROCHLORIDE, CIMETIDINE HYDROCHLORIDE CIPROFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER, CIPROFLOXACIN CIPROFLOXACIN, CIPROFLOXACIN CISPLATIN, CISPLATIN CROMOLYN SODIUM, CROMOLYN SODIUM CYTOSAR-U, CYTARABINE DACARBAZINE, DACARBAZINE DAUNORUBICIN HYDROCHLORIDE, DAUNORUBICIN HYDROCHLORIDE DESMOPRESSIN ACETATE, DESMOPRESSIN ACETATE DEXAMETHASONE SODIUM PHOSPHATE, DEXAMETHASONE SODIUM PHOSPHATE DILTIAZEM HYDROCHLORIDE, DILTIAZEM HYDROCHLORIDE DIPYRIDAMOLE, DIPYRIDAMOLE DOBUTAMINE HYDROCHLORIDE, DOBUTAMINE HYDROCHLORIDE DOXORUBICIN HYDROCHLORIDE, DOXORUBICIN HYDROCHLORIDE ENALAPRILAT, ENALAPRILAT EPIRUBICIN HYDROCHLORIDE, EPIRUBICIN HYDROCHLORIDE EPOPROSTENOL SODIUM, EPOPROSTENOL SODIUM ERYTHROMYCIN LACTOBIONATE, ERYTHROMYCIN LACTOBIONATE ETOPOSIDE, ETOPOSIDE FENOLDOPAM MESYLATE, FENOLDOPAM MESYLATE FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, FLUCONAZOLE FLUCONAZOLE IN SODIUM CHLORIDE 0.9%, FLUCONAZOLE FLUDARABINE PHOSPHATE, FLUDARABINE PHOSPHATE FLUMAZENIL, FLUMAZENIL FLUOROURACIL, FLUOROURACIL FLUPHENAZINE DECANOATE, FLUPHENAZINE DECANOATE FOSPHENYTOIN SODIUM, FOSPHENYTOIN SODIUM GRANISETRON HYDROCHLORIDE PRESERVATIVE FREE, GRANISETRON HYDROCHLORIDE GRANISETRON HYDROCHLORIDE, GRANISETRON HYDROCHLORIDE HALOPERIDOL DECANOATE, HALOPERIDOL DECANOATE HALOPERIDOL, HALOPERIDOL LACTATE IDARUBICIN HYDROCHLORIDE PFS, IDARUBICIN HYDROCHLORIDE IDARUBICIN HYDROCHLORIDE, IDARUBICIN HYDROCHLORIDE IFOSFAMIDE, IFOSFAMIDE IFOSFAMIDE/MESNA KIT, IFOSFAMIDE IPRATROPIUM BROMIDE, IPRATROPIUM BROMIDE IRINOTECAN HYDROCHLORIDE, IRINOTECAN HYDROCHLORIDE LEUCOVORIN CALCIUM, LEUCOVORIN CALCIUM LEUPROLIDE ACETATE, LEUPROLIDE ACETATE LEVOCARNITINE, LEVOCARNITINE MEDROXYPROGESTERONE ACETATE, MEDROXYPROGESTERONE ACETATE MESNA, MESNA METHYLDOPATE HYDROCHLORIDE, METHYLDOPATE HYDROCHLORIDE METHYLPREDNISOLONE ACETATE, METHYLPREDNISOLONE ACETATE METHYLPREDNISOLONE SODIUM SUCCINATE, METHYLPREDNISOLONE SODIUM SUCCINATE METOCLOPRAMIDE HYDROCHLORIDE, METOCLOPRAMIDE HYDROCHLORIDE MITOXANTRONE HYDROCHLORIDE, MITOXANTRONE HYDROCHLORIDE NICARDIPINE HYDROCHLORIDE, NICARDIPINE HYDROCHLORIDE NOREPINEPHRINE BITARTRATE, NOREPINEPHRINE BITARTRATE OCTREOTIDE ACETATE, OCTREOTIDE ACETATE ONDANSETRON HYDROCHLORIDE AND DEXTROSE IN PLASTIC CONTAINER, ONDANSETRON HYDROCHLORIDE OXALIPLATIN, OXALIPLATIN OXYTOCIN, OXYTOCIN
PACLITAXEL, PACLITAXEL

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APPENDIX B

PRODUCT NAME SORTED BY APPLICANT


** T **

* TEVA PARENTERAL MEDICINES INC PAMIDRONATE DISODIUM, PAMIDRONATE DISODIUM PANCURONIUM BROMIDE, PANCURONIUM BROMIDE PROMETHAZINE HYDROCHLORIDE, PROMETHAZINE HYDROCHLORIDE PROPOFOL, PROPOFOL ROCURONIUM BROMIDE, ROCURONIUM BROMIDE SODIUM NITROPRUSSIDE, SODIUM NITROPRUSSIDE SULFAMETHOXAZOLE AND TRIMETHOPRIM, SULFAMETHOXAZOLE SUMATRIPTAN SUCCINATE, SUMATRIPTAN SUCCINATE TERBUTALINE SULFATE, TERBUTALINE SULFATE THIOTEPA, THIOTEPA TOBRAMYCIN SULFATE, TOBRAMYCIN SULFATE VECURONIUM BROMIDE, VECURONIUM BROMIDE VINCRISTINE SULFATE PFS, VINCRISTINE SULFATE VINORELBINE TARTRATE, VINORELBINE TARTRATE
ZANOSAR, STREPTOZOCIN
TEVA PARNTL * TEVA PARENTAL MEDICINE INC DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE,

DORZOLAMIDE HYDROCHLORIDE

TEVA PHARMS * TEVA PHARMACEUTICALS USA ALENDRONATE SODIUM, ALENDRONATE SODIUM ALPRAZOLAM, ALPRAZOLAM AMIODARONE HYDROCHLORIDE, AMIODARONE HYDROCHLORIDE AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE, AMLODIPINE BESYLATE AZITHROMYCIN, AZITHROMYCIN BISOPROLOL FUMARATE, BISOPROLOL FUMARATE CEFADROXIL, CEFADROXIL/CEFADROXIL HEMIHYDRATE CEFDINIR, CEFDINIR CEFPROZIL, CEFPROZIL CETIRIZINE HYDROCHLORIDE, CETIRIZINE HYDROCHLORIDE CICLOPIROX, CICLOPIROX CLOBETASOL PROPIONATE, CLOBETASOL PROPIONATE DESMOPRESSIN ACETATE, DESMOPRESSIN ACETATE DEXMETHYLPHENIDATE HYDROCHLORIDE, DEXMETHYLPHENIDATE HYDROCHLORIDE DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE, ASPARTATE DIVALPROEX SODIUM, DIVALPROEX SODIUM
DORZOLAMIDE HYDROCHLORIDE, DORZOLAMIDE HYDROCHLORIDE
DOXEPIN HYDROCHLORIDE, DOXEPIN HYDROCHLORIDE
ETHOSUXIMIDE, ETHOSUXIMIDE
FAMCICLOVIR, FAMCICLOVIR
FENTANYL-100, FENTANYL
FENTANYL-25, FENTANYL
FENTANYL-50, FENTANYL
FENTANYL-75, FENTANYL
GABAPENTIN, GABAPENTIN
GALANTAMINE HYDROBROMIDE, GALANTAMINE HYDROBROMIDE
GLIPIZIDE AND METFORMIN HYDROCHLORIDE, GLIPIZIDE
GRANISETRON HYDROCHLORIDE, GRANISETRON HYDROCHLORIDE
HALOPERIDOL, HALOPERIDOL LACTATE
HYDROCORTISONE, HYDROCORTISONE
HYDROXYCHLOROQUINE SULFATE, HYDROXYCHLOROQUINE SULFATE
LANSOPRAZOLE, LANSOPRAZOLE
LEFLUNOMIDE, LEFLUNOMIDE
LEVETIRACETAM, LEVETIRACETAM
LIDOCAINE HYDROCHLORIDE, LIDOCAINE HYDROCHLORIDE
LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE
MEBENDAZOLE, MEBENDAZOLE
MEGESTROL ACETATE, MEGESTROL ACETATE
MELOXICAM, MELOXICAM
METHAZOLAMIDE, METHAZOLAMIDE
MYCOPHENOLATE MOFETIL, MYCOPHENOLATE MOFETIL
NATEGLINIDE, NATEGLINIDE

AMPHETAMINE

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PRODUCT NAME SORTED BY APPLICANT


** T **

* TEVA PHARMACEUTICALS USA OXCARBAZEPINE, OXCARBAZEPINE PRAVASTATIN SODIUM, PRAVASTATIN SODIUM PROCHLORPERAZINE MALEATE, PROCHLORPERAZINE MALEATE QUINIDINE SULFATE, QUINIDINE SULFATE RAMIPRIL, RAMIPRIL RISEDRONATE SODIUM, RISEDRONATE SODIUM SULFAMETHOXAZOLE AND TRIMETHOPRIM, SULFAMETHOXAZOLE TAMOXIFEN CITRATE, TAMOXIFEN CITRATE TRANDOLAPRIL, TRANDOLAPRIL URSODIOL, URSODIOL VALPROIC ACID, VALPROIC ACID VANDAZOLE, METRONIDAZOLE
ZALEPLON, ZALEPLON
THE PHARMA NETWORK * THE PHARMA NETWORK LLC BENZONATATE, BENZONATATE THE PHARMANETWORK * THE PHARMANETWORK LLC METHADONE HYDROCHLORIDE, THERAKOS * THERAKOS INC UVADEX, METHOXSALEN THERAVANCE INC * THERAVANCE INC VIBATIV, TELAVANCIN HYDROCHLORIDE THREE RIVERS PHARMS * THREE RIVERS PHARMACEUTICALS LLC AMPHOTEC, AMPHOTERICIN B RIBASPHERE, RIBAVIRIN
RIBAVIRIN, RIBAVIRIN
TIBOTEC * TIBOTEC INC INTELENCE,

METHADONE HYDROCHLORIDE

ETRAVIRINE

TOLMAR * TOLMAR INC ATRIDOX, DOXYCYCLINE HYCLATE BETAMETHASONE DIPROPIONATE, BETAMETHASONE DIPROPIONATE CALCIPOTRIENE, CALCIPOTRIENE CICLOPIROX, CICLOPIROX CLOBETASOL PROPIONATE, CLOBETASOL PROPIONATE ERYTHROMYCIN AND BENZOYL PEROXIDE, BENZOYL PEROXIDE FLUTICASONE PROPIONATE, FLUTICASONE PROPIONATE KETOCONAZOLE, KETOCONAZOLE LEVETIRACETAM, LEVETIRACETAM LIDOCAINE AND PRILOCAINE, LIDOCAINE METRONIDAZOLE, METRONIDAZOLE
MOMETASONE FUROATE, MOMETASONE FUROATE
TOLMAR THERAP * TOLMAR THERAPEUTICS INC ELIGARD, LEUPROLIDE ACETATE TOPOTARGET * TOPOTARGET AS TOTECT, DEXRAZOXANE HYDROCHLORIDE TORPHARM * TORPHARM INC RANITIDINE HYDROCHLORIDE, TORRENT PHARM * TORRENT PHARMA INC METFORMIN HYDROCHLORIDE,

RANITIDINE HYDROCHLORIDE

(OTC)

METFORMIN HYDROCHLORIDE

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APPENDIX B

PRODUCT NAME SORTED BY APPLICANT


** T **

TORRENT PHARMS * TORRENT PHARMACEUTICALS LTD AMLODIPINE BESYLATE, AMLODIPINE BESYLATE CARBAMAZEPINE, CARBAMAZEPINE CITALOPRAM HYDROBROMIDE, CITALOPRAM HYDROBROMIDE LAMOTRIGINE, LAMOTRIGINE LEVETIRACETAM, LEVETIRACETAM LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE METFORMIN HYDROCHLORIDE, METFORMIN HYDROCHLORIDE RISPERIDONE, RISPERIDONE SERTRALINE HYDROCHLORIDE, SERTRALINE HYDROCHLORIDE TOPIRAMATE, TOPIRAMATE
ZOLPIDEM TARTRATE, ZOLPIDEM TARTRATE
TORRENT PHARMS LLC * TORRENT PHARMACEUTICALS LLC CETIRIZINE HYDROCHLORIDE ALLERGY, CETIRIZINE HYDROCHLORIDE (OTC) CETIRIZINE HYDROCHLORIDE HIVES RELIEF, CETIRIZINE HYDROCHLORIDE (OTC) TRIAX PHARMS LLC * TRIAX PHARMACEUTICALS LLC LOCOID LIPOCREAM, HYDROCORTISONE BUTYRATE LOCOID, HYDROCORTISONE BUTYRATE MINOCIN, MINOCYCLINE HYDROCHLORIDE
TRETINOIN, TRETINOIN
TRIS PHARMA * TRIS PHARMA INC CLONIDINE, CLONIDINE TRIS PHARMA INC * TRIS PHARMA INC IBUPROFEN, IBUPROFEN

(OTC)

TYCO HLTHCARE * TYCO HEALTHCARE GROUP LP ANAFRANIL, CLOMIPRAMINE HYDROCHLORIDE PAMELOR, NORTRIPTYLINE HYDROCHLORIDE RESTORIL, TEMAZEPAM TOFRANIL, IMIPRAMINE HYDROCHLORIDE
TOFRANIL-PM, IMIPRAMINE PAMOATE
* TYCO HEALTHCARE MALLINCKRODT BENZPHETAMINE HYDROCHLORIDE, BENZPHETAMINE HYDROCHLORIDE HYDROMORPHONE HYDROCHLORIDE, HYDROMORPHONE HYDROCHLORIDE OXYCODONE HYDROCHLORIDE, OXYCODONE HYDROCHLORIDE
TUSSICAPS, CHLORPHENIRAMINE POLISTIREX
UCB INC * UCB INC DIPENTUM, OLSALAZINE SODIUM KEPPRA XR, LEVETIRACETAM KEPPRA, LEVETIRACETAM LORTAB, ACETAMINOPHEN METADATE CD, METHYLPHENIDATE HYDROCHLORIDE METADATE ER, METHYLPHENIDATE HYDROCHLORIDE METHYLPHENIDATE HYDROCHLORIDE, METHYLPHENIDATE HYDROCHLORIDE PEDIAPRED, PREDNISOLONE SODIUM PHOSPHATE PROCTOFOAM HC, HYDROCORTISONE ACETATE SEMPREX-D, ACRIVASTINE THEO-24, THEOPHYLLINE TUSSIONEX PENNKINETIC, CHLORPHENIRAMINE POLISTIREX XYZAL, LEVOCETIRIZINE DIHYDROCHLORIDE
ZAROXOLYN, METOLAZONE
UCYCLYD * UCYCLYD PHARMA INC AMMONUL, SODIUM BENZOATE

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APPENDIX B

PRODUCT NAME SORTED BY APPLICANT


** U **

UDL LABS * UDL LABORATORIES SULFAMYLON, MAFENIDE ACETATE ULURU * ULURU INC APHTHASOL,

AMLEXANOX

UNICHEM * UNICHEM LABORATORIES LTD CETIRIZINE HYDROCHLORIDE ALLERGY, CETIRIZINE HYDROCHLORIDE (OTC) CETIRIZINE HYDROCHLORIDE HIVES, CETIRIZINE HYDROCHLORIDE (OTC) CLONIDINE HYDROCHLORIDE, CLONIDINE HYDROCHLORIDE HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE MELOXICAM, MELOXICAM TOPIRAMATE, TOPIRAMATE
ZALEPLON, ZALEPLON
UNICHEM PHARMS (USA) * UNICHEM PHARMACEUTICALS (USA) INC BISOPROLOL FUMARATE, BISOPROLOL FUMARATE UNIMED * UNIMED INC MARINOL,

DRONABINOL

UNIMED PHARMS * UNIMED PHARMACEUTICALS INC ANDROGEL, TESTOSTERONE UNIMED PHARMS LLC * UNIMED PHARMACEUTICALS LLC PROMETRIUM, PROGESTERONE UNIQUE PHARM LABS * UNIQUE PHARMACEUTICAL LABORATORIES ATENOLOL, ATENOLOL CETIRIZINE HYDROCHLORIDE ALLERGY, CETIRIZINE HYDROCHLORIDE (OTC) CETIRIZINE HYDROCHLORIDE HIVES, CETIRIZINE HYDROCHLORIDE (OTC) CIPROFLOXACIN HYDROCHLORIDE, CIPROFLOXACIN HYDROCHLORIDE DICLOFENAC SODIUM, DICLOFENAC SODIUM
FLUCONAZOLE, FLUCONAZOLE
UNITED GUARDIAN * UNITED GUARDIAN INC RENACIDIN, CITRIC ACID UNITED THERAP * UNITED THERAPEUTICS CORP REMODULIN, TREPROSTINIL SODIUM
TYVASO, TREPROSTINIL SODIUM
UPSHER SMITH * UPSHER SMITH LABORATORIES INC AMLODIPINE BESYLATE, AMLODIPINE BESYLATE BETHANECHOL CHLORIDE, BETHANECHOL CHLORIDE DIVALPROEX SODIUM, DIVALPROEX SODIUM DIVIGEL, ESTRADIOL FORTICAL, CALCITONIN SALMON RECOMBINANT KLOR-CON M10, POTASSIUM CHLORIDE KLOR-CON M15, POTASSIUM CHLORIDE KLOR-CON M20, POTASSIUM CHLORIDE KLOR-CON, POTASSIUM CHLORIDE LAMOTRIGINE, LAMOTRIGINE NIACOR, NIACIN NYSTATIN, NYSTATIN ORVATEN, MIDODRINE HYDROCHLORIDE OXANDROLONE, OXANDROLONE PACERONE, AMIODARONE HYDROCHLORIDE
PENTOXIL, PENTOXIFYLLINE

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APPENDIX B

PRODUCT NAME SORTED BY APPLICANT


** U **

* UPSHER SMITH LABORATORIES INC PREVALITE, CHOLESTYRAMINE PROPRANOLOL HYDROCHLORIDE, PROPRANOLOL HYDROCHLORIDE SORINE, SOTALOL HYDROCHLORIDE TOPIRAMATE, TOPIRAMATE
ZALEPLON, ZALEPLON
US SURGCL * UNITED STATES SURGICAL DIV TYCO HEALTHCARE GROUP LP LYMPHAZURIN, ISOSULFAN BLUE US WORLDMEDS * US WORLDMEDS LLC DANTROLENE SODIUM,

DANTROLENE SODIUM

USL PHARMA * USL PHARMA INC AMANTADINE HYDROCHLORIDE, AMANTADINE HYDROCHLORIDE BACLOFEN, BACLOFEN BENZTROPINE MESYLATE, BENZTROPINE MESYLATE CHLORDIAZEPOXIDE HYDROCHLORIDE, CHLORDIAZEPOXIDE HYDROCHLORIDE CHLORPROMAZINE HYDROCHLORIDE, CHLORPROMAZINE HYDROCHLORIDE ESTRADIOL, ESTRADIOL FLUOXYMESTERONE, FLUOXYMESTERONE JANTOVEN, WARFARIN SODIUM MEDROXYPROGESTERONE ACETATE, MEDROXYPROGESTERONE ACETATE
OXYBUTYNIN CHLORIDE, OXYBUTYNIN CHLORIDE
VALEANT * VALEANT PHARMACEUTICALS INTERNATIONAL ANCOBON, FLUCYTOSINE BONTRIL PDM, PHENDIMETRAZINE TARTRATE BONTRIL, PHENDIMETRAZINE TARTRATE
CAPITAL AND CODEINE, ACETAMINOPHEN
D.H.E. 45, DIHYDROERGOTAMINE MESYLATE
DIASTAT ACUDIAL, DIAZEPAM
DIASTAT, DIAZEPAM
FLUOROURACIL, FLUOROURACIL
MIGRANAL, DIHYDROERGOTAMINE MESYLATE
MOTOFEN, ATROPINE SULFATE
MYSOLINE, PRIMIDONE
PHRENILIN FORTE, ACETAMINOPHEN
PHRENILIN WITH CAFFEINE AND CODEINE, ACETAMINOPHEN
PHRENILIN, ACETAMINOPHEN
VALEANT PHARM INTL * VALEANT PHARMACEUTICALS INTERNATIONAL 8-MOP, METHOXSALEN ANDROID 10, METHYLTESTOSTERONE ANDROID 25, METHYLTESTOSTERONE DALMANE, FLURAZEPAM HYDROCHLORIDE EFUDEX, FLUOROURACIL LEVO-DROMORAN, LEVORPHANOL TARTRATE LIBRIUM, CHLORDIAZEPOXIDE HYDROCHLORIDE LIMBITROL DS, AMITRIPTYLINE HYDROCHLORIDE LIMBITROL, AMITRIPTYLINE HYDROCHLORIDE MESTINON, PYRIDOSTIGMINE BROMIDE OXSORALEN, METHOXSALEN OXSORALEN-ULTRA, METHOXSALEN TASMAR, TOLCAPONE TENSILON PRESERVATIVE FREE, EDROPHONIUM CHLORIDE TENSILON, EDROPHONIUM CHLORIDE TESTRED, METHYLTESTOSTERONE VIRAZOLE, RIBAVIRIN
ZELAPAR, SELEGILINE HYDROCHLORIDE

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APPENDIX B
VALIDUS PHARMS * VALIDUS PHARMACEUTICALS LLC ROCALTROL, CALCITRIOL VALIDUS PHARMS INC * VALIDUS PHARMACEUTICALS INC EQUETRO, CARBAMAZEPINE
MARPLAN, ISOCARBOXAZID
VANDA PHARMS INC * VANDA PHARMACEUTICALS INC FANAPT, ILOPERIDONE

PRODUCT NAME SORTED BY APPLICANT


** V **

VEROSCIENCE * VEROSCIENCE LLC CYCLOSET, BROMOCRIPTINE MESYLATE VERSAPHARM * VERSAPHARM INC CICLOPIROX, CICLOPIROX
RIFAMPIN, RIFAMPIN
VICTORY PHARMA * VICTORY PHARMA INC TRAMADOL HYDROCHLORIDE,

TRAMADOL HYDROCHLORIDE

VICURON * VICURON PHARMACEUTICALS INC ERAXIS, ANIDULAFUNGIN VIIV HLTHCARE * VIIV HEALTHCARE CO COMBIVIR, LAMIVUDINE EPIVIR, LAMIVUDINE EPZICOM, ABACAVIR SULFATE LEXIVA, FOSAMPRENAVIR CALCIUM RESCRIPTOR, DELAVIRDINE MESYLATE RETROVIR, ZIDOVUDINE SELZENTRY, MARAVIROC TRIZIVIR, ABACAVIR SULFATE
ZIAGEN, ABACAVIR SULFATE
VINTAGE * VINTAGE PHARMACEUTICALS LLC ACETAMINOPHEN AND CODEINE PHOSPHATE, ACETAMINOPHEN ACETIC ACID, ACETIC ACID, GLACIAL ALBUTEROL SULFATE, ALBUTEROL SULFATE ALPRAZOLAM, ALPRAZOLAM AMANTADINE HYDROCHLORIDE, AMANTADINE HYDROCHLORIDE AMLODIPINE BESYLATE, AMLODIPINE BESYLATE BENZTROPINE MESYLATE, BENZTROPINE MESYLATE CETIRIZINE HYDROCHLORIDE, CETIRIZINE HYDROCHLORIDE CLONIDINE HYDROCHLORIDE, CLONIDINE HYDROCHLORIDE DIVALPROEX SODIUM, DIVALPROEX SODIUM GLYCOPYRROLATE, GLYCOPYRROLATE HYDROCORTISONE AND ACETIC ACID, ACETIC ACID, GLACIAL HYDROCORTISONE, HYDROCORTISONE LIDOCAINE HYDROCHLORIDE VISCOUS, LIDOCAINE HYDROCHLORIDE LIDOCAINE HYDROCHLORIDE, LIDOCAINE HYDROCHLORIDE LISINOPRIL, LISINOPRIL NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE, ETHINYL ESTRADIOL NYSTATIN, NYSTATIN PHENYLEPHRINE HYDROCHLORIDE AND PROMETHAZINE HYDROCHLORIDE, PHENYLEPHRINE HYDROCHLORIDE PREDNISOLONE SODIUM PHOSPHATE, PREDNISOLONE SODIUM PHOSPHATE PREDNISOLONE, PREDNISOLONE PREVIFEM, ETHINYL ESTRADIOL PROMETH HYDROCHLORIDE,PHENYLEPHRINE HYDROCHLORIDE W/CODEINE PHOSPHATE, CODEINE PHOSPHATE PROMETHAZINE DM, DEXTROMETHORPHAN HYDROBROMIDE
PROMETHAZINE HYDROCHLORIDE, PROMETHAZINE HYDROCHLORIDE

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APPENDIX B

PRODUCT NAME SORTED BY APPLICANT


** V **

* VINTAGE PHARMACEUTICALS LLC PROMETHAZINE WITH CODEINE, CODEINE PHOSPHATE RISPERIDONE, RISPERIDONE SPIRONOLACTONE, SPIRONOLACTONE SULFAMETHOXAZOLE AND TRIMETHOPRIM, SULFAMETHOXAZOLE TRAZODONE HYDROCHLORIDE, TRAZODONE HYDROCHLORIDE TRIAMCINOLONE ACETONIDE, TRIAMCINOLONE ACETONIDE TRI-PREVIFEM, ETHINYL ESTRADIOL VALPROIC ACID, VALPROIC ACID
ZOLPIDEM TARTRATE, ZOLPIDEM TARTRATE
VINTAGE PHARMS * VINTAGE PHARMACEUTICALS INC ACETAMINOPHEN AND CODEINE PHOSPHATE, ACETAMINOPHEN ALLOPURINOL, ALLOPURINOL AMITRIPTYLINE HYDROCHLORIDE, AMITRIPTYLINE HYDROCHLORIDE BACLOFEN, BACLOFEN BUTALBITAL, ACETAMINOPHEN AND CAFFEINE, ACETAMINOPHEN BUTALBITAL, ACETAMINOPHEN, CAFFEINE AND CODEINE PHOSPHATE, ACETAMINOPHEN CARISOPRODOL, CARISOPRODOL CLONAZEPAM, CLONAZEPAM CYCLOBENZAPRINE HYDROCHLORIDE, CYCLOBENZAPRINE HYDROCHLORIDE DIAZEPAM, DIAZEPAM DOXYCYCLINE HYCLATE, DOXYCYCLINE HYCLATE FUROSEMIDE, FUROSEMIDE HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE HYDROCODONE BITARTRATE AND ACETAMINOPHEN, ACETAMINOPHEN HYDROCODONE BITARTRATE AND IBUPROFEN, HYDROCODONE BITARTRATE HYDROCORTISONE, HYDROCORTISONE HYDROXYZINE HYDROCHLORIDE, HYDROXYZINE HYDROCHLORIDE IBUPROFEN, IBUPROFEN IBUPROFEN, IBUPROFEN (OTC) LACTULOSE, LACTULOSE LORAZEPAM, LORAZEPAM MECLIZINE HYDROCHLORIDE, MECLIZINE HYDROCHLORIDE MEPERIDINE HYDROCHLORIDE, MEPERIDINE HYDROCHLORIDE METHOCARBAMOL, METHOCARBAMOL METHYLPREDNISOLONE, METHYLPREDNISOLONE METOCLOPRAMIDE HYDROCHLORIDE, METOCLOPRAMIDE HYDROCHLORIDE NYSTATIN, NYSTATIN OXYBUTYNIN CHLORIDE, OXYBUTYNIN CHLORIDE OXYCODONE AND ACETAMINOPHEN, ACETAMINOPHEN OXYCODONE HYDROCHLORIDE, OXYCODONE HYDROCHLORIDE PERPHENAZINE, PERPHENAZINE PHENTERMINE HYDROCHLORIDE, PHENTERMINE HYDROCHLORIDE PREDNISONE, PREDNISONE PRIMIDONE, PRIMIDONE PROMETHAZINE HYDROCHLORIDE, PROMETHAZINE HYDROCHLORIDE PROPAFENONE HYDROCHLORIDE, PROPAFENONE HYDROCHLORIDE PROPOXYPHENE HYDROCHLORIDE AND ACETAMINOPHEN, ACETAMINOPHEN PROPOXYPHENE HYDROCHLORIDE, PROPOXYPHENE HYDROCHLORIDE PROPOXYPHENE NAPSYLATE AND ACETAMINOPHEN, ACETAMINOPHEN SOTALOL HYDROCHLORIDE, SOTALOL HYDROCHLORIDE SULFASALAZINE, SULFASALAZINE
TRIHEXYPHENIDYL HYDROCHLORIDE, TRIHEXYPHENIDYL HYDROCHLORIDE
VIROPHARMA * VIROPHARMA INC VANCOCIN HYDROCHLORIDE,

VANCOMYCIN HYDROCHLORIDE

VISTA PHARMS * VISTA PHARMACEUTICALS INC SULFAMETHOXAZOLE AND TRIMETHOPRIM, VISTAPHARM * VISTAPHARM INC ALBUTEROL SULFATE,

SULFAMETHOXAZOLE

ALBUTEROL SULFATE

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APPENDIX B

PRODUCT NAME SORTED BY APPLICANT


** V **

* VISTAPHARM INC LACTULOSE, LACTULOSE METHADONE HYDROCHLORIDE, METHADONE HYDROCHLORIDE METOCLOPRAMIDE HYDROCHLORIDE, METOCLOPRAMIDE HYDROCHLORIDE NYSTATIN, NYSTATIN
PHENYTOIN, PHENYTOIN
VIVUS * VIVUS INC MUSE, ALPROSTADIL WARNER CHILCOTT * WARNER CHILCOTT BERMUDA LTD CHOLEDYL SA, OXTRIPHYLLINE * WARNER CHILCOTT CO LLC ACTONEL, RISEDRONATE SODIUM
MACRODANTIN, NITROFURANTOIN, MACROCRYSTALLINE
* WARNER CHILCOTT INC ERYC, ERYTHROMYCIN ESTRACE, ESTRADIOL ESTROSTEP FE, ETHINYL ESTRADIOL FEMCON FE, ETHINYL ESTRADIOL FEMHRT, ETHINYL ESTRADIOL FEMTRACE, ESTRADIOL ACETATE LOESTRIN 21 1.5/30, ETHINYL ESTRADIOL LOESTRIN 21 1/20, ETHINYL ESTRADIOL LOESTRIN 24 FE, ETHINYL ESTRADIOL LOESTRIN FE 1.5/30, ETHINYL ESTRADIOL LOESTRIN FE 1/20, ETHINYL ESTRADIOL OVCON-35, ETHINYL ESTRADIOL OVCON-50, ETHINYL ESTRADIOL
SARAFEM, FLUOXETINE HYDROCHLORIDE
WARNER CHILCOTT INC * WARNER CHILCOTT PHARMACEUTICALS INC ASACOL HD, MESALAMINE
ASACOL, MESALAMINE
WATSON LABS * WATSON LABORATORIES ACETAMINOPHEN AND PENTAZOCINE HYDROCHLORIDE, ACETAMINOPHEN ALENDRONATE SODIUM, ALENDRONATE SODIUM ANAGRELIDE HYDROCHLORIDE, ANAGRELIDE HYDROCHLORIDE CARBOPLATIN, CARBOPLATIN CARVEDILOL, CARVEDILOL FOLIC ACID, FOLIC ACID LEVONORGESTREL AND ETHINYL ESTRADIOL, ETHINYL ESTRADIOL METFORMIN HYDROCHLORIDE, METFORMIN HYDROCHLORIDE MICROGESTIN 1.5/30, ETHINYL ESTRADIOL MICROGESTIN 1/20, ETHINYL ESTRADIOL MICROGESTIN FE 1.5/30, ETHINYL ESTRADIOL MICROGESTIN FE 1/20, ETHINYL ESTRADIOL NORCO, ACETAMINOPHEN NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL, ETHINYL ESTRADIOL OXAPROZIN, OXAPROZIN OXYCODONE AND ACETAMINOPHEN, ACETAMINOPHEN PROPAFENONE HYDROCHLORIDE, PROPAFENONE HYDROCHLORIDE
TRAMADOL HYDROCHLORIDE, TRAMADOL HYDROCHLORIDE
* WATSON LABORATORIES INC ACEBUTOLOL HYDROCHLORIDE, ACEBUTOLOL HYDROCHLORIDE ACETAMINOPHEN AND CODEINE PHOSPHATE, ACETAMINOPHEN ACETAZOLAMIDE, ACETAZOLAMIDE ACETOHEXAMIDE, ACETOHEXAMIDE ACYCLOVIR, ACYCLOVIR AFEDITAB CR, NIFEDIPINE ALBUTEROL SULFATE AND IPRATROPIUM BROMIDE, ALBUTEROL SULFATE
ALBUTEROL SULFATE, ALBUTEROL SULFATE

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APPENDIX B

PRODUCT NAME SORTED BY APPLICANT


** W **

* WATSON LABORATORIES INC ALLOPURINOL, ALLOPURINOL ALORA, ESTRADIOL AMLODIPINE BESYLATE, AMLODIPINE BESYLATE AMOXAPINE, AMOXAPINE ANDRODERM, TESTOSTERONE ATENOLOL AND CHLORTHALIDONE, ATENOLOL ATENOLOL, ATENOLOL BACLOFEN, BACLOFEN BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE, BISOPROLOL FUMARATE BREVICON 28-DAY, ETHINYL ESTRADIOL BUPROPION HYDROCHLORIDE, BUPROPION HYDROCHLORIDE BUSPIRONE HYDROCHLORIDE, BUSPIRONE HYDROCHLORIDE BUTALBITAL, ACETAMINOPHEN AND CAFFEINE, ACETAMINOPHEN BUTALBITAL, ASPIRIN, CAFFEINE, AND CODEINE PHOSPHATE, ASPIRIN CAPTOPRIL, CAPTOPRIL CARBOPLATIN, CARBOPLATIN CARISOPRODOL, CARISOPRODOL CHLORDIAZEPOXIDE HYDROCHLORIDE, CHLORDIAZEPOXIDE HYDROCHLORIDE CHLORPROPAMIDE, CHLORPROPAMIDE CHLORZOXAZONE, CHLORZOXAZONE CICLOPIROX, CICLOPIROX CIMETIDINE, CIMETIDINE CIMETIDINE, CIMETIDINE (OTC) CITALOPRAM HYDROBROMIDE, CITALOPRAM HYDROBROMIDE CLINDAMYCIN HYDROCHLORIDE, CLINDAMYCIN HYDROCHLORIDE CLONAZEPAM, CLONAZEPAM CLONIDINE HYDROCHLORIDE, CLONIDINE HYDROCHLORIDE CLORAZEPATE DIPOTASSIUM, CLORAZEPATE DIPOTASSIUM COL-PROBENECID, COLCHICINE CORDRAN, FLURANDRENOLIDE CYCLOBENZAPRINE HYDROCHLORIDE, CYCLOBENZAPRINE HYDROCHLORIDE CYCLOSPORINE, CYCLOSPORINE DEFEROXAMINE MESYLATE, DEFEROXAMINE MESYLATE DESMOPRESSIN ACETATE, DESMOPRESSIN ACETATE DESOGESTREL AND ETHINYL ESTRADIOL, DESOGESTREL DIAZEPAM, DIAZEPAM DICLOFENAC POTASSIUM, DICLOFENAC POTASSIUM DICYCLOMINE HYDROCHLORIDE, DICYCLOMINE HYDROCHLORIDE DILACOR XR, DILTIAZEM HYDROCHLORIDE DIMENHYDRINATE, DIMENHYDRINATE DIPHENHYDRAMINE HYDROCHLORIDE PRESERVATIVE FREE, DIPHENHYDRAMINE HYDROCHLORIDE DIPHENHYDRAMINE HYDROCHLORIDE, DIPHENHYDRAMINE HYDROCHLORIDE DIPYRIDAMOLE, DIPYRIDAMOLE DISOPYRAMIDE PHOSPHATE, DISOPYRAMIDE PHOSPHATE DOBUTAMINE HYDROCHLORIDE, DOBUTAMINE HYDROCHLORIDE DOXAPRAM HYDROCHLORIDE, DOXAPRAM HYDROCHLORIDE DOXAZOSIN MESYLATE, DOXAZOSIN MESYLATE DOXEPIN HYDROCHLORIDE, DOXEPIN HYDROCHLORIDE DOXYCYCLINE HYCLATE, DOXYCYCLINE HYCLATE DOXYCYCLINE, DOXYCYCLINE ENALAPRIL MALEATE, ENALAPRIL MALEATE EPIRUBICIN HYDROCHLORIDE, EPIRUBICIN HYDROCHLORIDE ERGOLOID MESYLATES, ERGOLOID MESYLATES ESTAZOLAM, ESTAZOLAM ESTRADIOL CYPIONATE, ESTRADIOL CYPIONATE ESTRADIOL VALERATE, ESTRADIOL VALERATE ESTRADIOL, ESTRADIOL ESTRONE, ESTRONE ESTROPIPATE, ESTROPIPATE FAMOTIDINE, FAMOTIDINE FAMOTIDINE, FAMOTIDINE (OTC) FENTANYL-100, FENTANYL FENTANYL-25, FENTANYL
FENTANYL-50, FENTANYL

SEPTEMBER 2010 - APPROVED DRUG PRODUCTS LIST

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APPENDIX B

PRODUCT NAME SORTED BY APPLICANT


** W **

* WATSON LABORATORIES INC FENTANYL-75, FENTANYL FLURAZEPAM HYDROCHLORIDE, FLURAZEPAM HYDROCHLORIDE FLUTAMIDE, FLUTAMIDE FOSINOPRIL SODIUM, FOSINOPRIL SODIUM FUROSEMIDE, FUROSEMIDE GABAPENTIN, GABAPENTIN GALANTAMINE HYDROBROMIDE, GALANTAMINE HYDROBROMIDE GELNIQUE, OXYBUTYNIN CHLORIDE GEMFIBROZIL, GEMFIBROZIL GLIPIZIDE, GLIPIZIDE GRANISETRON HYDROCHLORIDE, GRANISETRON HYDROCHLORIDE GUANFACINE HYDROCHLORIDE, GUANFACINE HYDROCHLORIDE HYDRALAZINE HYDROCHLORIDE, HYDRALAZINE HYDROCHLORIDE HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE HYDROCODONE BITARTRATE AND ACETAMINOPHEN, ACETAMINOPHEN HYDROXOCOBALAMIN, HYDROXOCOBALAMIN HYDROXYCHLOROQUINE SULFATE, HYDROXYCHLOROQUINE SULFATE HYDROXYZINE HYDROCHLORIDE, HYDROXYZINE HYDROCHLORIDE HYDROXYZINE PAMOATE, HYDROXYZINE PAMOATE IBUPROFEN, IBUPROFEN IBUPROFEN, IBUPROFEN (OTC) INDAPAMIDE, INDAPAMIDE IRINOTECAN HYDROCHLORIDE, IRINOTECAN HYDROCHLORIDE ISONIAZID, ISONIAZID ISOSORBIDE DINITRATE, ISOSORBIDE DINITRATE LABETALOL HYDROCHLORIDE, LABETALOL HYDROCHLORIDE LEVONORGESTREL AND ETHINYL ESTRADIOL, ETHINYL ESTRADIOL LEVONORGESTREL, LEVONORGESTREL LEVONORGESTREL, LEVONORGESTREL (OTC) LEVORA 0.15/30-28, ETHINYL ESTRADIOL LISINOPRIL, LISINOPRIL LORAZEPAM, LORAZEPAM LOW-OGESTREL-21, ETHINYL ESTRADIOL LOW-OGESTREL-28, ETHINYL ESTRADIOL LOXAPINE SUCCINATE, LOXAPINE SUCCINATE MECLIZINE HYDROCHLORIDE, MECLIZINE HYDROCHLORIDE MECLOFENAMATE SODIUM, MECLOFENAMATE SODIUM MELOXICAM, MELOXICAM MEPERIDINE HYDROCHLORIDE PRESERVATIVE FREE, MEPERIDINE HYDROCHLORIDE MEPERIDINE HYDROCHLORIDE, MEPERIDINE HYDROCHLORIDE MEPIVACAINE HYDROCHLORIDE, MEPIVACAINE HYDROCHLORIDE MEPROBAMATE, MEPROBAMATE METAPROTERENOL SULFATE, METAPROTERENOL SULFATE METHOCARBAMOL, METHOCARBAMOL METHYCLOTHIAZIDE, METHYCLOTHIAZIDE METHYLDOPA, METHYLDOPA METHYLPHENIDATE HYDROCHLORIDE, METHYLPHENIDATE HYDROCHLORIDE METHYLPREDNISOLONE, METHYLPREDNISOLONE METOCLOPRAMIDE HYDROCHLORIDE, METOCLOPRAMIDE HYDROCHLORIDE METOPROLOL TARTRATE, METOPROLOL TARTRATE METRONIDAZOLE, METRONIDAZOLE MEXILETINE HYDROCHLORIDE, MEXILETINE HYDROCHLORIDE MICROZIDE, HYDROCHLOROTHIAZIDE MINOCYCLINE HYDROCHLORIDE, MINOCYCLINE HYDROCHLORIDE MINOXIDIL, MINOXIDIL MIRTAZAPINE, MIRTAZAPINE MORPHINE SULFATE, MORPHINE SULFATE NAPROXEN SODIUM, NAPROXEN SODIUM NAPROXEN, NAPROXEN NEOMYCIN AND POLYMYXIN B SULFATE, NEOMYCIN SULFATE NICARDIPINE HYDROCHLORIDE, NICARDIPINE HYDROCHLORIDE NICOTINE POLACRILEX, NICOTINE POLACRILEX (OTC) NITROFURANTOIN, NITROFURANTOIN, MACROCRYSTALLINE
NIZATIDINE, NIZATIDINE

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APPENDIX B

PRODUCT NAME SORTED BY APPLICANT


** W **

* WATSON LABORATORIES INC NORCO, ACETAMINOPHEN NORETHIN 1/35E-21, ETHINYL ESTRADIOL NORETHIN 1/35E-28, ETHINYL ESTRADIOL NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE, ETHINYL ESTRADIOL NORETHINDRONE AND ETHINYL ESTRADIOL (10/11), ETHINYL ESTRADIOL NORETHINDRONE AND ETHINYL ESTRADIOL (7/14), ETHINYL ESTRADIOL NORETHINDRONE AND ETHINYL ESTRADIOL, ETHINYL ESTRADIOL NORGESTIMATE AND ETHINYL ESTRADIOL, ETHINYL ESTRADIOL NORINYL 1+35 21-DAY, ETHINYL ESTRADIOL NORINYL 1+35 28-DAY, ETHINYL ESTRADIOL NORINYL 1+50 28-DAY, MESTRANOL NORTRIPTYLINE HYDROCHLORIDE, NORTRIPTYLINE HYDROCHLORIDE OGESTREL 0.5/50-28, ETHINYL ESTRADIOL ORPHENADRINE CITRATE, ORPHENADRINE CITRATE OXAZEPAM, OXAZEPAM OXYCODONE AND ACETAMINOPHEN, ACETAMINOPHEN OXYCODONE AND ASPIRIN, ASPIRIN OXYCODONE HYDROCHLORIDE AND IBUPROFEN, IBUPROFEN PENTAMIDINE ISETHIONATE, PENTAMIDINE ISETHIONATE PENTAZOCINE AND NALOXONE HYDROCHLORIDES, NALOXONE HYDROCHLORIDE PENTOXIFYLLINE, PENTOXIFYLLINE PINDOLOL, PINDOLOL PIROXICAM, PIROXICAM PRAVASTATIN SODIUM, PRAVASTATIN SODIUM PREDNISOLONE, PREDNISOLONE PREDNISONE, PREDNISONE PRIMIDONE, PRIMIDONE PROBENECID, PROBENECID PROMETHAZINE HYDROCHLORIDE, PROMETHAZINE HYDROCHLORIDE PROPRANOLOL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE PROPRANOLOL HYDROCHLORIDE, PROPRANOLOL HYDROCHLORIDE QUASENSE, ETHINYL ESTRADIOL QUINIDINE GLUCONATE, QUINIDINE GLUCONATE QUINIDINE SULFATE, QUINIDINE SULFATE RANITIDINE HYDROCHLORIDE, RANITIDINE HYDROCHLORIDE RANITIDINE HYDROCHLORIDE, RANITIDINE HYDROCHLORIDE (OTC) RAPAFLO, SILODOSIN RIVASTIGMINE TARTRATE, RIVASTIGMINE TARTRATE SPIRONOLACTONE AND HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE SULFASALAZINE, SULFASALAZINE SULINDAC, SULINDAC TAMOXIFEN CITRATE, TAMOXIFEN CITRATE TEMAZEPAM, TEMAZEPAM TERBINAFINE HYDROCHLORIDE, TERBINAFINE HYDROCHLORIDE TESTOSTERONE CYPIONATE, TESTOSTERONE CYPIONATE TESTOSTERONE ENANTHATE, TESTOSTERONE ENANTHATE TETRACYCLINE HYDROCHLORIDE, TETRACYCLINE HYDROCHLORIDE THIAMINE HYDROCHLORIDE, THIAMINE HYDROCHLORIDE THIOTHIXENE, THIOTHIXENE TOLAZAMIDE, TOLAZAMIDE TOLBUTAMIDE, TOLBUTAMIDE TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN, ACETAMINOPHEN TRAZODONE HYDROCHLORIDE, TRAZODONE HYDROCHLORIDE TRELSTAR DEPOT, TRIPTORELIN PAMOATE TRELSTAR LA, TRIPTORELIN PAMOATE TRELSTAR, TRIPTORELIN PAMOATE TRIAMTERENE AND HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE TRIAZOLAM, TRIAZOLAM TRIHEXYPHENIDYL HYDROCHLORIDE, TRIHEXYPHENIDYL HYDROCHLORIDE TRIMETHOPRIM, TRIMETHOPRIM TRI-NORINYL 28-DAY, ETHINYL ESTRADIOL TRIVORA-28, ETHINYL ESTRADIOL VECURONIUM BROMIDE, VECURONIUM BROMIDE
VERAPAMIL HYDROCHLORIDE, VERAPAMIL HYDROCHLORIDE

SEPTEMBER 2010 - APPROVED DRUG PRODUCTS LIST

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APPENDIX B

PRODUCT NAME SORTED BY APPLICANT


** W **

* WATSON LABORATORIES INC ZOLPIDEM TARTRATE, ZOLPIDEM TARTRATE ZOVIA 1/35E-28, ETHINYL ESTRADIOL
ZOVIA 1/50E-28, ETHINYL ESTRADIOL
* WATSON LABS INC LISINOPRIL AND HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE WATSON LABS (UTAH) * WATSON LABORATORIES INC INFED, IRON DEXTRAN NOR-QD, NORETHINDRONE OXYTROL, OXYBUTYNIN
PROGESTERONE, PROGESTERONE
WATSON LABS FLORIDA * WATSON LABORATORIES INC FLORIDA ACETAMINOPHEN AND CODEINE PHOSPHATE, ACETAMINOPHEN BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE, BENAZEPRIL HYDROCHLORIDE BENAZEPRIL HYDROCHLORIDE, BENAZEPRIL HYDROCHLORIDE CARTIA XT, DILTIAZEM HYDROCHLORIDE CLARITHROMYCIN, CLARITHROMYCIN DILTIAZEM HYDROCHLORIDE, DILTIAZEM HYDROCHLORIDE FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE, FOSINOPRIL SODIUM FOSINOPRIL SODIUM, FOSINOPRIL SODIUM HYDROCODONE BITARTRATE AND ACETAMINOPHEN, ACETAMINOPHEN HYDROCODONE BITARTRATE AND IBUPROFEN, HYDROCODONE BITARTRATE KETOPROFEN, KETOPROFEN LORATADINE AND PSEUDOEPHEDRINE SULFATE, LORATADINE (OTC) LORATADINE, LORATADINE (OTC) METFORMIN HYDROCHLORIDE, METFORMIN HYDROCHLORIDE METOPROLOL SUCCINATE, METOPROLOL SUCCINATE MIRTAZAPINE, MIRTAZAPINE OMEPRAZOLE, OMEPRAZOLE POTASSIUM CHLORIDE, POTASSIUM CHLORIDE QUINAPRIL HYDROCHLORIDE, QUINAPRIL HYDROCHLORIDE TAMOXIFEN CITRATE, TAMOXIFEN CITRATE
TAZTIA XT, DILTIAZEM HYDROCHLORIDE
WATSON PHARMS * WATSON PHARMACEUTICALS TENUATE DOSPAN, DIETHYLPROPION HYDROCHLORIDE
TENUATE, DIETHYLPROPION HYDROCHLORIDE
* WATSON PHARMACEUTICALS INC ACTIGALL, URSODIOL CONDYLOX, PODOFILOX CORDRAN SP, FLURANDRENOLIDE CORDRAN, FLURANDRENOLIDE FIORICET W/ CODEINE, ACETAMINOPHEN FIORICET, ACETAMINOPHEN FIORINAL W/CODEINE, ASPIRIN FIORINAL, ASPIRIN
MONODOX, DOXYCYCLINE
WE PHARMS * WE PHARMACEUTICALS INC PREDNISOLONE SODIUM PHOSPHATE,

PREDNISOLONE SODIUM PHOSPHATE

WEILL MEDCL COLL * WEILL MEDICAL COLLEGE CORNELL UNIV FLUDEOXYGLUCOSE F 18, FLUDEOXYGLUCOSE F-18 WELLSPRING PHARM * WELLSPRING PHARMACEUTICAL CORP DIBENZYLINE, PHENOXYBENZAMINE HYDROCHLORIDE DUVOID, BETHANECHOL CHLORIDE
DYRENIUM, TRIAMTERENE

SEPTEMBER 2010 - APPROVED DRUG PRODUCTS LIST

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APPENDIX B

PRODUCT NAME SORTED BY APPLICANT


** W **

WEST WARD * WEST WARD INC ERGOTAMINE TARTRATE AND CAFFEINE, CAFFEINE
ISOSORBIDE DINITRATE, ISOSORBIDE DINITRATE
* WEST WARD PHARMACEUTICAL CORP ACETAMINOPHEN, CAFFEINE, AND DIHYDROCODEINE BITARTRATE, ACETAMINOPHEN AMINOPHYLLINE, AMINOPHYLLINE BUTALBITAL, ACETAMINOPHEN AND CAFFEINE, ACETAMINOPHEN BUTALBITAL, ACETAMINOPHEN, CAFFEINE AND CODEINE PHOSPHATE, ACETAMINOPHEN BUTALBITAL, ASPIRIN AND CAFFEINE, ASPIRIN CAPTOPRIL, CAPTOPRIL CARISOPRODOL, CARISOPRODOL CHLOROQUINE PHOSPHATE, CHLOROQUINE PHOSPHATE CHLOROTHIAZIDE, CHLOROTHIAZIDE CIPROFLOXACIN, CIPROFLOXACIN CORTISONE ACETATE, CORTISONE ACETATE DICYCLOMINE HYDROCHLORIDE, DICYCLOMINE HYDROCHLORIDE DIGOXIN, DIGOXIN DOXYCYCLINE HYCLATE, DOXYCYCLINE HYCLATE ETHAMBUTOL HYDROCHLORIDE, ETHAMBUTOL HYDROCHLORIDE FLURAZEPAM HYDROCHLORIDE, FLURAZEPAM HYDROCHLORIDE FOLIC ACID, FOLIC ACID GLYCOPYRROLATE, GLYCOPYRROLATE HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE HYDROCORTISONE, HYDROCORTISONE HYDROXYCHLOROQUINE SULFATE, HYDROXYCHLOROQUINE SULFATE ISONIAZID, ISONIAZID ISOSORBIDE DINITRATE, ISOSORBIDE DINITRATE ISOSORBIDE MONONITRATE, ISOSORBIDE MONONITRATE LISINOPRIL AND HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE LISINOPRIL, LISINOPRIL LITHIUM CARBONATE, LITHIUM CARBONATE METHOCARBAMOL, METHOCARBAMOL ONDANSETRON HYDROCHLORIDE, ONDANSETRON HYDROCHLORIDE PREDNISONE, PREDNISONE PRIMIDONE, PRIMIDONE PROPOXYPHENE HYDROCHLORIDE, PROPOXYPHENE HYDROCHLORIDE PROPYLTHIOURACIL, PROPYLTHIOURACIL TRIHEXYPHENIDYL HYDROCHLORIDE, TRIHEXYPHENIDYL HYDROCHLORIDE
ZALEPLON, ZALEPLON
WEST WARD PHARMS * WEST WARD PHARMACEUTICALS CORP RISPERIDONE, RISPERIDONE WESTWARD * WESTWARD PHARMACEUTICAL CORP NAPROXEN, NAPROXEN
RIFAMPIN AND ISONIAZID, ISONIAZID
WOCKHARDT * WOCKHARDT AMERICAS INC CAPTOPRIL, CAPTOPRIL ENALAPRIL MALEATE, ENALAPRIL MALEATE FAMOTIDINE, FAMOTIDINE
RANITIDINE HYDROCHLORIDE, RANITIDINE HYDROCHLORIDE
* WOCKHARDT EU OPERATIONS (SWISS) AG LEVETIRACETAM, LEVETIRACETAM
PHENYTOIN, PHENYTOIN
* WOCKHARDT LTD ADENOSINE, ADENOSINE AMIODARONE HYDROCHLORIDE, AMIODARONE HYDROCHLORIDE AMLODIPINE BESYLATE, AMLODIPINE BESYLATE AZITHROMYCIN, AZITHROMYCIN BETAXOLOL HYDROCHLORIDE, BETAXOLOL HYDROCHLORIDE
BETHANECHOL CHLORIDE, BETHANECHOL CHLORIDE

SEPTEMBER 2010 - APPROVED DRUG PRODUCTS LIST

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APPENDIX B

PRODUCT NAME SORTED BY APPLICANT


** W **

* WOCKHARDT LTD CARVEDILOL, CARVEDILOL CEFOTAXIME SODIUM, CEFOTAXIME SODIUM CEFOTAXIME, CEFOTAXIME SODIUM CEFPROZIL, CEFPROZIL CEFTAZIDIME, CEFTAZIDIME CEFTRIAXONE, CEFTRIAXONE SODIUM CEFUROXIME AXETIL, CEFUROXIME AXETIL CETIRIZINE HYDROCHLORIDE ALLERGY, CETIRIZINE HYDROCHLORIDE (OTC) CETIRIZINE HYDROCHLORIDE, CETIRIZINE HYDROCHLORIDE CLARITHROMYCIN, CLARITHROMYCIN DIVALPROEX SODIUM, DIVALPROEX SODIUM EXTENDED PHENYTOIN SODIUM, PHENYTOIN SODIUM FAMOTIDINE, FAMOTIDINE (OTC) FLUOXETINE HYDROCHLORIDE, FLUOXETINE HYDROCHLORIDE FOSPHENYTOIN SODIUM, FOSPHENYTOIN SODIUM FUROSEMIDE, FUROSEMIDE KETOROLAC TROMETHAMINE, KETOROLAC TROMETHAMINE LAMOTRIGINE, LAMOTRIGINE LEVETIRACETAM, LEVETIRACETAM LISINOPRIL, LISINOPRIL MIDAZOLAM HYDROCHLORIDE, MIDAZOLAM HYDROCHLORIDE NIACIN, NIACIN NICARDIPINE HYDROCHLORIDE, NICARDIPINE HYDROCHLORIDE ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE, ONDANSETRON HYDROCHLORIDE ONDANSETRON HYDROCHLORIDE, ONDANSETRON HYDROCHLORIDE PROMETHAZINE HYDROCHLORIDE, PROMETHAZINE HYDROCHLORIDE PROPOXYPHENE NAPSYLATE AND ACETAMINOPHEN, ACETAMINOPHEN RANITIDINE HYDROCHLORIDE, RANITIDINE HYDROCHLORIDE RANITIDINE HYDROCHLORIDE, RANITIDINE HYDROCHLORIDE (OTC) RISPERIDONE, RISPERIDONE ROPINIROLE HYDROCHLORIDE, ROPINIROLE HYDROCHLORIDE SERTRALINE HYDROCHLORIDE, SERTRALINE HYDROCHLORIDE SUMATRIPTAN SUCCINATE, SUMATRIPTAN SUCCINATE TERBINAFINE HYDROCHLORIDE, TERBINAFINE HYDROCHLORIDE TIMOLOL MALEATE, TIMOLOL MALEATE ZOLPIDEM TARTRATE, ZOLPIDEM TARTRATE
ZONISAMIDE, ZONISAMIDE
WOCKHARDT USA * WOCKHARDT USA INC EXTENDED PHENYTOIN SODIUM, GRANISETRON HYDROCHLORIDE, WORLD GEN * WORLD GEN LLC AMLODIPINE BESYLATE, CEFACLOR, CEFACLOR

PHENYTOIN SODIUM
GRANISETRON HYDROCHLORIDE

AMLODIPINE BESYLATE

WRASER PHARMS * WRASER PHARMACEUTICALS LLC CETRAXAL, CIPROFLOXACIN HYDROCHLORIDE WYETH CONS * WYETH CONSUMER HEALTHCARE ADVIL ALLERGY SINUS, CHLORPHENIRAMINE MALEATE (OTC) ADVIL COLD AND SINUS, IBUPROFEN (OTC) ADVIL LIQUI-GELS, IBUPROFEN (OTC) ADVIL MIGRAINE LIQUI-GELS, IBUPROFEN (OTC) ADVIL PM, DIPHENHYDRAMINE CITRATE (OTC) ADVIL PM, DIPHENHYDRAMINE HYDROCHLORIDE (OTC) ADVIL, IBUPROFEN (OTC) ALAVERT, LORATADINE (OTC) AXID AR, NIZATIDINE (OTC) CHILDREN'S ADVIL ALLERGY SINUS, CHLORPHENIRAMINE MALEATE CHILDREN'S ADVIL COLD, IBUPROFEN (OTC)
CHILDREN'S ADVIL, IBUPROFEN (OTC)

(OTC)

SEPTEMBER 2010 - APPROVED DRUG PRODUCTS LIST

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APPENDIX B

PRODUCT NAME SORTED BY APPLICANT

** W **

* WYETH CONSUMER HEALTHCARE CHILDREN'S ADVIL-FLAVORED, IBUPROFEN (OTC) JUNIOR STRENGTH ADVIL, IBUPROFEN (OTC) LORATADINE, LORATADINE (OTC)
PEDIATRIC ADVIL, IBUPROFEN (OTC)
WYETH PHARMS INC * WYETH PHARMACEUTICALS INC CORDARONE, AMIODARONE HYDROCHLORIDE EFFEXOR XR, VENLAFAXINE HYDROCHLORIDE EFFEXOR, VENLAFAXINE HYDROCHLORIDE LYBREL, ETHINYL ESTRADIOL MYLOTARG, GEMTUZUMAB OZOGAMICIN PHOSPHOLINE IODIDE, ECHOTHIOPHATE IODIDE PREMARIN, ESTROGENS, CONJUGATED PREMPHASE 14/14, ESTROGENS, CONJUGATED PREMPRO, ESTROGENS, CONJUGATED PRISTIQ, DESVENLAFAXINE SUCCINATE PROTONIX IV, PANTOPRAZOLE SODIUM PROTONIX, PANTOPRAZOLE SODIUM RAPAMUNE, SIROLIMUS TORISEL, TEMSIROLIMUS TRECATOR, ETHIONAMIDE TYGACIL, TIGECYCLINE ZOSYN IN PLASTIC CONTAINER, PIPERACILLIN SODIUM ZOSYN, PIPERACILLIN SODIUM X GEN PHARMS * X GEN PHARMACEUTICALS INC ACETAZOLAMIDE SODIUM, ACETAZOLAMIDE SODIUM AMPHOTERICIN B, AMPHOTERICIN B BACIIM, BACITRACIN BACI-RX, BACITRACIN COLISTIMETHATE SODIUM, COLISTIMETHATE SODIUM EPIRUBICIN HYDROCHLORIDE, EPIRUBICIN HYDROCHLORIDE HYDROCORTISONE ACETATE, HYDROCORTISONE ACETATE HYDRO-RX, HYDROCORTISONE LIOTHYRONINE SODIUM, LIOTHYRONINE SODIUM NEO-FRADIN, NEOMYCIN SULFATE NEOMYCIN AND POLYMYXIN B SULFATE, NEOMYCIN SULFATE NEOMYCIN SULFATE, NEOMYCIN SULFATE NEO-RX, NEOMYCIN SULFATE NYSTATIN, NYSTATIN POLYMYXIN B SULFATE, POLYMYXIN B SULFATE POLY-RX, POLYMYXIN B SULFATE STREPTOMYCIN SULFATE, STREPTOMYCIN SULFATE TOBRAMYCIN SULFATE, TOBRAMYCIN SULFATE XANODYNE PHARM * XANODYNE PHARMACEUTICS INC AMICAR, AMINOCAPROIC ACID DARVOCET A500, ACETAMINOPHEN DARVOCET-N 100, ACETAMINOPHEN DARVOCET-N 50, ACETAMINOPHEN DARVON, PROPOXYPHENE HYDROCHLORIDE DARVON-N, PROPOXYPHENE NAPSYLATE LYSTEDA, TRANEXAMIC ACID ORAMORPH SR, MORPHINE SULFATE
ZIPSOR, DICLOFENAC POTASSIUM
XANODYNE PHARMS * XANODYNE PHARMACEUTICALS INC ROXICODONE, OXYCODONE HYDROCHLORIDE XTTRIUM * XTTRIUM LABORATORIES INC CHLORHEXIDINE GLUCONATE, CHLORHEXIDINE GLUCONATE DYNA-HEX, CHLORHEXIDINE GLUCONATE (OTC)

SEPTEMBER 2010 - APPROVED DRUG PRODUCTS LIST

B - 136

APPENDIX B

PRODUCT NAME SORTED BY APPLICANT


** X **
(OTC)

* XTTRIUM LABORATORIES INC EXIDINE, CHLORHEXIDINE GLUCONATE

YUNG SHIN PHARM * YUNG SHIN PHARMACEUTICAL INDUSTRIAL CO LTD CEFACLOR, CEFACLOR
CEPHALEXIN, CEPHALEXIN
ZAMBON SPA * ZAMBON SPA ITALY MONUROL, FOSFOMYCIN TROMETHAMINE ZARS PHARM * ZARS PHARMA INC SYNERA, LIDOCAINE ZOGENIX INC * ZOGENIX INC SUMAVEL DOSEPRO,

SUMATRIPTAN SUCCINATE

ZYDUS PHARMS USA * ZYDUS PHARMACEUTICALS USA INC AMLODIPINE BESYLATE, AMLODIPINE BESYLATE ATENOLOL, ATENOLOL AZATHIOPRINE, AZATHIOPRINE BENAZEPRIL HYDROCHLORIDE, BENAZEPRIL HYDROCHLORIDE BENZONATATE, BENZONATATE CLINDAMYCIN HYDROCHLORIDE, CLINDAMYCIN HYDROCHLORIDE HALOPERIDOL, HALOPERIDOL HYDRALAZINE HYDROCHLORIDE, HYDRALAZINE HYDROCHLORIDE LAMOTRIGINE, LAMOTRIGINE MELOXICAM, MELOXICAM METFORMIN HYDROCHLORIDE, METFORMIN HYDROCHLORIDE NAPROXEN, NAPROXEN PAROXETINE HYDROCHLORIDE, PAROXETINE HYDROCHLORIDE PRAVASTATIN SODIUM, PRAVASTATIN SODIUM PROMETHAZINE HYDROCHLORIDE, PROMETHAZINE HYDROCHLORIDE RAMIPRIL, RAMIPRIL RIBAVIRIN, RIBAVIRIN RISPERIDONE, RISPERIDONE SERTRALINE HYDROCHLORIDE, SERTRALINE HYDROCHLORIDE SIMVASTATIN, SIMVASTATIN VENLAFAXINE HYDROCHLORIDE, VENLAFAXINE HYDROCHLORIDE WARFARIN SODIUM, WARFARIN SODIUM
ZONISAMIDE, ZONISAMIDE
ZYDUS PHARMS USA INC * ZYDUS PHARMACEUTICALS USA INC ACETAZOLAMIDE, ACETAZOLAMIDE ALPRAZOLAM, ALPRAZOLAM AMIODARONE HYDROCHLORIDE, AMIODARONE HYDROCHLORIDE BICALUTAMIDE, BICALUTAMIDE BROMOCRIPTINE MESYLATE, BROMOCRIPTINE MESYLATE CARVEDILOL, CARVEDILOL DIPYRIDAMOLE, DIPYRIDAMOLE DIVALPROEX SODIUM, DIVALPROEX SODIUM FINASTERIDE, FINASTERIDE HYDROXYCHLOROQUINE SULFATE, HYDROXYCHLOROQUINE SULFATE LAMOTRIGINE, LAMOTRIGINE LEVETIRACETAM, LEVETIRACETAM MYCOPHENOLATE MOFETIL, MYCOPHENOLATE MOFETIL RAMIPRIL, RAMIPRIL RISPERIDONE, RISPERIDONE ROPINIROLE HYDROCHLORIDE, ROPINIROLE HYDROCHLORIDE
TOPIRAMATE, TOPIRAMATE

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