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DECEMBER 2013 - APPROVED DRUG PRODUCT LIST APPENDIX B - PRODUCT NAME SORTED BY APPLICANT ** 3 ** ** A ** 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 PHARMACEUTICAL PRODUCTS DIV HYTRIN, TERAZOSIN HYDROCHLORIDE ABBVIE * ABBVIE INC ANDROGEL, TESTOSTERONE CREON, PANCRELIPASE (AMYLASE CYCLOSPORINE, CYCLOSPORINE K-TAB, POTASSIUM CHLORIDE NIASPAN, NIACIN TRILIPIX, CHOLINE FENOFIBRATE ZEMPLAR, PARICALCITOL ABBVIE ENDOCRINE * ABBVIE ENDOCRINE INC LUPANETA PACK, LEUPROLIDE ACETATE ABBVIE ENDOCRINE INC * ABBVIE ENDOCRINE INC LUPRON DEPOT, LEUPROLIDE ACETATE LUPRON DEPOT-PED, LEUPROLIDE ACETATE ABBVIE INC * ABBVIE INC PROMETRIUM, PROGESTERONE ABRAXIS BIOSCIENCE * ABRAXIS BIOSCIENCE LLC ABRAXANE, PACLITAXEL ABRAXIS PHARM * ABRAXIS PHARMACEUTICAL PRODUCTS CLINDAMYCIN PHOSPHATE IN DEXTROSE 5%, CLINDAMYCIN PHOSPHATE ACADEMIC PHARMS * ACADEMIC PHARMACEUTICALS INC SOTALOL HYDROCHLORIDE, SOTALOL HYDROCHLORIDE ACCELRX LABS * ACCELRX LABS LLC CARISOPRODOL, CARISOPRODOL ACCORD HLTHCARE * ACCORD HEALTHCARE INC ALLOPURINOL, ALLOPURINOL AMLODIPINE BESYLATE, AMLODIPINE BESYLATE ANASTROZOLE, ANASTROZOLE BICALUTAMIDE, BICALUTAMIDE CARBIDOPA AND LEVODOPA, CARBIDOPA CLONAZEPAM, CLONAZEPAM CLOPIDOGREL BISULFATE, CLOPIDOGREL BISULFATE DOCETAXEL, DOCETAXEL ESCITALOPRAM OXALATE, ESCITALOPRAM OXALATE ETOPOSIDE, ETOPOSIDE FINASTERIDE, FINASTERIDE FLUOROURACIL, FLUOROURACIL GEMCITABINE HYDROCHLORIDE, GEMCITABINE HYDROCHLORIDE GLIMEPIRIDE, GLIMEPIRIDE GLIPIZIDE, GLIPIZIDE B - 1 DECEMBER 2013 - APPROVED DRUG PRODUCT LIST APPENDIX B - B - 2 PRODUCT NAME SORTED BY APPLICANT ** A ** * ACCORD HEALTHCARE INC HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE IRINOTECAN HYDROCHLORIDE, IRINOTECAN HYDROCHLORIDE LETROZOLE, LETROZOLE LEVETIRACETAM, LEVETIRACETAM LISINOPRIL, LISINOPRIL METHOTREXATE SODIUM PRESERVATIVE FREE, METHOTREXATE SODIUM METHYLDOPA, METHYLDOPA MITOMYCIN, MITOMYCIN MONTELUKAST SODIUM, MONTELUKAST SODIUM MYCOPHENOLATE MOFETIL, MYCOPHENOLATE MOFETIL NALTREXONE HYDROCHLORIDE, NALTREXONE HYDROCHLORIDE PIOGLITAZONE HYDROCHLORIDE, PIOGLITAZONE HYDROCHLORIDE QUETIAPINE FUMARATE, QUETIAPINE FUMARATE SIMVASTATIN, SIMVASTATIN TACROLIMUS, TACROLIMUS TOPIRAMATE, TOPIRAMATE TOPOTECAN HYDROCHLORIDE, TOPOTECAN HYDROCHLORIDE ACCORD HLTHCARE INC * ACCORD HEALTHCARE INC USA FINASTERIDE, FINASTERIDE TRAMADOL HYDROCHLORIDE, TRAMADOL HYDROCHLORIDE ACELLA PHARMS LLC * ACELLA PHARMACEUTICALS LLC GABAPENTIN, GABAPENTIN ACORDA * ACORDA THERAPEUTICS INC AMPYRA, DALFAMPRIDINE QUTENZA, CAPSAICIN 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 IMIPENEM AND CILASTATIN, CILASTATIN SODIUM KEFZOL, CEFAZOLIN SODIUM MEROPENEM, MEROPENEM 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 LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER, LEVOFLOXACIN ZOLEDRONIC ACID, ZOLEDRONIC ACID ACS DOBFAR SPA * ACS DOBFAR SPA AMPICILLIN SODIUM, AMPICILLIN SODIUM ACTAVIS * ACTAVIS SOUTHATLANTIC LLC BUPROPION HYDROCHLORIDE, BUPROPION HYDROCHLORIDE ACTAVIS ELIZABETH * ACTAVIS ELIZABETH LLC ALPRAZOLAM, ALPRAZOLAM BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE, BUPRENORPHINE HYDROCHLORIDE CARBIDOPA AND LEVODOPA, CARBIDOPA CLONAZEPAM, CLONAZEPAM CLONIDINE HYDROCHLORIDE, CLONIDINE HYDROCHLORIDE DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE, AMPHETAMINE DEXTROAMPHETAMINE SULFATE, DEXTROAMPHETAMINE SULFATE DICLOFENAC SODIUM, DICLOFENAC SODIUM DOXEPIN HYDROCHLORIDE, DOXEPIN HYDROCHLORIDE DOXYCYCLINE HYCLATE, DOXYCYCLINE HYCLATE DECEMBER 2013 - APPROVED DRUG PRODUCT LIST APPENDIX B - PRODUCT NAME SORTED BY APPLICANT ** A ** * ACTAVIS ELIZABETH LLC DULOXETINE HYDROCHLORIDE, DULOXETINE HYDROCHLORIDE FLUVOXAMINE MALEATE, FLUVOXAMINE MALEATE GABAPENTIN, GABAPENTIN GLYBURIDE AND METFORMIN HYDROCHLORIDE, GLYBURIDE GUANFACINE HYDROCHLORIDE, GUANFACINE HYDROCHLORIDE HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE INDAPAMIDE, INDAPAMIDE ISOSORBIDE MONONITRATE, ISOSORBIDE MONONITRATE LAMOTRIGINE, LAMOTRIGINE LEVETIRACETAM, LEVETIRACETAM LOVASTATIN, LOVASTATIN MORPHINE SULFATE, MORPHINE SULFATE NIFEDIPINE, NIFEDIPINE OXAZEPAM, OXAZEPAM OXYCODONE AND ACETAMINOPHEN, ACETAMINOPHEN OXYCODONE HYDROCHLORIDE AND IBUPROFEN, IBUPROFEN OXYMORPHONE HYDROCHLORIDE, OXYMORPHONE HYDROCHLORIDE PROPRANOLOL HYDROCHLORIDE, PROPRANOLOL HYDROCHLORIDE PROPYLTHIOURACIL, PROPYLTHIOURACIL ROPINIROLE HYDROCHLORIDE, ROPINIROLE HYDROCHLORIDE SPIRONOLACTONE, SPIRONOLACTONE TEMAZEPAM, TEMAZEPAM TRAMADOL HYDROCHLORIDE, TRAMADOL HYDROCHLORIDE ZOLPIDEM TARTRATE, ZOLPIDEM TARTRATE ACTAVIS GRP PTC * ACTAVIS GROUP PTC EHF HYDRALAZINE HYDROCHLORIDE, HYDRALAZINE HYDROCHLORIDE PRAMIPEXOLE DIHYDROCHLORIDE, PRAMIPEXOLE DIHYDROCHLORIDE QUETIAPINE FUMARATE, QUETIAPINE FUMARATE SILDENAFIL CITRATE, SILDENAFIL CITRATE VALACYCLOVIR HYDROCHLORIDE, VALACYCLOVIR HYDROCHLORIDE ACTAVIS INC * ACTAVIS INC DILTIAZEM HYDROCHLORIDE, DILTIAZEM HYDROCHLORIDE DOCETAXEL, DOCETAXEL ZOLEDRONIC ACID, ZOLEDRONIC ACID ACTAVIS MID ATLANTIC * ACTAVIS MID ATLANTIC LLC ACETASOL HC, ACETIC ACID, GLACIAL ACYCLOVIR, ACYCLOVIR ALBUTEROL SULFATE, ALBUTEROL SULFATE BETAMETHASONE DIPROPIONATE, BETAMETHASONE DIPROPIONATE BETAMETHASONE VALERATE, BETAMETHASONE VALERATE CICLOPIROX, CICLOPIROX CLOBETASOL PROPIONATE, CLOBETASOL PROPIONATE CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE, BETAMETHASONE DIPROPIONATE CLOTRIMAZOLE, CLOTRIMAZOLE (OTC) CONSTULOSE, LACTULOSE ENULOSE, LACTULOSE FEXOFENADINE HYDROCHLORIDE, FEXOFENADINE HYDROCHLORIDE FLUOCINONIDE, FLUOCINONIDE GRISEOFULVIN, GRISEOFULVIN, MICROSIZE HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE, HOMATROPINE METHYLBROMIDE HYDROCORTISONE, HYDROCORTISONE IBUPROFEN, IBUPROFEN IBUPROFEN, IBUPROFEN (OTC) LEVETIRACETAM, LEVETIRACETAM M-ZOLE 3 COMBINATION PACK, MICONAZOLE NITRATE (OTC) 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) NYSTATIN, NYSTATIN B - 3 DECEMBER 2013 - APPROVED DRUG PRODUCT LIST APPENDIX B - PRODUCT NAME SORTED BY APPLICANT ** A ** * ACTAVIS MID ATLANTIC LLC 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 RANITIDINE HYDROCHLORIDE, RANITIDINE HYDROCHLORIDE VALNAC, BETAMETHASONE VALERATE ACTAVIS TOTOWA * ACTAVIS TOTOWA LLC BICALUTAMIDE, BICALUTAMIDE CARBOPLATIN, CARBOPLATIN CLOPIDOGREL BISULFATE, CLOPIDOGREL BISULFATE DESIPRAMINE HYDROCHLORIDE, DESIPRAMINE HYDROCHLORIDE EPIRUBICIN HYDROCHLORIDE, EPIRUBICIN HYDROCHLORIDE FINASTERIDE, FINASTERIDE FLUDARABINE PHOSPHATE, FLUDARABINE PHOSPHATE GEMCITABINE HYDROCHLORIDE, GEMCITABINE HYDROCHLORIDE IRINOTECAN HYDROCHLORIDE, IRINOTECAN HYDROCHLORIDE LAMOTRIGINE, LAMOTRIGINE LETROZOLE, LETROZOLE OXALIPLATIN, OXALIPLATIN OXYCODONE AND ACETAMINOPHEN, ACETAMINOPHEN PACLITAXEL, PACLITAXEL PANTOPRAZOLE SODIUM, PANTOPRAZOLE SODIUM TOPOTECAN HYDROCHLORIDE, TOPOTECAN HYDROCHLORIDE VINORELBINE TARTRATE, VINORELBINE TARTRATE ACTELION PHARMS LTD * ACTELION PHARMACEUTICALS LTD OPSUMIT, MACITENTAN TRACLEER, BOSENTAN VALCHLOR, MECHLORETHAMINE HYDROCHLORIDE VELETRI, EPOPROSTENOL SODIUM VENTAVIS, ILOPROST ZAVESCA, MIGLUSTAT ACTIENT PHARMS * ACTIENT PHARMACEUTICALS LLC DILATRATE-SR, ISOSORBIDE DINITRATE EDEX, ALPROSTADIL LEVATOL, PENBUTOLOL SULFATE ROBAXIN, METHOCARBAMOL ROBAXIN-750, METHOCARBAMOL SEMPREX-D, ACRIVASTINE STRIANT, TESTOSTERONE TESTOPEL, TESTOSTERONE THEO-24, THEOPHYLLINE ACTIVIS TOTOWA LLC * ACTIVIS TOTOWA LLC TOPIRAMATE, TOPIRAMATE ACTON PHARMS * ACTON PHARMACEUTICALS INC AEROSPAN HFA, FLUNISOLIDE AEGERION * AEGERION PHARMACEUTICALS INC JUXTAPID, LOMITAPIDE MESYLATE AGILA SPECLTS * AGILA SPECIALTIES PRIVATE LTD DEXAMETHASONE SODIUM PHOSPHATE, DEXAMETHASONE SODIUM PHOSPHATE DOXYCYCLINE, DOXYCYCLINE HYCLATE FAMOTIDINE PRESERVATIVE FREE, FAMOTIDINE FAMOTIDINE, FAMOTIDINE FLUMAZENIL, FLUMAZENIL HALOPERIDOL, HALOPERIDOL LACTATE KETOROLAC TROMETHAMINE, KETOROLAC TROMETHAMINE B - 4 DECEMBER 2013 - APPROVED DRUG PRODUCT LIST APPENDIX B - B - 5 PRODUCT NAME SORTED BY APPLICANT ** A ** * AGILA SPECIALTIES PRIVATE LTD LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE, LIDOCAINE HYDROCHLORIDE LIDOCAINE HYDROCHLORIDE, LIDOCAINE HYDROCHLORIDE ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE, ONDANSETRON HYDROCHLORIDE ONDANSETRON HYDROCHLORIDE, ONDANSETRON HYDROCHLORIDE PAMIDRONATE DISODIUM, PAMIDRONATE DISODIUM RIFAMPIN, RIFAMPIN TOBRAMYCIN SULFATE, TOBRAMYCIN SULFATE VANCOMYCIN HYDROCHLORIDE, VANCOMYCIN HYDROCHLORIDE VECURONIUM BROMIDE, VECURONIUM BROMIDE ZOLEDRONIC ACID, ZOLEDRONIC ACID AGOURON * AGOURON PHARMACEUTICALS INC VIRACEPT, NELFINAVIR MESYLATE AJANTA PHARMA * AJANTA PHARMA LTD LEVETIRACETAM, LEVETIRACETAM AJANTA PHARMA LTD * AJANTA PHARMA LTD RISPERIDONE, RISPERIDONE AKORN * AKORN INC ADENOSINE, ADENOSINE AK-FLUOR 10%, FLUORESCEIN SODIUM AK-FLUOR 25%, FLUORESCEIN SODIUM AKTEN, LIDOCAINE HYDROCHLORIDE ALFENTA, ALFENTANIL HYDROCHLORIDE AMIODARONE HYDROCHLORIDE, AMIODARONE HYDROCHLORIDE BACITRACIN, BACITRACIN BALANCED SALT, CALCIUM CHLORIDE BETAXOLOL HYDROCHLORIDE, BETAXOLOL HYDROCHLORIDE BRIMONIDINE TARTRATE, BRIMONIDINE TARTRATE CALCITRIOL, CALCITRIOL CAPASTAT SULFATE, CAPREOMYCIN SULFATE CARBOPLATIN, CARBOPLATIN DICLOFENAC SODIUM, DICLOFENAC SODIUM ENDOSOL EXTRA, CALCIUM CHLORIDE ERYTHROMYCIN, ERYTHROMYCIN 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) LATANOPROST, LATANOPROST LEVOFLOXACIN, LEVOFLOXACIN LIDOCAINE HYDROCHLORIDE, LIDOCAINE HYDROCHLORIDE LORAZEPAM, LORAZEPAM NEDOCROMIL SODIUM, NEDOCROMIL SODIUM NEOMYCIN AND POLYMYXIN B SULFATES AND BACITRACIN ZINC, BACITRACIN ZINC NEOMYCIN AND POLYMYXIN B SULFATES, BACITRACIN ZINC AND HYDROCORTISONE, BACITRACIN ZINC OFLOXACIN, OFLOXACIN ORPHENADRINE CITRATE, ORPHENADRINE CITRATE SUBLIMAZE PRESERVATIVE FREE, FENTANYL CITRATE SUFENTA PRESERVATIVE FREE, SUFENTANIL CITRATE TERBUTALINE SULFATE, TERBUTALINE SULFATE TROPICACYL, TROPICAMIDE VANCOMYCIN HYDROCHLORIDE, VANCOMYCIN HYDROCHLORIDE AKORN INC * AKORN INC APRACLONIDINE HYDROCHLORIDE, APRACLONIDINE HYDROCHLORIDE CEFTRIAXONE, CEFTRIAXONE SODIUM CIPROFLOXACIN HYDROCHLORIDE, CIPROFLOXACIN HYDROCHLORIDE DECEMBER 2013 - APPROVED DRUG PRODUCT LIST APPENDIX B - B - 6 PRODUCT NAME SORTED BY APPLICANT ** A ** * AKORN INC CLINDAMYCIN PHOSPHATE IN 5% DEXTROSE IN PLASTIC CONTAINER, CLINDAMYCIN PHOSPHATE DILTIAZEM HYDROCHLORIDE, DILTIAZEM HYDROCHLORIDE EPIRUBICIN HYDROCHLORIDE, EPIRUBICIN HYDROCHLORIDE GRANISETRON HYDROCHLORIDE, GRANISETRON HYDROCHLORIDE LABETALOL HYDROCHLORIDE, LABETALOL HYDROCHLORIDE MIDAZOLAM HYDROCHLORIDE, MIDAZOLAM HYDROCHLORIDE NAPHAZOLINE HYDROCHLORIDE AND PHENIRAMINE MALEATE, NAPHAZOLINE HYDROCHLORIDE (OTC) NAPHAZOLINE HYDROCHLORIDE, NAPHAZOLINE HYDROCHLORIDE PANTOPRAZOLE SODIUM, PANTOPRAZOLE SODIUM PROPARACAINE HYDROCHLORIDE, PROPARACAINE HYDROCHLORIDE TRIMETHOPRIM SULFATE AND POLYMYXIN B SULFATE, POLYMYXIN B SULFATE AKRIMAX PHARMS * AKRIMAX PHARMACEUTICALS LLC INDERAL LA, PROPRANOLOL HYDROCHLORIDE ALARA PHARM * ALARA PHARMACEUTICAL CORPORATION LEVO-T, LEVOTHYROXINE SODIUM ** ALCON * ALCON INC TRIESENCE, TRIAMCINOLONE ACETONIDE * ALCON LABORATORIES INC BSS PLUS, CALCIUM CHLORIDE BSS, CALCIUM CHLORIDE CETAMIDE, SULFACETAMIDE SODIUM CYCLOGYL, CYCLOPENTOLATE HYDROCHLORIDE IOPIDINE, APRACLONIDINE HYDROCHLORIDE MIOSTAT, CARBACHOL OMNIPRED, PREDNISOLONE ACETATE ALCON LABS INC * ALCON LABORATORIES INC CYCLOGYL, CYCLOPENTOLATE HYDROCHLORIDE ALCON PHARMA * ALCON RESEARCH LTD AZELASTINE HYDROCHLORIDE, AZELASTINE HYDROCHLORIDE ZADITOR, KETOTIFEN FUMARATE (OTC) ALCON PHARMS LTD * ALCON PHARMACEUTICALS LTD DUREZOL, DIFLUPREDNATE MOXEZA, MOXIFLOXACIN HYDROCHLORIDE NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE, HYDROCORTISONE QOLIANA, BRIMONIDINE TARTRATE TRIFLURIDINE, TRIFLURIDINE ALCON RES * ALCON RESEARCH LTD DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE, DORZOLAMIDE HYDROCHLORIDE ISOPTO CARPINE, PILOCARPINE HYDROCHLORIDE LATANOPROST, LATANOPROST ALCON RES LTD * ALCON RESEARCH LTD ILEVRO, NEPAFENAC SIMBRINZA, BRIMONIDINE TARTRATE ALEMBIC LTD * ALEMBIC LTD IRBESARTAN AND HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE LITHIUM CARBONATE, LITHIUM CARBONATE METRONIDAZOLE, METRONIDAZOLE MODAFINIL, MODAFINIL PRAMIPEXOLE DIHYDROCHLORIDE, PRAMIPEXOLE DIHYDROCHLORIDE ROPINIROLE HYDROCHLORIDE, ROPINIROLE HYDROCHLORIDE THEOPHYLLINE, THEOPHYLLINE VALSARTAN AND HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE ALEMBIC PHARMS LTD * ALEMBIC PHARMACEUTICALS LTD DECEMBER 2013 - APPROVED DRUG PRODUCT LIST APPENDIX B - PRODUCT NAME SORTED BY APPLICANT ** A ** * ALEMBIC PHARMACEUTICALS LTD CLONIDINE HYDROCHLORIDE, CLONIDINE HYDROCHLORIDE DESVENLAFAXINE, DESVENLAFAXINE DONEPEZIL HYDROCHLORIDE, DONEPEZIL HYDROCHLORIDE FAMOTIDINE, FAMOTIDINE FLUOXETINE HYDROCHLORIDE, FLUOXETINE HYDROCHLORIDE HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE IRBESARTAN, IRBESARTAN LAMOTRIGINE, LAMOTRIGINE LEFLUNOMIDE, LEFLUNOMIDE LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE LOSARTAN POTASSIUM, LOSARTAN POTASSIUM MEPROBAMATE, MEPROBAMATE METOPROLOL TARTRATE AND HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE METOPROLOL TARTRATE, METOPROLOL TARTRATE METRONIDAZOLE, METRONIDAZOLE RIVASTIGMINE TARTRATE, RIVASTIGMINE TARTRATE VENLAFAXINE HYDROCHLORIDE, VENLAFAXINE HYDROCHLORIDE ALKEM * ALKEM LABORATORIES LTD AMLODIPINE BESYLATE, AMLODIPINE BESYLATE GABAPENTIN, GABAPENTIN METFORMIN HYDROCHLORIDE, METFORMIN HYDROCHLORIDE ALKEM LABS LTD * ALKEM LABORATORIES LTD CEFUROXIME AXETIL, CEFUROXIME AXETIL CEPHALEXIN, CEPHALEXIN HYDRALAZINE HYDROCHLORIDE, HYDRALAZINE HYDROCHLORIDE LAMOTRIGINE, LAMOTRIGINE MYCOPHENOLATE MOFETIL, MYCOPHENOLATE MOFETIL QUETIAPINE FUMARATE, QUETIAPINE FUMARATE ALKERMES * ALKERMES INC VIVITROL, NALTREXONE ALKERMES GAINESVILLE * ALKERMES GAINESVILLE LLC VERELAN PM, VERAPAMIL HYDROCHLORIDE VERELAN, VERAPAMIL HYDROCHLORIDE ALKOPHARMA USA * ALKOPHARMA USA INC AMPHOTEC, AMPHOTERICIN B ALLERGAN * ALLERGAN ACULAR LS, KETOROLAC TROMETHAMINE ALPHAGAN P, BRIMONIDINE TARTRATE BLEPH-10, SULFACETAMIDE SODIUM ZYMAXID, GATIFLOXACIN * ALLERGAN INC ACULAR, KETOROLAC TROMETHAMINE ACUVAIL, KETOROLAC TROMETHAMINE ACZONE, DAPSONE ALBALON, NAPHAZOLINE HYDROCHLORIDE ALOCRIL, NEDOCROMIL SODIUM ALPHAGAN P, BRIMONIDINE TARTRATE AVAGE, TAZAROTENE COMBIGAN, BRIMONIDINE TARTRATE ELESTAT, EPINASTINE HYDROCHLORIDE LASTACAFT, ALCAFTADINE LATISSE, BIMATOPROST LUMIGAN, BIMATOPROST OCUFLOX, OFLOXACIN OZURDEX, DEXAMETHASONE RESTASIS, CYCLOSPORINE SANCTURA XR, TROSPIUM CHLORIDE SANCTURA, TROSPIUM CHLORIDE B - 7 DECEMBER 2013 - APPROVED DRUG PRODUCT LIST APPENDIX B - B - 8 PRODUCT NAME SORTED BY APPLICANT ** A ** * ALLERGAN INC TAZORAC, TAZAROTENE ZYMAR, GATIFLOXACIN * ALLERGAN PHARMACEUTICAL FML, FLUOROMETHOLONE ALLERQUEST * ALLERQUEST LLC PRE-PEN, BENZYLPENICILLOYL POLYLYSINE ALLIED PHARMA INC * ALLIED PHARMA INC CLARITHROMYCIN, CLARITHROMYCIN GABAPENTIN, GABAPENTIN ALLOS * ALLOS THERAPEUTICS INC FOLOTYN, PRALATREXATE ALMATICA PHARMA INC * ALMATICA PHARMA INC NAPRELAN, NAPROXEN SODIUM ALPHARMA * ALPHARMA USPD INC PREDNISOLONE, PREDNISOLONE VALPROIC ACID, VALPROIC ACID ALPHARMA KING * ALPHARMA PHARMACEUTICALS LLC KING PHARMACEUTICALS EMBEDA, MORPHINE SULFATE ALTAIRE PHARMS INC * ALTAIRE PHARMACEUTICALS INC NAPHAZOLINE HYDROCHLORIDE AND PHENIRAMINE MALEATE, NAPHAZOLINE HYDROCHLORIDE OFLOXACIN, OFLOXACIN ALTERNA TCHP LLC * ALTERNA TCHP LLC CHILDREN'S ELIXSURE, IBUPROFEN (OTC) ALVOGEN * ALVOGEN INC METFORMIN HYDROCHLORIDE, METFORMIN HYDROCHLORIDE TRAMADOL HYDROCHLORIDE, TRAMADOL HYDROCHLORIDE TRAZODONE HYDROCHLORIDE, TRAZODONE HYDROCHLORIDE ALVOGEN INC * ALVOGEN INC DOXORUBICIN HYDROCHLORIDE, DOXORUBICIN HYDROCHLORIDE MACROBID, NITROFURANTOIN MACRODANTIN, NITROFURANTOIN, MACROCRYSTALLINE OXYCODONE AND ACETAMINOPHEN, ACETAMINOPHEN OXYCODONE HYDROCHLORIDE, OXYCODONE HYDROCHLORIDE TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN, ACETAMINOPHEN ALVOGEN PINE BROOK * ALVOGEN PINE BROOK INC DISULFIRAM , DISULFIRAM AM ANTIBIOTICS * AMERICAN ANTIBIOTICS INC AMOXICILLIN, AMOXICILLIN AMAG PHARMS INC * AMAG PHARMACEUTICALS INC FERAHEME, FERUMOXYTOL AMARIN PHARMS * AMARIN PHARMACEUTICALS IRELAND LTD VASCEPA, ICOSAPENT ETHYL AMDERMA PHARMS * AMDERMA PHARMACEUTICALS LLC ECOZA, ECONAZOLE NITRATE AMEDRA PHARMS * AMEDRA PHARMACEUTICALS LLC ADRENACLICK, EPINEPHRINE ALBENZA, ALBENDAZOLE (OTC) DECEMBER 2013 - APPROVED DRUG PRODUCT LIST APPENDIX B - B - 9 PRODUCT NAME SORTED BY APPLICANT ** A ** * AMEDRA PHARMACEUTICALS LLC DARAPRIM, PYRIMETHAMINE DEXEDRINE, DEXTROAMPHETAMINE SULFATE HYDROCORTISONE, HYDROCORTISONE TWINJECT 0.15, EPINEPHRINE TWINJECT 0.3, EPINEPHRINE AMGEN * AMGEN INC SENSIPAR, CINACALCET HYDROCHLORIDE AMNEAL PHARM * AMNEAL PHARMACEUTICAL ACEBUTOLOL HYDROCHLORIDE, ACEBUTOLOL HYDROCHLORIDE BETHANECHOL CHLORIDE, BETHANECHOL CHLORIDE DEMECLOCYCLINE HYDROCHLORIDE, DEMECLOCYCLINE HYDROCHLORIDE FLECAINIDE ACETATE, FLECAINIDE ACETATE FOLIC ACID, FOLIC ACID GUANFACINE HYDROCHLORIDE, GUANFACINE HYDROCHLORIDE HYDROXYZINE HYDROCHLORIDE, HYDROXYZINE HYDROCHLORIDE PRIMIDONE, PRIMIDONE AMNEAL PHARMS * AMNEAL PHARMACEUTICALS ALBUTEROL SULFATE, ALBUTEROL SULFATE BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE , BUPRENORPHINE HYDROCHLORIDE BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE, BUPRENORPHINE HYDROCHLORIDE CETIRIZINE HYDROCHLORIDE, CETIRIZINE HYDROCHLORIDE CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY, CETIRIZINE HYDROCHLORIDE (OTC) CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF, CETIRIZINE HYDROCHLORIDE (OTC) ESCITALOPRAM OXALATE, ESCITALOPRAM OXALATE FELBAMATE, FELBAMATE FOSPHENYTOIN SODIUM, FOSPHENYTOIN SODIUM GABAPENTIN, GABAPENTIN IBUPROFEN, IBUPROFEN (OTC) INDOMETHACIN, INDOMETHACIN LEVETIRACETAM, LEVETIRACETAM LORAZEPAM, LORAZEPAM MECLIZINE HYDROCHLORIDE, MECLIZINE HYDROCHLORIDE METAXALONE, METAXALONE NITROFURANTOIN, NITROFURANTOIN NIZATIDINE, NIZATIDINE NORETHINDRONE ACETATE, NORETHINDRONE ACETATE ONDANSETRON HYDROCHLORIDE, ONDANSETRON HYDROCHLORIDE OXCARBAZEPINE, OXCARBAZEPINE POTASSIUM CHLORIDE, POTASSIUM CHLORIDE PREDNISOLONE SODIUM PHOSPHATE, PREDNISOLONE SODIUM PHOSPHATE PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE, CODEINE PHOSPHATE PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE, DEXTROMETHORPHAN PROMETHAZINE HYDROCHLORIDE AND PHENYLEPHRINE HYDROCHLORIDE, PHENYLEPHRINE PROMETHAZINE HYDROCHLORIDE, PROMETHAZINE HYDROCHLORIDE RANITIDINE HYDROCHLORIDE, RANITIDINE HYDROCHLORIDE RISPERIDONE, RISPERIDONE SILDENAFIL CITRATE, SILDENAFIL CITRATE SPIRONOLACTONE, SPIRONOLACTONE TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN, ACETAMINOPHEN VENLAFAXINE HYDROCHLORIDE, VENLAFAXINE HYDROCHLORIDE WARFARIN SODIUM, WARFARIN SODIUM * AMNEAL PHARMACEUTICALS LLC TRAMADOL HYDROCHLORIDE, TRAMADOL HYDROCHLORIDE * AMNEAL PHARMACEUTICALS OF NEW YORK LLC NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE, ETHINYL ESTRADIOL NORETHINDRONE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE, ETHINYL ESTRADIOL AMNEAL PHARMS NY * AMNEAL PHARMACEUTICALS NY LLC CETIRIZINE HYDROCHLORIDE ALLERGY, CETIRIZINE HYDROCHLORIDE (OTC) CETIRIZINE HYDROCHLORIDE HIVES RELIEF, CETIRIZINE HYDROCHLORIDE (OTC) EXTENDED PHENYTOIN SODIUM, PHENYTOIN SODIUM DECEMBER 2013 - APPROVED DRUG PRODUCT LIST APPENDIX B - PRODUCT NAME SORTED BY APPLICANT ** A ** * AMNEAL PHARMACEUTICALS NY LLC METFORMIN HYDROCHLORIDE, METFORMIN HYDROCHLORIDE NAPROXEN SODIUM, NAPROXEN SODIUM (OTC) PROMETHAZINE HYDROCHLORIDE, PROMETHAZINE HYDROCHLORIDE REPREXAIN, HYDROCODONE BITARTRATE AMPHASTAR PHARM * AMPHASTAR PHARMACEUTICAL INC AMPHADASE, HYALURONIDASE ENOXAPARIN SODIUM (PRESERVATIVE FREE), ENOXAPARIN SODIUM AMPHASTAR PHARMS INC * AMPHASTAR PHARMACEUTICALS INC CORTROSYN, COSYNTROPIN AMPOLGEN * AMPOLGEN PHARMACEUTICALS LLC SODIUM PHENYLBUTYRATE, SODIUM PHENYLBUTYRATE AMYLIN * AMYLIN PHARMACEUTICALS INC BYDUREON, EXENATIDE SYNTHETIC BYETTA, EXENATIDE SYNTHETIC AMYLIN PHARMS LLC * AMYLIN PHARMACEUTICALS LLC SYMLIN, PRAMLINTIDE ACETATE ANBEX * ANBEX INC IOSAT, POTASSIUM IODIDE (OTC) ANCHEN PHARMS * ANCHEN PHARMACEUTICALS INC BUPROPION HYDROCHLORIDE, BUPROPION HYDROCHLORIDE CLONIDINE HYDROCHLORIDE , CLONIDINE HYDROCHLORIDE FENOFIBRIC ACID, CHOLINE FENOFIBRATE FLUVOXAMINE MALEATE, FLUVOXAMINE MALEATE LAMOTRIGINE, LAMOTRIGINE LEVETIRACETAM, LEVETIRACETAM POTASSIUM CHLORIDE, POTASSIUM CHLORIDE TAMSULOSIN HYDROCHLORIDE, TAMSULOSIN HYDROCHLORIDE TRAMADOL HYDROCHLORIDE, TRAMADOL HYDROCHLORIDE TRETINOIN, TRETINOIN ZOLPIDEM TARTRATE, ZOLPIDEM TARTRATE * ANCHEN PHARMACEUTICALS TAIWAN INC DIVALPROEX SODIUM, DIVALPROEX SODIUM * ANCHEN PHARMACEUTICALS, INC ALPRAZOLAM, ALPRAZOLAM CIPROFLOXACIN EXTENDED RELEASE, CIPROFLOXACIN VENLAFAXINE HYDROCHLORIDE, VENLAFAXINE HYDROCHLORIDE ANDRX LABS LLC * ANDRX LABS LLC ALTOPREV, LOVASTATIN FORTAMET, METFORMIN HYDROCHLORIDE ANGELINI PHARMA * ANGELINI PHARMA INC OLEPTRO, TRAZODONE HYDROCHLORIDE ANI PHARMS * ANI PHARMACEUTICALS INC CORTENEMA, HYDROCORTISONE LACTULOSE, LACTULOSE LUVOX, FLUVOXAMINE MALEATE METOCLOPRAMIDE HYDROCHLORIDE, METOCLOPRAMIDE HYDROCHLORIDE REGLAN, METOCLOPRAMIDE HYDROCHLORIDE ANTARES PHARMA INC * ANTARES PHARMA INC OTREXUP, METHOTREXATE ANTIBIOTICE * ANTIBIOTICE SA NAFCILLIN SODIUM, NAFCILLIN SODIUM B - 10 DECEMBER 2013 - APPROVED DRUG PRODUCT LIST APPENDIX B - PRODUCT NAME SORTED BY APPLICANT ** A ** ANTIBIOTICOS BRASIL * ANTIBIOTICOS DO BRASIL LTDA CEFOXITIN, CEFOXITIN SODIUM APGDI * ASTELLAS PHARMA GLOBAL DEVELOPMENT INC MYRBETRIQ, MIRABEGRON APOPHARMA INC * APOPHARMA INC FERRIPROX, DEFERIPRONE APOTEX * APOTEX CORP LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE PRAVASTATIN SODIUM, PRAVASTATIN SODIUM TERBINAFINE HYDROCHLORIDE, TERBINAFINE HYDROCHLORIDE * APOTEX INC ALENDRONATE SODIUM, ALENDRONATE SODIUM AMLODIPINE BESYLATE, AMLODIPINE BESYLATE CEFUROXIME AXETIL, CEFUROXIME AXETIL CIMETIDINE, CIMETIDINE (OTC) DILT-CD, DILTIAZEM HYDROCHLORIDE DONEPEZIL HYDROCHLORIDE, DONEPEZIL HYDROCHLORIDE EPINASTINE HYDROCHLORIDE, EPINASTINE HYDROCHLORIDE EPLERENONE, EPLERENONE FAMCICLOVIR, FAMCICLOVIR HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE LAMIVUDINE, LAMIVUDINE METFORMIN HYDROCHLORIDE, METFORMIN HYDROCHLORIDE MYCOPHENOLATE MOFETIL, MYCOPHENOLATE MOFETIL OMEPRAZOLE, OMEPRAZOLE ONDANSETRON HYDROCHLORIDE, ONDANSETRON HYDROCHLORIDE PAROXETINE HYDROCHLORIDE, PAROXETINE HYDROCHLORIDE PERINDOPRIL ERBUMINE, PERINDOPRIL ERBUMINE RAMIPRIL, RAMIPRIL ROPINIROLE HYDROCHLORIDE, ROPINIROLE HYDROCHLORIDE TAMOXIFEN CITRATE, TAMOXIFEN CITRATE TRAZODONE HYDROCHLORIDE, TRAZODONE HYDROCHLORIDE TROSPIUM CHLORIDE, TROSPIUM CHLORIDE APOTEX CORP * APOTEX CORP AMIODARONE HYDROCHLORIDE, AMIODARONE HYDROCHLORIDE AZITHROMYCIN, AZITHROMYCIN CABERGOLINE, CABERGOLINE CLARITHROMYCIN, CLARITHROMYCIN LOSARTAN POTASSIUM, LOSARTAN POTASSIUM MONTELUKAST SODIUM, MONTELUKAST SODIUM MYCOPHENOLATE MOFETIL, MYCOPHENOLATE MOFETIL NARATRIPTAN, NARATRIPTAN QUINAPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE RILUZOLE, RILUZOLE SILDENAFIL CITRATE, SILDENAFIL CITRATE TOLTERODINE TARTRATE, TOLTERODINE TARTRATE VERAPAMIL HYDROCHLORIDE, VERAPAMIL HYDROCHLORIDE ZIPRASIDONE HYDROCHLORIDE, ZIPRASIDONE HYDROCHLORIDE APOTEX INC * APOTEX INC ABACAVIR SULFATE, ABACAVIR SULFATE ALFUZOSIN HYDROCHLORIDE, ALFUZOSIN HYDROCHLORIDE ALPRAZOLAM, ALPRAZOLAM AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE, AMLODIPINE BESYLATE ANASTROZOLE, ANASTROZOLE ATORVASTATIN CALCIUM, ATORVASTATIN CALCIUM AZELASTINE HYDROCHLORIDE, AZELASTINE HYDROCHLORIDE CALCITONIN-SALMON, CALCITONIN SALMON CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE, CANDESARTAN CILEXETIL CANDESARTAN CILEXETIL, CANDESARTAN CILEXETIL B - 11 DECEMBER 2013 - APPROVED DRUG PRODUCT LIST APPENDIX B - PRODUCT NAME SORTED BY APPLICANT ** A ** * APOTEX INC CARBAMAZEPINE, CARBAMAZEPINE CARBIDOPA AND LEVODOPA, CARBIDOPA CEFPROZIL, CEFPROZIL CETIRIZINE HYDROCHLORIDE ALLERGY, CETIRIZINE HYDROCHLORIDE CEVIMELINE, CEVIMELINE HYDROCHLORIDE CLOPIDOGREL BISULFATE, CLOPIDOGREL BISULFATE ESCITALOPRAM OXALATE, ESCITALOPRAM OXALATE FENOFIBRATE (MICRONIZED), FENOFIBRATE GRANISETRON HYDROCHLORIDE, GRANISETRON HYDROCHLORIDE IBANDRONATE SODIUM, IBANDRONATE SODIUM IMIQUIMOD, IMIQUIMOD IRBESARTAN AND HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE IRBESARTAN, IRBESARTAN LAMIVUDINE, LAMIVUDINE LAMOTRIGINE, LAMOTRIGINE LETROZOLE, LETROZOLE LEVETIRACETAM, LEVETIRACETAM LEVOFLOXACIN, LEVOFLOXACIN LOVASTATIN, LOVASTATIN MILRINONE LACTATE IN DEXTROSE 5%, MILRINONE LACTATE MOEXIPRIL HYDROCHLORIDE, MOEXIPRIL HYDROCHLORIDE MONTELUKAST SODIUM, MONTELUKAST SODIUM MYCOPHENOLIC ACID, MYCOPHENOLIC ACID NABUMETONE, NABUMETONE NEVIRAPINE, NEVIRAPINE OFLOXACIN, OFLOXACIN OLANZAPINE, OLANZAPINE OXCARBAZEPINE, OXCARBAZEPINE PANTOPRAZOLE SODIUM, PANTOPRAZOLE SODIUM PRAMIPEXOLE DIHYDROCHLORIDE, PRAMIPEXOLE DIHYDROCHLORIDE QUETIAPINE FUMARATE, QUETIAPINE FUMARATE RANITIDINE HYDROCHLORIDE, RANITIDINE HYDROCHLORIDE (OTC) RASAGILINE MESYLATE, RASAGILINE MESYLATE RISPERIDONE, RISPERIDONE RIVASTIGMINE TARTRATE, RIVASTIGMINE TARTRATE RIZATRIPTAN BENZOATE, RIZATRIPTAN BENZOATE SERTRALINE HYDROCHLORIDE, SERTRALINE HYDROCHLORIDE SUMATRIPTAN SUCCINATE, SUMATRIPTAN SUCCINATE TIZANIDINE HYDROCHLORIDE, TIZANIDINE HYDROCHLORIDE TRAZODONE HYDROCHLORIDE, TRAZODONE HYDROCHLORIDE TRIAMTERENE AND HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE VALSARTAN AND HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE ZOLMITRIPTAN, ZOLMITRIPTAN ZOLPIDEM TARTRATE, ZOLPIDEM TARTRATE * APOTEX INC ETOBICOKE SITE BALSALAZIDE DISODIUM, BALSALAZIDE DISODIUM CARVEDILOL, CARVEDILOL GABAPENTIN, GABAPENTIN MELOXICAM, MELOXICAM MIDODRINE HYDROCHLORIDE, MIDODRINE HYDROCHLORIDE MIRTAZAPINE, MIRTAZAPINE TOPIRAMATE, TOPIRAMATE * APOTEX INC RICHMOND HILL AZELASTINE HYDROCHLORIDE, AZELASTINE HYDROCHLORIDE FLUNISOLIDE, FLUNISOLIDE FLUTICASONE PROPIONATE, FLUTICASONE PROPIONATE KETOROLAC TROMETHAMINE, KETOROLAC TROMETHAMINE RISPERIDONE, RISPERIDONE * APOTEX INC. GALANTAMINE HYDROBROMIDE, GALANTAMINE HYDROBROMIDE APOTHECON * APOTHECON INC DIV BRISTOL MYERS SQUIBB KENALOG-10, TRIAMCINOLONE ACETONIDE KENALOG-40, TRIAMCINOLONE ACETONIDE (OTC) B - 12 DECEMBER 2013 - APPROVED DRUG PRODUCT LIST APPENDIX B - PRODUCT NAME SORTED BY APPLICANT ** A ** APTALIS PHARMA * APTALIS PHARMA LTD RECTIV, NITROGLYCERIN APTALIS PHARMA US * APTALIS PHARMA US INC BENTYL PRESERVATIVE FREE, DICYCLOMINE HYDROCHLORIDE BENTYL, DICYCLOMINE HYDROCHLORIDE CANASA, MESALAMINE CARAFATE, SUCRALFATE PYLERA, BISMUTH SUBCITRATE POTASSIUM ULTRESA, PANCRELIPASE (AMYLASE URSO 250, URSODIOL URSO FORTE, URSODIOL VIOKACE, PANCRELIPASE (AMYLASE ZENPEP, PANCRELIPASE (AMYLASE APTALIS PHARMATECH * APTALIS PHARMATECH INC PROPRANOLOL HYDROCHLORIDE, PROPRANOLOL HYDROCHLORIDE AQUA PHARMS * AQUA PHARMACEUTICALS CORDRAN SP, FLURANDRENOLIDE CORDRAN, FLURANDRENOLIDE MONODOX, DOXYCYCLINE * AQUA PHARMACEUTICALS LLC FLUOROPLEX, FLUOROURACIL XOLEGEL, KETOCONAZOLE ARBOR PHARMS INC * ARBOR PHARMACEUTICALS INC AMPHETAMINE SULFATE, AMPHETAMINE SULFATE BIDIL, HYDRALAZINE HYDROCHLORIDE E.E.S. 200, ERYTHROMYCIN ETHYLSUCCINATE E.E.S. 400, ERYTHROMYCIN ETHYLSUCCINATE E.E.S., ERYTHROMYCIN ETHYLSUCCINATE ERY-TAB, ERYTHROMYCIN ERYPED, ERYTHROMYCIN ETHYLSUCCINATE ERYTHROCIN STEARATE, ERYTHROMYCIN STEARATE ERYTHROMYCIN ETHYLSUCCINATE, ERYTHROMYCIN ETHYLSUCCINATE ERYTHROMYCIN, ERYTHROMYCIN NYMALIZE, NIMODIPINE PCE, ERYTHROMYCIN PEDIAMYCIN 400, ERYTHROMYCIN ETHYLSUCCINATE PEDIAMYCIN, ERYTHROMYCIN ETHYLSUCCINATE ARBOR PHARMS LLC * ARBOR PHARMACEUTICALS LLC EDARBI, AZILSARTAN KAMEDOXOMIL EDARBYCLOR, AZILSARTAN KAMEDOXOMIL GLIADEL, CARMUSTINE ARCO PHARMS LLC * ARCO PHARMACEUTICALS LLC THYROSHIELD, POTASSIUM IODIDE (OTC) AREVA PHARMS * AREVA PHARMACEUTICALS INC PAMIDRONATE DISODIUM, PAMIDRONATE DISODIUM ARIAD * ARIAD PHARMACEUTICALS INC ICLUSIG, PONATINIB HYDROCHLORIDE ASCEND * ASCEND THERAPEUTICS INC ESTROGEL, ESTRADIOL ASPEN GLOBAL * ASPEN GLOBAL INC MYLERAN, BUSULFAN ASPEN GLOBAL INC * ASPEN GLOBAL INC B - 13 DECEMBER 2013 - APPROVED DRUG PRODUCT LIST APPENDIX B - PRODUCT NAME SORTED BY APPLICANT ** A ** * ASPEN GLOBAL INC LEUKERAN, CHLORAMBUCIL THIOGUANINE, THIOGUANINE ASTELLAS * ASTELLAS PHARMA US INC ADENOSCAN, ADENOSINE ASTAGRAF XL, TACROLIMUS LEXISCAN, REGADENOSON MYCAMINE, MICAFUNGIN SODIUM PROGRAF, TACROLIMUS PROTOPIC, TACROLIMUS VAPRISOL IN 5% DEXTROSE IN PLASTIC CONTAINER, CONIVAPTAN HYDROCHLORIDE XTANDI, ENZALUTAMIDE ASTRAZENECA * ASTRAZENECA LP DUTOPROL, HYDROCHLOROTHIAZIDE ENTOCORT EC, BUDESONIDE 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 TOPROL-XL, METOPROLOL SUCCINATE * ASTRAZENECA PHARMACEUTICALS LP ATACAND HCT, CANDESARTAN CILEXETIL ATACAND, CANDESARTAN CILEXETIL FASLODEX, FULVESTRANT PLENDIL, FELODIPINE SEROQUEL XR, QUETIAPINE FUMARATE ZOMIG, ZOLMITRIPTAN ZOMIG-ZMT, ZOLMITRIPTAN * ASTRAZENECA UK LTD ACCOLATE, ZAFIRLUKAST ARIMIDEX, ANASTROZOLE CASODEX, BICALUTAMIDE MERREM, MEROPENEM ZESTORETIC, HYDROCHLOROTHIAZIDE ZESTRIL, LISINOPRIL ASTRAZENECA LP * ASTRAZENECA LP BRILINTA, TICAGRELOR ATON * ATON PHARMA INC CUPRIMINE, PENICILLAMINE EDECRIN, ETHACRYNATE SODIUM EDECRIN, ETHACRYNIC ACID LACRISERT, HYDROXYPROPYL CELLULOSE LODOSYN, CARBIDOPA SYPRINE, TRIENTINE HYDROCHLORIDE TIMOPTIC IN OCUDOSE, TIMOLOL MALEATE TIMOPTIC, TIMOLOL MALEATE ATON PHARMA VPNA * ATON PHARMA DIV VALEANT PHARMACEUTICALS NORTH AMERICA LLC DEMSER, METYROSINE AUROBINDO * AUROBINDO PHARMA LTD AMOXICILLIN, AMOXICILLIN CEFADROXIL, CEFADROXIL/CEFADROXIL HEMIHYDRATE CITALOPRAM HYDROBROMIDE, CITALOPRAM HYDROBROMIDE CLARITHROMYCIN, CLARITHROMYCIN B - 14 DECEMBER 2013 - APPROVED DRUG PRODUCT LIST APPENDIX B - PRODUCT NAME SORTED BY APPLICANT ** A ** * AUROBINDO PHARMA LTD DIDANOSINE, DIDANOSINE DONEPEZIL HYDROCHLORIDE, DONEPEZIL HYDROCHLORIDE LISINOPRIL AND HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE LISINOPRIL, LISINOPRIL METFORMIN HYDROCHLORIDE, METFORMIN HYDROCHLORIDE MIRTAZAPINE, MIRTAZAPINE NEVIRAPINE, NEVIRAPINE ZIDOVUDINE, ZIDOVUDINE AUROBINDO PHARM * AUROBINDO PHARMA USA INC FLUCONAZOLE, FLUCONAZOLE FLUOXETINE HYDROCHLORIDE, FLUOXETINE HYDROCHLORIDE GABAPENTIN, GABAPENTIN LEVETIRACETAM, LEVETIRACETAM RANITIDINE HYDROCHLORIDE, RANITIDINE HYDROCHLORIDE AUROBINDO PHARMA * AUROBINDO PHARMA AMPICILLIN AND SULBACTAM, AMPICILLIN SODIUM * AUROBINDO PHARMA LTD ALENDRONATE SODIUM, ALENDRONATE SODIUM AMLODIPINE BESYLATE, AMLODIPINE BESYLATE AMPICILLIN SODIUM, AMPICILLIN SODIUM ATENOLOL, ATENOLOL BENAZEPRIL HYDROCHLORIDE, BENAZEPRIL HYDROCHLORIDE BISOPROLOL FUMARATE, BISOPROLOL FUMARATE CARISOPRODOL, CARISOPRODOL CARVEDILOL, CARVEDILOL CEFADROXIL, CEFADROXIL/CEFADROXIL HEMIHYDRATE CEFDINIR, CEFDINIR CEFPODOXIME PROXETIL, CEFPODOXIME PROXETIL CEFPROZIL, CEFPROZIL 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 FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE, FOSINOPRIL SODIUM GLYBURIDE AND METFORMIN HYDROCHLORIDE, GLYBURIDE GLYBURIDE, GLYBURIDE HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE LAMOTRIGINE, LAMOTRIGINE LEVETIRACETAM, LEVETIRACETAM LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE LOSARTAN POTASSIUM, LOSARTAN POTASSIUM 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 B - 15 DECEMBER 2013 - APPROVED DRUG PRODUCT LIST APPENDIX B - PRODUCT NAME SORTED BY APPLICANT ** A ** * AUROBINDO PHARMA LTD SUMATRIPTAN SUCCINATE, SUMATRIPTAN SUCCINATE TERBINAFINE HYDROCHLORIDE, TERBINAFINE HYDROCHLORIDE TOPIRAMATE, TOPIRAMATE TORSEMIDE, TORSEMIDE TRANDOLAPRIL, TRANDOLAPRIL VALACYCLOVIR HYDROCHLORIDE, VALACYCLOVIR HYDROCHLORIDE VENLAFAXINE HYDROCHLORIDE, VENLAFAXINE HYDROCHLORIDE ZALEPLON, ZALEPLON ZOLPIDEM TARTRATE, ZOLPIDEM TARTRATE AUROBINDO PHARMA LTD * AUROBINDO PHARMA LIMITED DIVALPROEX SODIUM, DIVALPROEX SODIUM FOSINOPRIL SODIUM, FOSINOPRIL SODIUM GALANTAMINE HYDROBROMIDE, GALANTAMINE HYDROBROMIDE LEVOFLOXACIN, LEVOFLOXACIN VENLAFAXINE HYDROCHLORIDE, VENLAFAXINE HYDROCHLORIDE * AUROBINDO PHARMA LTD ABACAVIR SULFATE, ABACAVIR SULFATE ACYCLOVIR SODIUM, ACYCLOVIR SODIUM ALFUZOSIN HYDROCHLORIDE, ALFUZOSIN HYDROCHLORIDE AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE, AMLODIPINE BESYLATE AMOXICILLIN AND CLAVULANATE POTASSIUM, AMOXICILLIN BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREE, BUPIVACAINE HYDROCHLORIDE CEFPODOXIME PROXETIL, CEFPODOXIME PROXETIL CLINDAMYCIN PALMITATE HYDROCHLORIDE, CLINDAMYCIN PALMITATE HYDROCHLORIDE CLOPIDOGREL BISULFATE, CLOPIDOGREL BISULFATE DULOXETINE HYDROCHLORIDE, DULOXETINE HYDROCHLORIDE ESCITALOPRAM OXALATE, ESCITALOPRAM OXALATE FAMCICLOVIR, FAMCICLOVIR FELODIPINE, FELODIPINE FINASTERIDE, FINASTERIDE GABAPENTIN, GABAPENTIN GLIMEPIRIDE, GLIMEPIRIDE IRBESARTAN AND HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE IRBESARTAN, IRBESARTAN LAMIVUDINE AND ZIDOVUDINE, LAMIVUDINE LAMIVUDINE, LAMIVUDINE LEVOFLOXACIN, LEVOFLOXACIN LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE, LIDOCAINE HYDROCHLORIDE METFORMIN HYDROCHLORIDE, METFORMIN HYDROCHLORIDE MINOCYCLINE HYDROCHLORIDE, MINOCYCLINE HYDROCHLORIDE MODAFINIL, MODAFINIL MONTELUKAST SODIUM, MONTELUKAST SODIUM NAFCILLIN SODIUM, NAFCILLIN SODIUM NAPROXEN SODIUM, NAPROXEN SODIUM OLANZAPINE, OLANZAPINE ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE, ONDANSETRON HYDROCHLORIDE ONDANSETRON HYDROCHLORIDE, ONDANSETRON HYDROCHLORIDE OXACILLIN SODIUM, OXACILLIN SODIUM PANTOPRAZOLE SODIUM, PANTOPRAZOLE SODIUM PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE, METFORMIN HYDROCHLORIDE PIOGLITAZONE HYDROCHLORIDE, PIOGLITAZONE HYDROCHLORIDE PIPERACILLIN AND TAZOBACTAM, PIPERACILLIN SODIUM PRAMIPEXOLE DIHYDROCHLORIDE, PRAMIPEXOLE DIHYDROCHLORIDE QUETIAPINE FUMARATE, QUETIAPINE FUMARATE QUINAPRIL HYDROCHLORIDE, QUINAPRIL HYDROCHLORIDE RAMIPRIL, RAMIPRIL RIZATRIPTAN BENZOATE, RIZATRIPTAN BENZOATE SUMATRIPTAN SUCCINATE, SUMATRIPTAN SUCCINATE TAMSULOSIN HYDROCHLORIDE, TAMSULOSIN HYDROCHLORIDE VALSARTAN AND HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE * AUROBINDO PHARMA LTD INC CEFPROZIL, CEFPROZIL CEFUROXIME AXETIL, CEFUROXIME AXETIL B - 16 DECEMBER 2013 - APPROVED DRUG PRODUCT LIST APPENDIX B - B - 17 PRODUCT NAME SORTED BY APPLICANT ** A ** * AUROBINDO PHARMA LTD INC CEPHALEXIN, CEPHALEXIN CITALOPRAM HYDROBROMIDE, CITALOPRAM HYDROBROMIDE MIRTAZAPINE, MIRTAZAPINE ZIDOVUDINE, ZIDOVUDINE AUROBINDO PHARMA USA * AUROBINDO PHARMA USA INC ALPRAZOLAM, ALPRAZOLAM NAPROXEN, NAPROXEN AUROLIFE PHARMA LLC * AUROLIFE PHARMA LLC ACETAMINOPHEN AND CODEINE PHOSPHATE, ACETAMINOPHEN DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE, AMPHETAMINE DEXTROAMPHETAMINE SULFATE, DEXTROAMPHETAMINE SULFATE GLYCOPYRROLATE, GLYCOPYRROLATE HYDROCODONE BITARTRATE AND ACETAMINOPHEN, ACETAMINOPHEN OXYCODONE AND ACETAMINOPHEN, ACETAMINOPHEN OXYCODONE HYDROCHLORIDE, OXYCODONE HYDROCHLORIDE AUSTARPHARMA LLC * AUSTARPHARMA LLC ALENDRONATE SODIUM, ALENDRONATE SODIUM METHOCARBAMOL, METHOCARBAMOL SERTRALINE HYDROCHLORIDE, SERTRALINE HYDROCHLORIDE AUXILIUM PHARMS * AUXILIUM PHARMACEUTICALS INC TESTIM, TESTOSTERONE AVACOR PRODS * AVACOR PRODUCTS LLC MINOXIDIL EXTRA STRENGTH (FOR MEN), MINOXIDIL (OTC) AVANIR PHARMS * AVANIR PHARMACEUTICALS INC NUEDEXTA, DEXTROMETHORPHAN HYDROBROMIDE AVANTHI INC * AVANTHI INC CHLORPHENIRAMINE MALEATE, CHLORPHENIRAMINE MALEATE (OTC) DEXBROMPHENIRAMINE MALEATE AND PSEUDOEPHEDRINE SULFATE, DEXBROMPHENIRAMINE MALEATE DIETHYLPROPION HYDROCHLORIDE, DIETHYLPROPION HYDROCHLORIDE INDOMETHACIN, INDOMETHACIN OXYCODONE HYDROCHLORIDE, OXYCODONE HYDROCHLORIDE OXYMORPHONE HYDROCHLORIDE, OXYMORPHONE HYDROCHLORIDE AVEMA PHARMA * AVEMA PHARMA SOLUTIONS IBUPROFEN, IBUPROFEN (OTC) AVENT * AVENT INC PYTEST KIT, UREA, C-14 PYTEST, UREA, C-14 AVEVA * AVEVA DRUG DELIVERY SYSTEMS INC CLONIDINE, CLONIDINE FENTANYL-100, FENTANYL FENTANYL-25, FENTANYL FENTANYL-50, FENTANYL FENTANYL-75, FENTANYL NICOTINE, NICOTINE (OTC) AVID RADIOPHARMS INC * AVID RADIOPHARMACEUTICALS INC AMYVID, FLORBETAPIR F-18 AZTIQ PHARMA * AZTIQ PHARMA INC TODAY, NONOXYNOL-9 (OTC) ** B BRAUN B ** DECEMBER 2013 - APPROVED DRUG PRODUCT LIST APPENDIX B - B - 18 PRODUCT NAME SORTED BY APPLICANT ** B ** * B BRAUN MEDICAL INC AMINO ACIDS, AMINO ACIDS BALANCED SALT, CALCIUM CHLORIDE BRETYLIUM TOSYLATE IN DEXTROSE 5% IN PLASTIC CONTAINER, BRETYLIUM TOSYLATE CEFAZOLIN AND DEXTROSE, CEFAZOLIN SODIUM CEFEPIME AND DEXTROSE IN DUPLEX CONTAINER, CEFEPIME HYDROCHLORIDE CEFOTETAN AND DEXTROSE IN DUPLEX CONTAINER, CEFOTETAN DISODIUM CEFOXITIN AND DEXTROSE IN DUPLEX CONTAINER, CEFOXITIN SODIUM CEFTAZIDIME IN DEXTROSE CONTAINER, CEFTAZIDIME CEFTRIAXONE AND DEXTROSE IN DUPLEX CONTAINER, CEFTRIAXONE SODIUM CEFUROXIME AND DEXTROSE IN DUPLEX CONTAINER, CEFUROXIME SODIUM DEXTROSE 10% IN PLASTIC CONTAINER, DEXTROSE DEXTROSE 5% IN ACETATED RINGER'S IN PLASTIC CONTAINER, CALCIUM CHLORIDE DEXTROSE 5% IN PLASTIC CONTAINER, DEXTROSE DIALYTE CONCENTRATE W/ DEXTROSE 30% IN PLASTIC CONTAINER, CALCIUM CHLORIDE DIALYTE CONCENTRATE W/ DEXTROSE 50% IN PLASTIC CONTAINER, CALCIUM CHLORIDE FREAMINE HBC 6.9%, AMINO ACIDS FREAMINE III 10%, AMINO ACIDS FREAMINE III 8.5%, AMINO ACIDS GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, GENTAMICIN SULFATE HEPARIN SODIUM 1,000 UNITS IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, HEPARIN 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 PLASTIC CONTAINER, CALCIUM CHLORIDE 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 MILRINONE LACTATE IN DEXTROSE 5% IN PLASTIC CONTAINER, MILRINONE LACTATE NEPHRAMINE 5.4%, AMINO ACIDS SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, SODIUM CHLORIDE STERILE WATER FOR INJECTION IN PLASTIC CONTAINER, STERILE WATER FOR INJECTION STERILE WATER IN PLASTIC CONTAINER, STERILE WATER FOR IRRIGATION TROPHAMINE 10%, AMINO ACIDS TROPHAMINE, AMINO ACIDS BAJAJ MEDICAL LLC * BAJAJ MECICAL LLC DYNA-HEX, CHLORHEXIDINE GLUCONATE (OTC) BANNER PHARMACAPS * BANNER PHARMACAPS INC AMANTADINE HYDROCHLORIDE, AMANTADINE HYDROCHLORIDE BENZONATATE, BENZONATATE CALCITRIOL, CALCITRIOL CETIRIZINE HYDROCHLORIDE ALLERGY, CETIRIZINE HYDROCHLORIDE (OTC) CETIRIZINE HYDROCHLORIDE HIVES RELIEF, CETIRIZINE HYDROCHLORIDE (OTC) DUTASTERIDE, DUTASTERIDE ETHOSUXIMIDE, ETHOSUXIMIDE IBUPROFEN AND DIPHENHYDRAMINE HYDROCHLORIDE, DIPHENHYDRAMINE HYDROCHLORIDE (OTC) IBUPROFEN, IBUPROFEN (OTC) LOPERAMIDE HYDROCHLORIDE, LOPERAMIDE HYDROCHLORIDE (OTC) MIDOL LIQUID GELS, IBUPROFEN (OTC) NAPROXEN SODIUM, NAPROXEN SODIUM (OTC) NIMODIPINE, NIMODIPINE PROGESTERONE, PROGESTERONE ZONISAMIDE, ZONISAMIDE BARR * BARR LABORATORIES INC ALPRAZOLAM, ALPRAZOLAM AMIODARONE HYDROCHLORIDE, AMIODARONE HYDROCHLORIDE ANAGRELIDE HYDROCHLORIDE, ANAGRELIDE HYDROCHLORIDE ARANELLE, ETHINYL ESTRADIOL ASPIRIN AND DIPYRIDAMOLE, ASPIRIN BALZIVA-28, ETHINYL ESTRADIOL DECEMBER 2013 - APPROVED DRUG PRODUCT LIST APPENDIX B - B - 19 PRODUCT NAME SORTED BY APPLICANT ** B ** * BARR LABORATORIES INC BUPRENORPHINE HYDROCHLORIDE, BUPRENORPHINE HYDROCHLORIDE CAMILA, NORETHINDRONE CLONAZEPAM, CLONAZEPAM CLONIDINE, CLONIDINE DANAZOL, DANAZOL DEMECLOCYCLINE HYDROCHLORIDE, DEMECLOCYCLINE HYDROCHLORIDE DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE, AMPHETAMINE DEXTROAMPHETAMINE SULFATE, DEXTROAMPHETAMINE SULFATE DIDANOSINE, DIDANOSINE DIPHENHYDRAMINE HYDROCHLORIDE, DIPHENHYDRAMINE HYDROCHLORIDE DONEPEZIL HYDROCHLORIDE, DONEPEZIL HYDROCHLORIDE DROSPIRENONE AND ETHINYL ESTRADIOL, DROSPIRENONE DUTASTERIDE, DUTASTERIDE ERRIN, NORETHINDRONE ERYTHROMYCIN ETHYLSUCCINATE AND SULFISOXAZOLE ACETYL, ERYTHROMYCIN ETHYLSUCCINATE ESTRADIOL AND NORETHINDRONE ACETATE, ESTRADIOL ESTRADIOL AND NORGESTIMATE, ESTRADIOL ETHAMBUTOL HYDROCHLORIDE, ETHAMBUTOL HYDROCHLORIDE FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE, FEXOFENADINE FEXOFENADINE HYDROCHLORIDE, FEXOFENADINE HYDROCHLORIDE FLECAINIDE ACETATE, FLECAINIDE ACETATE FLUDROCORTISONE ACETATE, FLUDROCORTISONE ACETATE FLUOXETINE HYDROCHLORIDE, FLUOXETINE HYDROCHLORIDE FLUVOXAMINE MALEATE, FLUVOXAMINE MALEATE GALANTAMINE HYDROBROMIDE, GALANTAMINE HYDROBROMIDE HYDROMORPHONE HYDROCHLORIDE, HYDROMORPHONE HYDROCHLORIDE HYDROXYUREA, HYDROXYUREA HYDROXYZINE PAMOATE, HYDROXYZINE PAMOATE 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 MEFLOQUINE HYDROCHLORIDE, MEFLOQUINE HYDROCHLORIDE METFORMIN HYDROCHLORIDE, METFORMIN HYDROCHLORIDE NIACIN, NIACIN NICARDIPINE HYDROCHLORIDE, NICARDIPINE HYDROCHLORIDE NORETHINDRONE ACETATE, NORETHINDRONE ACETATE NORETHINDRONE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE, ETHINYL ESTRADIOL 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 PHENTERMINE HYDROCHLORIDE, PHENTERMINE HYDROCHLORIDE PORTIA-28, ETHINYL ESTRADIOL PRAMIPEXOLE DIHYDROCHLORIDE, PRAMIPEXOLE DIHYDROCHLORIDE SPRINTEC, ETHINYL ESTRADIOL TEMOZOLOMIDE, TEMOZOLOMIDE TREXALL, METHOTREXATE SODIUM TRI-LEGEST 21, ETHINYL ESTRADIOL TRI-LEGEST FE, ETHINYL ESTRADIOL TRI-SPRINTEC, ETHINYL ESTRADIOL ZONISAMIDE, ZONISAMIDE BARR LABS DIV TEVA * BARR LABORATORIES INC SUB TEVA PHARMACEUTICALS USA ACAMPROSATE CALCIUM, ACAMPROSATE CALCIUM BARR LABS INC * BARR LABORATORIES INC ACITRETIN, ACITRETIN DEXTROAMP SACCHARATE,AMP ASPARTATE,DEXTROAMP SULFATE AND AMP SULFATE, AMPHETAMINE DECEMBER 2013 - APPROVED DRUG PRODUCT LIST APPENDIX B - B - 20 PRODUCT NAME SORTED BY APPLICANT ** B ** * BARR LABORATORIES INC ESTRADIOL, ESTRADIOL METHYLPHENIDATE HYDROCHLORIDE, METHYLPHENIDATE HYDROCHLORIDE MINOCYCLINE HYDROCHLORIDE, MINOCYCLINE HYDROCHLORIDE NIMODIPINE, NIMODIPINE NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL, ETHINYL ESTRADIOL OLANZAPINE, OLANZAPINE OXYCODONE HYDROCHLORIDE AND IBUPROFEN, IBUPROFEN TRETINOIN, TRETINOIN BAUSCH AND LOMB * BAUSCH AND LOMB INC ALAWAY, KETOTIFEN FUMARATE (OTC) ALBUTEROL SULFATE, ALBUTEROL SULFATE ALREX, LOTEPREDNOL ETABONATE BESIVANCE, BESIFLOXACIN HYDROCHLORIDE DICLOFENAC SODIUM, DICLOFENAC SODIUM DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE, DORZOLAMIDE HYDROCHLORIDE DORZOLAMIDE HYDROCHLORIDE, DORZOLAMIDE HYDROCHLORIDE FLURBIPROFEN SODIUM, FLURBIPROFEN SODIUM IPRATROPIUM BROMIDE, IPRATROPIUM BROMIDE ISTALOL, TIMOLOL MALEATE LATANOPROST, LATANOPROST LOTEMAX, LOTEPREDNOL ETABONATE MIOCHOL-E, ACETYLCHOLINE CHLORIDE OFLOXACIN, OFLOXACIN PROLENSA, BROMFENAC SODIUM RETISERT, FLUOCINOLONE ACETONIDE VITRASE, HYALURONIDASE ZIRGAN, 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 CROMOLYN SODIUM, CROMOLYN SODIUM (OTC) DESMOPRESSIN ACETATE, DESMOPRESSIN ACETATE FLUNISOLIDE, FLUNISOLIDE GENTAMICIN SULFATE, GENTAMICIN SULFATE IPRATROPIUM BROMIDE, IPRATROPIUM BROMIDE NEOMYCIN AND POLYMYXIN B SULFATES AND BACITRACIN ZINC, BACITRACIN ZINC NEOMYCIN AND POLYMYXIN B SULFATES AND GRAMICIDIN, GRAMICIDIN NEOMYCIN AND POLYMYXIN B SULFATES, BACITRACIN ZINC AND HYDROCORTISONE, BACITRACIN ZINC OFLOXACIN, OFLOXACIN OPTIPRANOLOL, METIPRANOLOL HYDROCHLORIDE PREDNISOLONE SODIUM PHOSPHATE, PREDNISOLONE SODIUM PHOSPHATE BAXTER HLTHCARE * BAXTER HEALTHCARE CORP BRANCHAMIN 4% IN PLASTIC CONTAINER, AMINO ACIDS BREVIBLOC DOUBLE STRENGTH IN PLASTIC CONTAINER, ESMOLOL HYDROCHLORIDE BREVIBLOC IN PLASTIC CONTAINER, ESMOLOL HYDROCHLORIDE BREVIBLOC, ESMOLOL HYDROCHLORIDE CEFEPIME IN PLASTIC CONTAINER, CEFEPIME HYDROCHLORIDE CEFTRIAXONE IN PLASTIC CONTAINER, CEFTRIAXONE SODIUM CLINIMIX 2.75/10 SULFITE FREE IN DEXTROSE 10% IN PLASTIC CONTAINER, AMINO ACIDS CLINIMIX E 2.75/5 SULFITE-FREE W/ ELECT IN DEXTROSE 5% W/ CALCIUM IN PLASTIC CONTAINER, CLINIMIX E 5/35 SULFITE-FREE W/ ELECT IN DEXTROSE 35% W/ CALCIUM IN PLASTIC CONTAINER, CLINISOL 15% SULFITE FREE IN PLASTIC CONTAINER, AMINO ACIDS CLINOLIPID 20%, OLIVE OIL CYCLOPHOSPHAMIDE, CYCLOPHOSPHAMIDE CYTOXAN (LYOPHILIZED), CYCLOPHOSPHAMIDE DEXTROSE 10% IN PLASTIC CONTAINER, DEXTROSE DEXTROSE 20% IN PLASTIC CONTAINER, DEXTROSE DEXTROSE 30% IN PLASTIC CONTAINER, DEXTROSE DECEMBER 2013 - APPROVED DRUG PRODUCT LIST APPENDIX B - PRODUCT NAME SORTED BY APPLICANT ** B ** * BAXTER HEALTHCARE CORP DEXTROSE 40% IN PLASTIC CONTAINER, DEXTROSE 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 DEXTROSE 5% IN PLASTIC CONTAINER, DEXTROSE DEXTROSE 50% IN PLASTIC CONTAINER, DEXTROSE DEXTROSE 60% IN PLASTIC CONTAINER, DEXTROSE DEXTROSE 70% IN PLASTIC CONTAINER, DEXTROSE 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 ETHRANE, ENFLURANE EXTRANEAL, ICODEXTRIN FAMOTIDINE PRESERVATIVE FREE IN PLASTIC CONTAINER, FAMOTIDINE FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, FLUCONAZOLE FORANE, ISOFLURANE HEPATASOL 8%, AMINO ACIDS IFEX, IFOSFAMIDE LACTATED RINGER'S IN PLASTIC CONTAINER, CALCIUM CHLORIDE MESNEX, MESNA MILRINONE LACTATE IN DEXTROSE 5% IN PLASTIC CONTAINER, MILRINONE LACTATE NEXTERONE, AMIODARONE HYDROCHLORIDE PLASMA-LYTE 148 AND DEXTROSE 5% IN PLASTIC CONTAINER, DEXTROSE 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 POTASSIUM CHLORIDE 0.15% IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, POTASSIUM POTASSIUM CHLORIDE 0.224% IN SODIUM CHLORIDE 0.9%, POTASSIUM CHLORIDE POTASSIUM CHLORIDE 0.3% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, POTASSIUM POTASSIUM CHLORIDE 10MEQ IN PLASTIC CONTAINER, POTASSIUM CHLORIDE POTASSIUM CHLORIDE 20MEQ IN PLASTIC CONTAINER, POTASSIUM CHLORIDE PREMASOL 10% IN PLASTIC CONTAINER, AMINO ACIDS PREMASOL 6% IN PLASTIC CONTAINER, AMINO ACIDS RENAMIN W/O ELECTROLYTES, AMINO ACIDS SEVOFLURANE, SEVOFLURANE SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, SODIUM CHLORIDE 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 SUPRANE, DESFLURANE TRAVASOL 10% IN PLASTIC CONTAINER, AMINO ACIDS TRAVASOL 10% W/O ELECTROLYTES, AMINO ACIDS TRAVASOL 5.5% IN PLASTIC CONTAINER, AMINO ACIDS TRAVASOL 5.5% W/O ELECTROLYTES, AMINO ACIDS TRAVASOL 8.5% IN PLASTIC CONTAINER, AMINO ACIDS TRAVASOL 8.5% W/O ELECTROLYTES, AMINO ACIDS VANCOCIN HYDROCHLORIDE IN PLASTIC CONTAINER, VANCOMYCIN HYDROCHLORIDE * BAXTER HEALTHCARE INTERNATI0NAL SPECIALTY THERAPIES DIV PROSOL 20% SULFITE FREE IN PLASTIC CONTAINER, AMINO ACIDS BAXTER HLTHCARE CORP * BAXTER HEALTHCARE CORP ANESTHESIA AND CRITICAL CARE PROTOPAM CHLORIDE, PRALIDOXIME CHLORIDE * BAXTER HEALTHCARE CORP ANESTHESIA CRITICAL CARE ATIVAN, LORAZEPAM OXYTOCIN, OXYTOCIN PROPRANOLOL HYDROCHLORIDE, PROPRANOLOL HYDROCHLORIDE REGLAN, METOCLOPRAMIDE HYDROCHLORIDE BAYER * BAYER HEALTHCARE LLC ALEVE-D SINUS & COLD, NAPROXEN SODIUM (OTC) FEMSTAT 3, BUTOCONAZOLE NITRATE (OTC) MYCELEX-7 COMBINATION PACK, CLOTRIMAZOLE (OTC) MYCELEX-7, CLOTRIMAZOLE (OTC) B - 21 DECEMBER 2013 - APPROVED DRUG PRODUCT LIST APPENDIX B - PRODUCT NAME SORTED BY APPLICANT ** B ** * BAYER HEALTHCARE LLC RID MOUSSE, PIPERONYL BUTOXIDE (OTC) BAYER HLTHCARE * BAYER HEALTHCARE PHARMACEUTICALS INC ADALAT CC, NIFEDIPINE ADEMPAS, RIOCIGUAT ANGELIQ, DROSPIRENONE AVELOX IN SODIUM CHLORIDE 0.8% IN PLASTIC CONTAINER, MOXIFLOXACIN HYDROCHLORIDE AVELOX, MOXIFLOXACIN HYDROCHLORIDE BEYAZ, DROSPIRENONE BILTRICIDE, PRAZIQUANTEL CIPRO IN DEXTROSE 5% IN PLASTIC CONTAINER, CIPROFLOXACIN CIPRO, CIPROFLOXACIN CIPRO, CIPROFLOXACIN HYDROCHLORIDE DESONATE, DESONIDE DTIC-DOME, DACARBAZINE EOVIST, GADOXETATE DISODIUM FINACEA, AZELAIC ACID GADAVIST, GADOBUTROL LEVITRA, VARDENAFIL HYDROCHLORIDE NATAZIA, DIENOGEST NEXAVAR, SORAFENIB TOSYLATE PRECOSE, ACARBOSE SAFYRAL, DROSPIRENONE SKYLA, LEVONORGESTREL STAXYN, VARDENAFIL HYDROCHLORIDE STIVARGA, REGORAFENIB ULTRAVIST 300 IN PLASTIC CONTAINER, IOPROMIDE XOFIGO, RADIUM RA-223 DICHLORIDE YASMIN, DROSPIRENONE YAZ, DROSPIRENONE BAYSHORE PHARMS LLC * BAYSHORE PHARMACEUTICALS LLC METHSCOPOLAMINE BROMIDE, METHSCOPOLAMINE BROMIDE BD RX * BD RX INC DIPHENHYDRAMINE HYDROCHLORIDE PRESERVATIVE FREE, DIPHENHYDRAMINE HYDROCHLORIDE METOCLOPRAMIDE HYDROCHLORIDE, METOCLOPRAMIDE HYDROCHLORIDE MORPHINE SULFATE, MORPHINE SULFATE ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE, ONDANSETRON HYDROCHLORIDE BECTON DICKINSON * BECTON DICKINSON AND CO CHLORHEXIDINE GLUCONATE, CHLORHEXIDINE GLUCONATE (OTC) BEDFORD * BEDFORD LABORATORIES DIV BEN VENUE LABORATORIES INC ADENOSINE, ADENOSINE AMIKACIN SULFATE, AMIKACIN SULFATE AMRINONE LACTATE, INAMRINONE LACTATE ATRACURIUM BESYLATE PRESERVATIVE FREE, ATRACURIUM BESYLATE ATRACURIUM BESYLATE, ATRACURIUM BESYLATE AZATHIOPRINE SODIUM, AZATHIOPRINE SODIUM AZTREONAM, AZTREONAM BLEOMYCIN SULFATE, BLEOMYCIN SULFATE BUMETANIDE, BUMETANIDE BUPRENORPHINE HYDROCHLORIDE, BUPRENORPHINE HYDROCHLORIDE CARBOPLATIN, CARBOPLATIN CEFTRIAXONE, CEFTRIAXONE SODIUM CISPLATIN, CISPLATIN CLINDAMYCIN PHOSPHATE, CLINDAMYCIN PHOSPHATE DACARBAZINE, DACARBAZINE DACTINOMYCIN, DACTINOMYCIN DEFEROXAMINE MESYLATE, DEFEROXAMINE MESYLATE DEXRAZOXANE HYDROCHLORIDE, DEXRAZOXANE HYDROCHLORIDE DICYCLOMINE HYDROCHLORIDE (PRESERVATIVE-FREE), DICYCLOMINE HYDROCHLORIDE DILTIAZEM HYDROCHLORIDE, DILTIAZEM HYDROCHLORIDE B - 22 DECEMBER 2013 - APPROVED DRUG PRODUCT LIST APPENDIX B - PRODUCT NAME SORTED BY APPLICANT ** B ** * BEDFORD LABORATORIES DIV BEN VENUE LABORATORIES INC DIPYRIDAMOLE, DIPYRIDAMOLE DOXAPRAM HYDROCHLORIDE, DOXAPRAM HYDROCHLORIDE DOXORUBICIN HYDROCHLORIDE, DOXORUBICIN HYDROCHLORIDE DOXYCYCLINE, DOXYCYCLINE HYCLATE ENALAPRILAT, ENALAPRILAT EPIRUBICIN HYDROCHLORIDE, EPIRUBICIN HYDROCHLORIDE 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, HALOPERIDOL LACTATE INDOMETHACIN SODIUM, INDOMETHACIN SODIUM KETOROLAC TROMETHAMINE, KETOROLAC TROMETHAMINE LEUCOVORIN CALCIUM PRESERVATIVE FREE, LEUCOVORIN CALCIUM LEUCOVORIN CALCIUM, LEUCOVORIN CALCIUM LEVOCARNITINE, LEVOCARNITINE MESNA, MESNA METHOTREXATE SODIUM PRESERVATIVE FREE, METHOTREXATE SODIUM METHOTREXATE SODIUM, METHOTREXATE SODIUM MILRINONE LACTATE, MILRINONE LACTATE 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 PROCHLORPERAZINE EDISYLATE, PROCHLORPERAZINE EDISYLATE RANITIDINE HYDROCHLORIDE, RANITIDINE HYDROCHLORIDE SUMATRIPTAN SUCCINATE, SUMATRIPTAN SUCCINATE TERBUTALINE SULFATE, TERBUTALINE SULFATE TESTOSTERONE CYPIONATE, TESTOSTERONE CYPIONATE 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 CAFCIT, CAFFEINE CITRATE 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 IFOSFAMIDE, IFOSFAMIDE IRINOTECAN HYDROCHLORIDE, IRINOTECAN HYDROCHLORIDE LORAZEPAM PRESERVATIVE FREE, LORAZEPAM MELPHALAN HYDROCHLORIDE, MELPHALAN HYDROCHLORIDE METOPROLOL TARTRATE, METOPROLOL TARTRATE MILRINONE LACTATE IN DEXTROSE 5% IN PLASTIC CONTAINER, MILRINONE LACTATE ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE, ONDANSETRON HYDROCHLORIDE ORPHENADRINE CITRATE, ORPHENADRINE CITRATE PENTOSTATIN, PENTOSTATIN TORSEMIDE, TORSEMIDE BELCHER PHARMS B - 23 DECEMBER 2013 - APPROVED DRUG PRODUCT LIST APPENDIX B - PRODUCT NAME SORTED BY APPLICANT ** B ** * BELCHER PHARMACEUTICALS LLC CEPHALEXIN, CEPHALEXIN DESLORATADINE, DESLORATADINE BEN VENUE * BEN VENUE LABORATORIES INC FAMOTIDINE PRESERVATIVE FREE, FAMOTIDINE RANITIDINE HYDROCHLORIDE, RANITIDINE HYDROCHLORIDE BEXIMCO USA * BEXIMCO PHARMACEUTICALS USA INC CARVEDILOL, CARVEDILOL BICON PHARM * BICON PHARMACEUTICAL INC FOLIC ACID, FOLIC ACID BIO NUCLEONICS * BIO NUCLEONICS INC STRONTIUM CHLORIDE SR-89, STRONTIUM CHLORIDE SR-89 BIO PHARM INC * BIO PHARM INC CETIRIZINE HYDROCHLORIDE, CETIRIZINE HYDROCHLORIDE CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY, CETIRIZINE HYDROCHLORIDE (OTC) CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF, CETIRIZINE HYDROCHLORIDE (OTC) RANITIDINE HYDROCHLORIDE, RANITIDINE HYDROCHLORIDE RISPERIDONE, RISPERIDONE BIOCODEX INC * BIOCODEX INC TOTECT, DEXRAZOXANE HYDROCHLORIDE BIOGEN IDEC INC * BIOGEN IDEC INC TECFIDERA, DIMETHYL FUMARATE BIOKEY * BIOKEY INC BENAZEPRIL HYDROCHLORIDE, BENAZEPRIL HYDROCHLORIDE CILOSTAZOL, CILOSTAZOL BIOMARIN PHARM * BIOMARIN PHARMACEUTICAL INC KUVAN, SAPROPTERIN DIHYDROCHLORIDE BLU CARIBE * BLU CARIBE INC GEMFIBROZIL, GEMFIBROZIL SIMVASTATIN, SIMVASTATIN BLU CARIBE INC * BLU CARIBE INC DOXYCYCLINE HYCLATE, DOXYCYCLINE HYCLATE BOEHRINGER INGELHEIM * BOEHRINGER INGELHEIM CATAPRES-TTS-1, CLONIDINE CATAPRES-TTS-2, CLONIDINE CATAPRES-TTS-3, CLONIDINE GILOTRIF, AFATINIB DIMALEATE 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 RESPIMAT, ALBUTEROL SULFATE FLOMAX, TAMSULOSIN HYDROCHLORIDE JENTADUETO, LINAGLIPTIN MIRAPEX ER, PRAMIPEXOLE DIHYDROCHLORIDE MOBIC, MELOXICAM B - 24 DECEMBER 2013 - APPROVED DRUG PRODUCT LIST APPENDIX B - PRODUCT NAME SORTED BY APPLICANT ** B ** * BOEHRINGER INGELHEIM PHARMACEUTICALS INC PERSANTINE, DIPYRIDAMOLE PRADAXA, DABIGATRAN ETEXILATE MESYLATE SPIRIVA, TIOTROPIUM BROMIDE MONOHYDRATE TRADJENTA, LINAGLIPTIN TWYNSTA, AMLODIPINE BESYLATE VIRAMUNE XR, NEVIRAPINE VIRAMUNE, NEVIRAPINE BRACCO * BRACCO DIAGNOSTICS INC CHOLETEC, TECHNETIUM TC-99M MEBROFENIN KIT CYSTOGRAFIN, DIATRIZOATE MEGLUMINE MULTIHANCE MULTIPACK, GADOBENATE DIMEGLUMINE MULTIHANCE, GADOBENATE DIMEGLUMINE PROHANCE MULTIPACK, GADOTERIDOL SINOGRAFIN, DIATRIZOATE MEGLUMINE BRAINTREE * BRAINTREE LABORATORIES INC AXID, NIZATIDINE GOLYTELY, POLYETHYLENE GLYCOL 3350 HALFLYTELY, BISACODYL NULYTELY, POLYETHYLENE GLYCOL 3350 NULYTELY-FLAVORED, POLYETHYLENE GLYCOL 3350 BRAINTREE LABS * BRAINTREE LABORATORIES INC SUCLEAR, MAGNESIUM SULFATE SUPREP BOWEL PREP KIT, MAGNESIUM SULFATE ANHYDROUS BRECKENRIDGE PHARM * BRECKENRIDGE PHARMACEUTICAL INC CETIRIZINE HYDROCHLORIDE, CETIRIZINE HYDROCHLORIDE CILOSTAZOL, CILOSTAZOL EPINASTINE HYDROCHLORIDE, EPINASTINE HYDROCHLORIDE ESTRADIOL AND NORETHINDRONE ACETATE, ESTRADIOL LEVETIRACETAM, LEVETIRACETAM MEFENAMIC ACID, MEFENAMIC ACID MELOXICAM, MELOXICAM METHSCOPOLAMINE BROMIDE, METHSCOPOLAMINE BROMIDE OXCARBAZEPINE, OXCARBAZEPINE POLYETHYLENE GLYCOL 3350, POLYETHYLENE GLYCOL 3350 PRAMIPEXOLE DIHYDROCHLORIDE, PRAMIPEXOLE DIHYDROCHLORIDE RANITIDINE HYDROCHLORIDE, RANITIDINE HYDROCHLORIDE TERBINAFINE HYDROCHLORIDE, TERBINAFINE HYDROCHLORIDE BRISTOL MYERS SQUIBB * BRISTOL MYERS SQUIBB AZACTAM, AZTREONAM BARACLUDE, ENTECAVIR GLUCOVANCE, GLYBURIDE KOMBIGLYZE XR, METFORMIN HYDROCHLORIDE LYSODREN, MITOTANE MEGACE, MEGESTROL ACETATE PRAVACHOL, PRAVASTATIN SODIUM * BRISTOL MYERS SQUIBB CO DROXIA, HYDROXYUREA GLUCOPHAGE XR, METFORMIN HYDROCHLORIDE IXEMPRA KIT, IXABEPILONE ONGLYZA, SAXAGLIPTIN HYDROCHLORIDE REYATAZ, ATAZANAVIR SULFATE SPRYCEL, DASATINIB SUSTIVA, EFAVIRENZ VIDEX EC, DIDANOSINE * BRISTOL MYERS SQUIBB CO PHARMACEUTICAL RESEARCH INSTITUTE ELIQUIS, APIXABAN GLUCOPHAGE, METFORMIN HYDROCHLORIDE VIDEX, DIDANOSINE ZERIT, STAVUDINE B - 25 DECEMBER 2013 - APPROVED DRUG PRODUCT LIST APPENDIX B - PRODUCT NAME SORTED BY APPLICANT ** B ** ** C ** BRYAN * BRYAN CORP TALC, TALC CADENCE PHARMS * CADENCE PHARMACEUTICALS INC OFIRMEV, ACETAMINOPHEN CADILA PHARMS LTD * CADILA PHARMACEUTICALS LTD ACYCLOVIR, ACYCLOVIR CADISTA PHARMS * CADISTA PHARMACEUTICALS INC ALENDRONATE SODIUM, ALENDRONATE SODIUM CETIRIZINE HYDROCHLORIDE ALLERGY, CETIRIZINE HYDROCHLORIDE (OTC) CETIRIZINE HYDROCHLORIDE HIVES, CETIRIZINE HYDROCHLORIDE (OTC) LAMOTRIGINE, LAMOTRIGINE LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE LOSARTAN POTASSIUM, LOSARTAN POTASSIUM OXCARBAZEPINE, OXCARBAZEPINE CARACO * CARACO PHARMACEUTICAL LABORATORIES LTD ALLOPURINOL, ALLOPURINOL AMITRIPTYLINE HYDROCHLORIDE, AMITRIPTYLINE HYDROCHLORIDE AMLODIPINE BESYLATE, AMLODIPINE BESYLATE ATENOLOL, ATENOLOL BACLOFEN, BACLOFEN BENZONATATE, BENZONATATE BETHANECHOL CHLORIDE, BETHANECHOL CHLORIDE CARVEDILOL, CARVEDILOL CETIRIZINE HYDROCHLORIDE ALLERGY, CETIRIZINE HYDROCHLORIDE (OTC) CETIRIZINE HYDROCHLORIDE HIVES RELIEF, 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) CITALOPRAM HYDROBROMIDE, CITALOPRAM HYDROBROMIDE CLONAZEPAM, CLONAZEPAM CLOZAPINE, CLOZAPINE ELIXOPHYLLIN, THEOPHYLLINE FLUMADINE, RIMANTADINE HYDROCHLORIDE FLURBIPROFEN, FLURBIPROFEN GEMFIBROZIL, GEMFIBROZIL GLIPIZIDE AND METFORMIN HYDROCHLORIDE, GLIPIZIDE GLIPIZIDE, GLIPIZIDE HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE HYDROCODONE BITARTRATE AND ACETAMINOPHEN, ACETAMINOPHEN HYDROXYZINE HYDROCHLORIDE, HYDROXYZINE HYDROCHLORIDE INDOMETHACIN, INDOMETHACIN ISOSORBIDE DINITRATE, ISOSORBIDE DINITRATE MELOXICAM, MELOXICAM MEPERIDINE HYDROCHLORIDE, MEPERIDINE HYDROCHLORIDE METFORMIN HYDROCHLORIDE, METFORMIN HYDROCHLORIDE METHIMAZOLE, METHIMAZOLE METHYLPHENIDATE HYDROCHLORIDE, METHYLPHENIDATE HYDROCHLORIDE METOPROLOL TARTRATE, METOPROLOL TARTRATE MINOCYCLINE HYDROCHLORIDE, MINOCYCLINE HYDROCHLORIDE MIRTAZAPINE, MIRTAZAPINE NITROFURANTOIN, NITROFURANTOIN OXAPROZIN, OXAPROZIN OXYCODONE AND ACETAMINOPHEN, ACETAMINOPHEN PAROMOMYCIN SULFATE, PAROMOMYCIN SULFATE PAROXETINE HYDROCHLORIDE, PAROXETINE HYDROCHLORIDE PHENTERMINE HYDROCHLORIDE, PHENTERMINE HYDROCHLORIDE PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE, CODEINE PHOSPHATE B - 26 DECEMBER 2013 - APPROVED DRUG PRODUCT LIST APPENDIX B - PRODUCT NAME SORTED BY APPLICANT ** C ** * CARACO PHARMACEUTICAL LABORATORIES LTD PROMETHAZINE HYDROCHLORIDE, PROMETHAZINE HYDROCHLORIDE RANITIDINE HYDROCHLORIDE, RANITIDINE HYDROCHLORIDE REPAGLINIDE, REPAGLINIDE 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 VERAPAMIL HYDROCHLORIDE, VERAPAMIL HYDROCHLORIDE ZOLPIDEM TARTRATE, ZOLPIDEM TARTRATE CARDINAL HEALTH 414 * CARDINAL HEALTH 414 LLC TECHNETIUM TC 99M SESTAMIBI, TECHNETIUM TC-99M SESTAMIBI KIT * CARDINAL HEALTH 414 LLC CARDINAL HEALTH NUCLEAR PHARMACY SERVICES AMMONIA N 13, AMMONIA N-13 CARDINAL HLTH 414 * CARDINAL HEALTH 414 SODIUM IODIDE I 123, SODIUM IODIDE I-123 CAREFUSION * CAREFUSION 213 LLC CHLORAPREP ONE-STEP FREPP, CHLORHEXIDINE GLUCONATE (OTC) CHLORAPREP ONE-STEP SEPP, CHLORHEXIDINE GLUCONATE (OTC) CHLORAPREP ONE-STEP, CHLORHEXIDINE GLUCONATE (OTC) CHLORAPREP SINGLE SWABSTICK, CHLORHEXIDINE GLUCONATE (OTC) CHLORAPREP TRIPLE SWABSTICK, CHLORHEXIDINE GLUCONATE (OTC) CHLORAPREP WITH TINT, CHLORHEXIDINE GLUCONATE (OTC) PHARMASEAL SCRUB CARE, CHLORHEXIDINE GLUCONATE (OTC) CARLSBAD * CARLSBAD TECHNOLOGY INC CIPROFLOXACIN HYDROCHLORIDE, CIPROFLOXACIN HYDROCHLORIDE CLONIDINE HYDROCHLORIDE, CLONIDINE HYDROCHLORIDE FAMOTIDINE, FAMOTIDINE GLIMEPIRIDE, GLIMEPIRIDE LOVASTATIN, LOVASTATIN MELOXICAM, MELOXICAM MODAFINIL, MODAFINIL ZOLPIDEM TARTRATE, ZOLPIDEM TARTRATE CAROLINA MEDCL * CAROLINA MEDICAL PRODUCTS CO AMANTADINE HYDROCHLORIDE, AMANTADINE HYDROCHLORIDE ISONIAZID, ISONIAZID SPS, SODIUM POLYSTYRENE SULFONATE CATALENT * CATALENT PHARMA SOLUTIONS LLC VALPROIC ACID, VALPROIC ACID CEDAR PHARMS * CEDAR PHARMACEUTICALS LLC METHIMAZOLE, METHIMAZOLE SODIUM POLYSTYRENE SULFONATE, SODIUM POLYSTYRENE SULFONATE CELGENE * CELGENE CORP ISTODAX, ROMIDEPSIN POMALYST, POMALIDOMIDE REVLIMID, LENALIDOMIDE THALOMID, THALIDOMIDE VIDAZA, AZACITIDINE CEPHALON * CEPHALON INC ACTIQ, FENTANYL CITRATE FENTORA, FENTANYL CITRATE GABITRIL, TIAGABINE HYDROCHLORIDE NUVIGIL, ARMODAFINIL B - 27 DECEMBER 2013 - APPROVED DRUG PRODUCT LIST APPENDIX B - PRODUCT NAME SORTED BY APPLICANT ** C ** * CEPHALON INC PROVIGIL, MODAFINIL TREANDA, BENDAMUSTINE HYDROCHLORIDE TRISENOX, ARSENIC TRIOXIDE CEREXA * CEREXA INC TEFLARO, CEFTAROLINE FOSAMIL CHARTWELL LIFE SCI * CHARTWELL LIFE SCIENCE LLC DOXYCYCLINE HYCLATE, DOXYCYCLINE HYCLATE DOXYCYCLINE, DOXYCYCLINE METFORMIN HYDROCHLORIDE, METFORMIN HYDROCHLORIDE 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 CONZIP, TRAMADOL HYDROCHLORIDE LIPOFEN, FENOFIBRATE CIPLA * CIPLA LTD NEVIRAPINE, NEVIRAPINE RISPERIDONE, RISPERIDONE ZIDOVUDINE, ZIDOVUDINE CIPLA LTD * CIPLA LTD ALBUTEROL SULFATE AND IPRATROPIUM BROMIDE, ALBUTEROL SULFATE ALENDRONATE SODIUM, ALENDRONATE SODIUM AMLODIPINE BESYLATE, AMLODIPINE BESYLATE CARBOPLATIN, CARBOPLATIN CARVEDILOL, CARVEDILOL CETIRIZINE HYDROCHLORIDE ALLERGY, CETIRIZINE HYDROCHLORIDE (OTC) CICLOPIROX, CICLOPIROX CITALOPRAM HYDROBROMIDE, CITALOPRAM HYDROBROMIDE DONEPEZIL HYDROCHLORIDE, DONEPEZIL HYDROCHLORIDE EPIRUBICIN HYDROCHLORIDE, EPIRUBICIN HYDROCHLORIDE FAMCICLOVIR, FAMCICLOVIR GEMCITABINE HYDROCHLORIDE, GEMCITABINE HYDROCHLORIDE GRANISETRON HYDROCHLORIDE, GRANISETRON HYDROCHLORIDE IRBESARTAN, IRBESARTAN IRINOTECAN HYDROCHLORIDE, IRINOTECAN HYDROCHLORIDE LAMOTRIGINE, LAMOTRIGINE LEVALBUTEROL HYDROCHLORIDE, LEVALBUTEROL HYDROCHLORIDE LEVOFLOXACIN, LEVOFLOXACIN MELOXICAM, MELOXICAM PRAVASTATIN SODIUM, PRAVASTATIN SODIUM RIZATRIPTAN BENZOATE, RIZATRIPTAN BENZOATE STAVUDINE, STAVUDINE TERBINAFINE HYDROCHLORIDE, TERBINAFINE HYDROCHLORIDE TOPIRAMATE, TOPIRAMATE ZALEPLON, ZALEPLON ZIDOVUDINE, ZIDOVUDINE ZOLPIDEM TARTRATE, ZOLPIDEM TARTRATE CITIUS PHARMS * CITIUS PHARMACEUTICALS LLC SUPRENZA, PHENTERMINE HYDROCHLORIDE CITRON PHARMA LLC B - 28 DECEMBER 2013 - APPROVED DRUG PRODUCT LIST APPENDIX B - PRODUCT NAME SORTED BY APPLICANT ** C ** * CITRON PHARMA LLC ANTIVERT, MECLIZINE HYDROCHLORIDE CORTISPORIN, HYDROCORTISONE THALITONE, CHLORTHALIDONE CLARIS LIFESCIENCES * CLARIS LIFESCIENCES LIMITED ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE, ONDANSETRON HYDROCHLORIDE ONDANSETRON HYDROCHLORIDE, ONDANSETRON HYDROCHLORIDE * CLARIS LIFESCIENCES LTD CIPROFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER, CIPROFLOXACIN CIPROFLOXACIN, CIPROFLOXACIN FLUCONAZOLE IN DEXTROSE 5% IN PLASTIC CONTAINER, FLUCONAZOLE FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, FLUCONAZOLE FLUCONAZOLE IN SODIUM CHLORIDE 0.9%, FLUCONAZOLE LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER, LEVOFLOXACIN LEVOFLOXACIN, LEVOFLOXACIN METOPROLOL TARTRATE, METOPROLOL TARTRATE METRONIDAZOLE IN PLASTIC CONTAINER, METRONIDAZOLE NOREPINEPHRINE BITARTRATE, NOREPINEPHRINE BITARTRATE CLINIGEN HLTHCARE * CLINIGEN HEALTHCARE LTD FOSCAVIR, FOSCARNET SODIUM CLONMEL HLTHCARE * CLONMEL HEALTHCARE LTD MORPHINE SULFATE, MORPHINE SULFATE CLOVER PHARMS * CLOVER PHARMACEUTICALS CORP AMICAR, AMINOCAPROIC ACID CNTY LINE PHARMS * COUNTY LINE PHARMACEUTICALS LLC UREX, METHENAMINE HIPPURATE COASTAL PHARMS * COASTAL PHARMACEUTICALS BROMFENAC SODIUM, BROMFENAC SODIUM LIOTHYRONINE SODIUM, LIOTHYRONINE SODIUM METHAMPHETAMINE HYDROCHLORIDE, METHAMPHETAMINE HYDROCHLORIDE NYSTATIN, NYSTATIN OXYCODONE AND ACETAMINOPHEN, ACETAMINOPHEN OXYCODONE AND ASPIRIN, ASPIRIN OXYCODONE HYDROCHLORIDE, OXYCODONE HYDROCHLORIDE CONCORDIA PHARMS INC * CONCORDIA PHARMACEUTICALS INC KAPVAY, CLONIDINE HYDROCHLORIDE ORAPRED ODT, PREDNISOLONE SODIUM PHOSPHATE ORAPRED, PREDNISOLONE SODIUM PHOSPHATE CONTRACT PHARMACAL * CONTRACT PHARMACAL CORP CETIRIZINE HYDROCHLORIDE ALLERGY, CETIRIZINE HYDROCHLORIDE (OTC) 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) CORCEPT THERAP * CORCEPT THERAPEUTICS INC KORLYM, MIFEPRISTONE CORDEN PHARMA * CORDEN PHARMA LATINA SPA CEENU, LOMUSTINE B - 29 DECEMBER 2013 - APPROVED DRUG PRODUCT LIST APPENDIX B - B - 30 PRODUCT NAME SORTED BY APPLICANT ** C ** COREPHARMA * COREPHARMA LLC ALPRAZOLAM, ALPRAZOLAM BENZTROPINE MESYLATE, BENZTROPINE MESYLATE CLINDAMYCIN HYDROCHLORIDE, CLINDAMYCIN HYDROCHLORIDE CYPROHEPTADINE HYDROCHLORIDE, CYPROHEPTADINE HYDROCHLORIDE DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE, AMPHETAMINE DIETHYLPROPION HYDROCHLORIDE, DIETHYLPROPION HYDROCHLORIDE DOXYCYCLINE HYCLATE, DOXYCYCLINE HYCLATE GLIPIZIDE AND METFORMIN HYDROCHLORIDE, GLIPIZIDE GLYBURIDE AND METFORMIN HYDROCHLORIDE, GLYBURIDE GLYBURIDE, GLYBURIDE GRANISETRON HYDROCHLORIDE, GRANISETRON HYDROCHLORIDE ISOSORBIDE DINITRATE, ISOSORBIDE DINITRATE LEVOCARNITINE, LEVOCARNITINE METHENAMINE HIPPURATE, METHENAMINE HIPPURATE OXYCODONE HYDROCHLORIDE, OXYCODONE HYDROCHLORIDE PILOCARPINE HYDROCHLORIDE, PILOCARPINE HYDROCHLORIDE POTASSIUM CITRATE, POTASSIUM CITRATE TIZANIDINE HYDROCHLORIDE, TIZANIDINE HYDROCHLORIDE TRANDOLAPRIL, TRANDOLAPRIL URSODIOL, URSODIOL CORNERSTONE THERAP * CORNERSTONE THERAPEUTICS INC BETHKIS, TOBRAMYCIN CUROSURF, PORACTANT ALFA HYDROCODONE POLISTIREX AND CHLORPHENIRAMNE POLISTIREX, CHLORPHENIRAMINE POLISTIREX ZYFLO CR, ZILEUTON ZYFLO, ZILEUTON COVIDIEN * COVIDIEN LYMPHAZURIN, ISOSULFAN BLUE COVIS PHARMA * COVIS PHARMA SARL FORTAZ IN PLASTIC CONTAINER, CEFTAZIDIME SODIUM FORTAZ, CEFTAZIDIME LANOXIN PEDIATRIC, DIGOXIN LANOXIN, DIGOXIN PARNATE, TRANYLCYPROMINE SULFATE ZANTAC, RANITIDINE HYDROCHLORIDE ZINACEF IN PLASTIC CONTAINER, CEFUROXIME SODIUM ZINACEF, CEFUROXIME SODIUM COVIS PHARMA SARL * COVIS PHARMA SARL KAYEXALATE, SODIUM POLYSTYRENE SULFONATE NILANDRON, NILUTAMIDE RILUTEK, RILUZOLE UROXATRAL, ALFUZOSIN HYDROCHLORIDE CPPI CV * CP PHARMACEUTICALS INTERNATIONAL CV SUTENT, SUNITINIB MALATE CREALTA PHARMS LLC * CREALTA PHARMACEUTICALS LLC MIGERGOT, CAFFEINE CROWN LABS * CROWN LABORATORIES INC ALA-CORT, HYDROCORTISONE ALA-SCALP, HYDROCORTISONE TRIDERM, TRIAMCINOLONE ACETONIDE CSL BEHRING * CSL BEHRING LLC STIMATE (NEEDS NO REFRIGERATION), DESMOPRESSIN ACETATE CSPC OUYI PHARM CO * CSPC OUYI PHARMACEUTICAL CO LTD DECEMBER 2013 - APPROVED DRUG PRODUCT LIST APPENDIX B - PRODUCT NAME SORTED BY APPLICANT ** C ** * CSPC OUYI PHARMACEUTICAL CO LTD METFORMIN HYDROCHLORIDE, METFORMIN HYDROCHLORIDE TRAMADOL HYDROCHLORIDE, TRAMADOL HYDROCHLORIDE CUBIST * CUBIST PHARMACEUTICALS INC CUBICIN, DAPTOMYCIN CUBIST PHARMS * CUBIST PHARMACEUTICALS INC ENTEREG, ALVIMOPAN CUMBERLAND PHARMS * CUMBERLAND PHARMACEUTICALS INC ACETADOTE, ACETYLCYSTEINE CALDOLOR, IBUPROFEN LACTULOSE, LACTULOSE CYPRESS BIOSCIENCE * CYPRESS BIOSCIENCE INC SAVELLA, MILNACIPRAN HYDROCHLORIDE CYPRESS PHARM * CYPRESS PHARMACEUTICAL INC CARBINOXAMINE MALEATE, CARBINOXAMINE MALEATE CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY, CETIRIZINE HYDROCHLORIDE (OTC) CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF, CETIRIZINE HYDROCHLORIDE (OTC) ELIPHOS, CALCIUM ACETATE REZIRA, HYDROCODONE BITARTRATE VITUZ, CHLORPHENIRAMINE MALEATE ZUTRIPRO, CHLORPHENIRAMINE MALEATE ** D ** DAIICHI * DAIICHI PHARMACEUTICAL CORP FLOXIN OTIC, OFLOXACIN DAIICHI SANKYO * DAIICHI SANKYO INC AZOR, AMLODIPINE BESYLATE EVOXAC, CEVIMELINE HYDROCHLORIDE TRIBENZOR, AMLODIPINE BESYLATE WELCHOL, COLESEVELAM HYDROCHLORIDE DANCO LABS LLC * DANCO LABORATORIES LLC MIFEPREX, MIFEPRISTONE DARA BIOSCIENCES * DARA BIOSCIENCES INC SOLTAMOX, TAMOXIFEN CITRATE DAVA INTL INC * DAVA INTERNATIONAL INC ALPRAZOLAM, ALPRAZOLAM 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 DOXAZOSIN MESYLATE, DOXAZOSIN MESYLATE GEMFIBROZIL, GEMFIBROZIL GLYBURIDE (MICRONIZED), GLYBURIDE HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE METHOTREXATE SODIUM, METHOTREXATE SODIUM NAPROXEN, NAPROXEN PENICILLIN V POTASSIUM, PENICILLIN V POTASSIUM PROPYLTHIOURACIL, PROPYLTHIOURACIL B - 31 DECEMBER 2013 - APPROVED DRUG PRODUCT LIST APPENDIX B - PRODUCT NAME SORTED BY APPLICANT ** D ** * DAVA PHARMACEUTICALS INC PYRAZINAMIDE, PYRAZINAMIDE SELEGILINE HYDROCHLORIDE, SELEGILINE HYDROCHLORIDE VOSPIRE ER, ALBUTEROL SULFATE DELCOR ASSET * DELCOR ASSET CORP EVOCLIN, CLINDAMYCIN PHOSPHATE LUXIQ, BETAMETHASONE VALERATE OLUX E, CLOBETASOL PROPIONATE ZOVIRAX, ACYCLOVIR DELCOR ASSET CORP * DELCOR ASSET CORP ERYGEL, ERYTHROMYCIN DENCO ASSET * DENCO ASSET LLC DENAVIR, PENCICLOVIR SODIUM DENTSPLY PHARM * DENTSPLY PHARMACEUTICAL INC CITANEST FORTE DENTAL, EPINEPHRINE BITARTRATE ORAQIX, LIDOCAINE DEPOMED INC * DEPOMED INC GRALISE, GABAPENTIN LAZANDA, FENTANYL CITRATE ZIPSOR, DICLOFENAC POTASSIUM DEPROCO * DEPROCO INC SCANDONEST L, LEVONORDEFRIN SCANDONEST PLAIN, MEPIVACAINE HYDROCHLORIDE SEPTOCAINE, ARTICAINE HYDROCHLORIDE DEXCEL LTD * DEXCEL LTD DICLOFENAC SODIUM, DICLOFENAC SODIUM DEXCEL PHARMA * DEXCEL PHARMA TECHNOLOGIES LTD OMEPRAZOLE, OMEPRAZOLE (OTC) PERIOCHIP, CHLORHEXIDINE GLUCONATE DEY * DEY LP ACCUNEB, ALBUTEROL SULFATE DUONEB, ALBUTEROL SULFATE IPRATROPIUM BROMIDE, IPRATROPIUM BROMIDE LEVALBUTEROL HYDROCHLORIDE, LEVALBUTEROL HYDROCHLORIDE METAPROTERENOL SULFATE, METAPROTERENOL SULFATE DIALYSIS SUPS * DIALYSIS SUPPLIES INC NORMOCARB HF 25, MAGNESIUM CHLORIDE NORMOCARB HF 35, MAGNESIUM CHLORIDE DIGESTIVE CARE INC * DIGESTIVE CARE INC PERTZYE, PANCRELIPASE (AMYLASE DISCOVERY LABS * DISCOVERY LABORATORIES INC SURFAXIN, LUCINACTANT DORADO PHARMA * DORADO PHARMA LLC KETOPROFEN, KETOPROFEN DORC * DORC INTERNATIONAL BV MEMBRANEBLUE, TRYPAN BLUE VISIONBLUE, TRYPAN BLUE DOUGLAS PHARMS * DOUGLAS PHARMACEUTICALS AMERICA LTD MYORISAN, ISOTRETINOIN B - 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33 DECEMBER 2013 - APPROVED DRUG PRODUCT LIST APPENDIX B - PRODUCT NAME SORTED BY APPLICANT ** D ** * DR REDDYS LABORATORIES LTD CITALOPRAM HYDROBROMIDE, CITALOPRAM HYDROBROMIDE CLOPIDOGREL BISULFATE, CLOPIDOGREL BISULFATE DECITABINE, DECITABINE DESLORATADINE AND PSEUDOEPHEDRINE SULFATE 24 HOUR, DESLORATADINE DESLORATADINE, DESLORATADINE DIVALPROEX SODIUM, DIVALPROEX SODIUM DONEPEZIL HYDROCHLORIDE, DONEPEZIL HYDROCHLORIDE DULOXETINE HYDROCHLORIDE, DULOXETINE HYDROCHLORIDE ENALAPRIL MALEATE AND HYDROCHLOROTHIAZIDE, ENALAPRIL MALEATE FAMOTIDINE, FAMOTIDINE FAMOTIDINE, FAMOTIDINE (OTC) FEXOFENADINE HYDROCHLORIDE ALLERGY, FEXOFENADINE HYDROCHLORIDE (OTC) FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE, FEXOFENADINE FEXOFENADINE HYDROCHLORIDE HIVES, FEXOFENADINE HYDROCHLORIDE (OTC) FEXOFENADINE HYDROCHLORIDE, FEXOFENADINE HYDROCHLORIDE FINASTERIDE, FINASTERIDE FLUOXETINE HYDROCHLORIDE, FLUOXETINE HYDROCHLORIDE FONDAPARINUX SODIUM, FONDAPARINUX SODIUM GALANTAMINE HYDROBROMIDE, GALANTAMINE HYDROBROMIDE GEMCITABINE HYDROCHLORIDE, GEMCITABINE HYDROCHLORIDE GLIMEPIRIDE, GLIMEPIRIDE GLYCOPYRROLATE, GLYCOPYRROLATE GRANISETRON HYDROCHLORIDE, GRANISETRON HYDROCHLORIDE IBANDRONATE SODIUM, IBANDRONATE SODIUM IBUPROFEN AND DIPHENHYDRAMINE CITRATE, DIPHENHYDRAMINE CITRATE (OTC) IBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE, IBUPROFEN (OTC) IRBESARTAN AND HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE IRBESARTAN, IRBESARTAN IRINOTECAN HYDROCHLORIDE, IRINOTECAN HYDROCHLORIDE LAMOTRIGINE, LAMOTRIGINE LANSOPRAZOLE, LANSOPRAZOLE LANSOPRAZOLE, LANSOPRAZOLE (OTC) LATANOPROST, LATANOPROST LETROZOLE, LETROZOLE LEVETIRACETAM, LEVETIRACETAM METOPROLOL SUCCINATE, METOPROLOL SUCCINATE MINOCYCLINE HYDROCHLORIDE, MINOCYCLINE HYDROCHLORIDE MONTELUKAST SODIUM, MONTELUKAST SODIUM MYCOPHENOLATE MOFETIL, MYCOPHENOLATE MOFETIL NAPROXEN AND ESOMEPRAZOLE MAGNESIUM, ESOMEPRAZOLE MAGNESIUM NAPROXEN SODIUM, NAPROXEN SODIUM NATEGLINIDE, NATEGLINIDE NIZATIDINE, NIZATIDINE OFLOXACIN, OFLOXACIN OLANZAPINE, OLANZAPINE OMEPRAZOLE MAGNESIUM, OMEPRAZOLE MAGNESIUM (OTC) OMEPRAZOLE, OMEPRAZOLE ONDANSETRON HYDROCHLORIDE, ONDANSETRON HYDROCHLORIDE OXAPROZIN, OXAPROZIN PANTOPRAZOLE SODIUM, PANTOPRAZOLE SODIUM PIOGLITAZONE HYDROCHLORIDE, PIOGLITAZONE HYDROCHLORIDE QUETIAPINE FUMARATE, QUETIAPINE FUMARATE RABEPRAZOLE SODIUM, RABEPRAZOLE SODIUM RAMIPRIL, RAMIPRIL RANITIDINE HYDROCHLORIDE, RANITIDINE HYDROCHLORIDE RANITIDINE HYDROCHLORIDE, RANITIDINE HYDROCHLORIDE (OTC) RISPERIDONE, RISPERIDONE ROPINIROLE HYDROCHLORIDE, ROPINIROLE HYDROCHLORIDE SILDENAFIL CITRATE, SILDENAFIL CITRATE TACROLIMUS, TACROLIMUS TOPOTECAN HYDROCHLORIDE, TOPOTECAN HYDROCHLORIDE VALACYCLOVIR HYDROCHLORIDE, VALACYCLOVIR HYDROCHLORIDE VENLAFAXINE HYDROCHLORIDE, VENLAFAXINE HYDROCHLORIDE VINORELBINE TARTRATE, VINORELBINE TARTRATE B - 34 DECEMBER 2013 - APPROVED DRUG PRODUCT LIST APPENDIX B - PRODUCT NAME SORTED BY APPLICANT ** D ** * DR REDDYS LABORATORIES LTD ZAFIRLUKAST, ZAFIRLUKAST ZENATANE, ISOTRETINOIN ZOLEDRONIC ACID, ZOLEDRONIC ACID DR REDDYS LABS SA * DR REDDYS LABORATORIES SA FENOFIBRATE (MICRONIZED), FENOFIBRATE DRAXIMAGE * DRAXIMAGE INC TECHNETIUM TC 99M SESTAMIBI, TECHNETIUM TC-99M SESTAMIBI KIT DSM PHARMS INC * DSM PHARMACEUTICALS INC GRANISETRON HYDROCHLORIDE PRESERVATIVE FREE, GRANISETRON HYDROCHLORIDE GRANISETRON HYDROCHLORIDE, GRANISETRON HYDROCHLORIDE DUCHESNAY * DUCHESNAY INC DICLEGIS, DOXYLAMINE SUCCINATE DURAMED PHARMS BARR * DURAMED PHARMACEUTICALS INC SUB BARR LABORATORIES INC AVIANE-28, ETHINYL ESTRADIOL DIAMOX, ACETAZOLAMIDE ENPRESSE-28, ETHINYL ESTRADIOL VELIVET, DESOGESTREL DURAMED RES * DURAMED RESEARCH INC AYGESTIN, NORETHINDRONE ACETATE REDDYS * DOCTOR REDDYS LABORATORIES LTD DESLORATADINE, DESLORATADINE DIVALPROEX SODIUM, DIVALPROEX SODIUM METOPROLOL SUCCINATE, METOPROLOL SUCCINATE ** E ** EAGLE PHARMS * EAGLE PHARMACEUTICALS INC ARGATROBAN IN SODIUM CHLORIDE, ARGATROBAN EBEWE PHARMA * EBEWE PHARMA GRANISETRON HYDROCHLORIDE, GRANISETRON HYDROCHLORIDE * EBEWE PHARMA GES MBH NFG KG CARBOPLATIN, CARBOPLATIN EPIRUBICIN HYDROCHLORIDE, EPIRUBICIN HYDROCHLORIDE FLUOROURACIL, FLUOROURACIL IRINOTECAN HYDROCHLORIDE, IRINOTECAN HYDROCHLORIDE METHOTREXATE SODIUM PRESERVATIVE FREE, METHOTREXATE SODIUM OXALIPLATIN, OXALIPLATIN PACLITAXEL, PACLITAXEL VINORELBINE TARTRATE, VINORELBINE TARTRATE ECLAT PHARMS LLC * ECLAT PHARMACEUTICALS LLC BLOXIVERZ, NEOSTIGMINE METHYLSULFATE ECR * ECR PHARMACEUTICALS DEXAMETHASONE, DEXAMETHASONE EDGEMONT PHARMS LLC * EDGEMONT PHARMACEUTICALS LLC FLUOXETINE HYDROCHLORIDE, FLUOXETINE HYDROCHLORIDE FORFIVO XL, BUPROPION HYDROCHLORIDE EI INC * EI INC THEROXIDIL, MINOXIDIL (OTC) EISAI INC * EISAI INC ACIPHEX SPRINKLE, RABEPRAZOLE SODIUM B - 35 DECEMBER 2013 - APPROVED DRUG PRODUCT LIST APPENDIX B - PRODUCT NAME SORTED BY APPLICANT ** E ** * EISAI INC ACIPHEX, RABEPRAZOLE SODIUM ARICEPT ODT, DONEPEZIL HYDROCHLORIDE ARICEPT, DONEPEZIL HYDROCHLORIDE BANZEL, RUFINAMIDE BELVIQ, LORCASERIN HYDROCHLORIDE DACOGEN, DECITABINE FRAGMIN, DALTEPARIN SODIUM FYCOMPA, PERAMPANEL HALAVEN, ERIBULIN MESYLATE HEXALEN, ALTRETAMINE PANRETIN, ALITRETINOIN SALAGEN, PILOCARPINE HYDROCHLORIDE 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 ELI LILLY AND CO * ELI LILLY AND CO AXIRON, TESTOSTERONE EFFIENT, PRASUGREL HYDROCHLORIDE PROZAC, FLUOXETINE HYDROCHLORIDE SARAFEM, FLUOXETINE HYDROCHLORIDE ELI LILLY CO * ELI LILLY CO ADCIRCA, TADALAFIL ZYPREXA RELPREVV, OLANZAPINE PAMOATE ELITE LABS * ELITE LABORATORIES INC HYDROMORPHONE HYDROCHLORIDE, HYDROMORPHONE HYDROCHLORIDE NALTREXONE HYDROCHLORIDE, NALTREXONE HYDROCHLORIDE PHENTERMINE HYDROCHLORIDE, PHENTERMINE HYDROCHLORIDE EMCURE PHARMS * EMCURE PHARMACEUTICALS LTD ONDANSETRON HYDROCHLORIDE, ONDANSETRON HYDROCHLORIDE EMCURE PHARMS INDIA * EMCURE PHARMACEUTICALS LTD INDIA FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE, FOSINOPRIL EMCURE PHARMS LTD * EMCURE PHARMACEUTICALS LTD ACARBOSE, ACARBOSE AMIKACIN SULFATE, AMIKACIN SULFATE BENZPHETAMINE HYDROCHLORIDE, BENZPHETAMINE HYDROCHLORIDE BICNU, CARMUSTINE CIDOFOVIR, CIDOFOVIR COLISTIMETHATE SODIUM, COLISTIMETHATE SODIUM GEMCITABINE HYDROCHLORIDE, GEMCITABINE HYDROCHLORIDE IRINOTECAN HYDROCHLORIDE, IRINOTECAN HYDROCHLORIDE LEVOFLOXACIN, LEVOFLOXACIN METOCLOPRAMIDE, METOCLOPRAMIDE HYDROCHLORIDE ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE, ONDANSETRON HYDROCHLORIDE PROCHLORPERAZINE EDISYLATE, PROCHLORPERAZINE EDISYLATE RIZATRIPTAN BENZOATE, RIZATRIPTAN BENZOATE VANCOMYCIN HYDROCHLORIDE, VANCOMYCIN HYDROCHLORIDE ZOLEDRONIC ACID, ZOLEDRONIC ACID EMCURE PHARMS USA * EMCURE PHARMACEUTICALS USA INC DIFLUNISAL, DIFLUNISAL HYDROXYZINE PAMOATE, HYDROXYZINE PAMOATE METHIMAZOLE, METHIMAZOLE B - 36 DECEMBER 2013 - APPROVED DRUG PRODUCT LIST APPENDIX B - PRODUCT NAME SORTED BY APPLICANT ** E ** * EMCURE PHARMACEUTICALS USA INC NIFEDIPINE, NIFEDIPINE POLYETHYLENE GLYCOL 3350, POLYETHYLENE GLYCOL 3350 (OTC) PROMETHAZINE HYDROCHLORIDE, PROMETHAZINE HYDROCHLORIDE EMCURE USA * EMCURE PHARMACEUTICALS USA INC BETHANECHOL CHLORIDE, BETHANECHOL CHLORIDE EMD SERONO * EMD SERONO INC EGRIFTA, TESAMORELIN ACETATE GONAL-F RFF PEN, FOLLITROPIN ALFA/BETA GONAL-F RFF, FOLLITROPIN ALFA/BETA GONAL-F, FOLLITROPIN ALFA/BETA OVIDREL, CHORIOGONADOTROPIN ALFA SAIZEN, SOMATROPIN RECOMBINANT SEROPHENE, CLOMIPHENE CITRATE SEROSTIM, SOMATROPIN RECOMBINANT ZORBTIVE, SOMATROPIN RECOMBINANT EMD SERONO INC * EMD SERONO INC CETROTIDE, CETRORELIX EMMAUS MEDCL * EMMAUS MEDICAL INC NUTRESTORE, GLUTAMINE ENDO PHARM * ENDO PHARMACEUTICAL SOLUTIONS INC SUPPRELIN LA, HISTRELIN ACETATE VALSTAR PRESERVATIVE FREE, VALRUBICIN VANTAS, HISTRELIN ACETATE ENDO PHARMS * ENDO PHARMACEUTICALS INC DELATESTRYL, TESTOSTERONE ENANTHATE FORTESTA, TESTOSTERONE FROVA, FROVATRIPTAN SUCCINATE OPANA ER, OXYMORPHONE HYDROCHLORIDE OPANA, OXYMORPHONE HYDROCHLORIDE PERCODAN, ASPIRIN EPIC PHARMA * EPIC PHARMA INC MEPERIDINE HYDROCHLORIDE, MEPERIDINE HYDROCHLORIDE NICARDIPINE HYDROCHLORIDE, NICARDIPINE HYDROCHLORIDE * EPIC PHARMA LLC BETAXOLOL HYDROCHLORIDE, BETAXOLOL HYDROCHLORIDE CITALOPRAM HYDROBROMIDE, CITALOPRAM HYDROBROMIDE FLAVOXATE HYDROCHLORIDE, FLAVOXATE HYDROCHLORIDE SULINDAC, SULINDAC TRANDOLAPRIL, TRANDOLAPRIL URSODIOL, URSODIOL EPIC PHARMA INC * EPIC PHARMA INC SOTALOL HYDROCHLORIDE, SOTALOL HYDROCHLORIDE EPIC PHARMA LLC * EPIC PHARMA LLC AMLODIPINE BESYLATE, AMLODIPINE BESYLATE GUANFACINE HYDROCHLORIDE, GUANFACINE HYDROCHLORIDE MECLIZINE HYDROCHLORIDE, MECLIZINE HYDROCHLORIDE PROTRIPTYLINE HYDROCHLORIDE, PROTRIPTYLINE HYDROCHLORIDE ERGOJECT * ERGOJECT LLC METHYLERGONOVINE MALEATE, METHYLERGONOVINE MALEATE ETHYPHARM * ETHYPHARM BUPRENORPHINE HYDROCHLORIDE, BUPRENORPHINE HYDROCHLORIDE EURAND B - 37 DECEMBER 2013 - APPROVED DRUG PRODUCT LIST APPENDIX B - PRODUCT NAME SORTED BY APPLICANT ** E ** * EURAND AMERICA INC POTASSIUM CHLORIDE, POTASSIUM CHLORIDE EXALENZ BIOSCIENCE * EXALENZ BIOSCIENCE LTD IDKIT:HP, CITRIC ACID EXCELLIUM * EXCELLIUM PHARMACEUTICAL INC BENZTROPINE MESYLATE, BENZTROPINE MESYLATE FOLIC ACID, FOLIC ACID FUROSEMIDE, FUROSEMIDE GLYCOPYRROLATE, GLYCOPYRROLATE HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE IMIPRAMINE HYDROCHLORIDE, IMIPRAMINE HYDROCHLORIDE LORAZEPAM, LORAZEPAM EXELA PHARMA SCIENCE * EXELA PHARMA SCIENCES NICARDIPINE HYDROCHLORIDE, NICARDIPINE HYDROCHLORIDE EXELA PHARMA SCS LLC * EXELA PHARMA SCIENCES LLC CLONIDINE HYDROCHLORIDE, CLONIDINE HYDROCHLORIDE EXELIXIS * EXELIXIS INC COMETRIQ, CABOZANTINIB S-MALATE FOUGERA * E FOUGERA DIV ALTANA INC BETAMETHASONE DIPROPIONATE, BETAMETHASONE DIPROPIONATE FLUOCINONIDE, FLUOCINONIDE GENTAMICIN SULFATE, GENTAMICIN SULFATE HYDROCORTISONE, HYDROCORTISONE LIDOCAINE, LIDOCAINE NITROGLYCERIN, NITROGLYCERIN NYSTATIN AND TRIAMCINOLONE ACETONIDE, NYSTATIN LILLY * ELI LILLY AND CO ALIMTA, PEMETREXED DISODIUM CIALIS, TADALAFIL CYMBALTA, DULOXETINE HYDROCHLORIDE FORTEO, TERIPARATIDE RECOMBINANT HUMAN GEMZAR, GEMCITABINE HYDROCHLORIDE 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, INSULIN LISPRO RECOMBINANT PROZAC WEEKLY, FLUOXETINE HYDROCHLORIDE STRATTERA, ATOMOXETINE HYDROCHLORIDE SYMBYAX, FLUOXETINE HYDROCHLORIDE ZYPREXA ZYDIS, OLANZAPINE ZYPREXA, OLANZAPINE ** F ** FACTA FARMA * FACTA FARMACEUTICI SPA CEPHALEXIN, CEPHALEXIN FALCON PHARMS * FALCON PHARMACEUTICALS INC TIMOLOL MALEATE, TIMOLOL MALEATE * FALCON PHARMACEUTICALS LTD METIPRANOLOL, METIPRANOLOL HYDROCHLORIDE FAMY CARE LTD * FAMY CARE LTD DESOGESTREL AND ETHINYL ESTRADIOL, DESOGESTREL LEVONORGESTREL AND ETHINYL ESTRADIOL, ETHINYL ESTRADIOL B - 38 DECEMBER 2013 - APPROVED DRUG PRODUCT LIST APPENDIX B - PRODUCT NAME SORTED BY APPLICANT ** F ** * FAMY CARE LTD NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL, ETHINYL ESTRADIOL NORETHINDRONE AND ETHINYL ESTRADIOL, ETHINYL ESTRADIOL NORETHINDRONE, NORETHINDRONE 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 FERA PHARMS * FERA PHARMACEUTICALS LLC OFLOXACIN, OFLOXACIN TOBRAMYCIN, TOBRAMYCIN FERRING * FERRING PHARMACEUTICALS INC BRAVELLE, UROFOLLITROPIN CHORIONIC GONADOTROPIN, GONADOTROPIN, CHORIONIC DESMOPRESSIN ACETATE, DESMOPRESSIN ACETATE ENDOMETRIN, PROGESTERONE FIRMAGON, DEGARELIX ACETATE MENOPUR, MENOTROPINS (FSH MINIRIN, DESMOPRESSIN ACETATE REPRONEX, MENOTROPINS (FSH TEV-TROPIN, SOMATROPIN RECOMBINANT FERRING CONTROLLED * FERRING CONTROLLED THERAPEUTICS LTD CERVIDIL, DINOPROSTONE FERRING PHARMS AS * FERRING PHARMACEUTICALS AS LYSTEDA, TRANEXAMIC ACID PREPOPIK, CITRIC ACID FOREST LABS * FOREST LABORATORIES INC BYSTOLIC, NEBIVOLOL HYDROCHLORIDE CAMPRAL, ACAMPROSATE CALCIUM CELEXA, CITALOPRAM HYDROBROMIDE LEXAPRO, ESCITALOPRAM OXALATE NAMENDA XR, MEMANTINE HYDROCHLORIDE NAMENDA, MEMANTINE HYDROCHLORIDE THYROLAR-0.25, LIOTRIX (T4 THYROLAR-0.5, LIOTRIX (T4 THYROLAR-1, LIOTRIX (T4 THYROLAR-2, LIOTRIX (T4 THYROLAR-3, LIOTRIX (T4 FOREST LABS INC * FOREST LABORATORIES INC FETZIMA, LEVOMILNACIPRAN HYDROCHLORIDE LINZESS, LINACLOTIDE TUDORZA PRESSAIR, ACLIDINIUM BROMIDE VIIBRYD, VILAZODONE HYDROCHLORIDE FOREST RES INST INC * FOREST RESEARCH INSTITUTE INC DALIRESP, ROFLUMILAST FOUGERA PHARMS * FOUGERA PHARMACEUTICALS INC ACLOVATE, ALCLOMETASONE DIPROPIONATE ADAPALENE, ADAPALENE ALCLOMETASONE DIPROPIONATE, ALCLOMETASONE DIPROPIONATE AMCINONIDE, AMCINONIDE BETAMETHASONE DIPROPIONATE, BETAMETHASONE DIPROPIONATE B - 39 DECEMBER 2013 - APPROVED DRUG PRODUCT LIST APPENDIX B - PRODUCT NAME SORTED BY APPLICANT ** F ** * FOUGERA PHARMACEUTICALS INC C-SOLVE-2, ERYTHROMYCIN CALCIPOTRIENE, CALCIPOTRIENE CICLOPIROX, CICLOPIROX CLINDAMYCIN PHOSPHATE, CLINDAMYCIN PHOSPHATE CLOBETASOL PROPIONATE (EMOLLIENT), CLOBETASOL PROPIONATE CLOBETASOL PROPIONATE, CLOBETASOL PROPIONATE CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE, BETAMETHASONE DIPROPIONATE CLOTRIMAZOLE, CLOTRIMAZOLE CUTIVATE, FLUTICASONE PROPIONATE DESONIDE, DESONIDE DESOXIMETASONE, DESOXIMETASONE DIFLORASONE DIACETATE, DIFLORASONE DIACETATE ECONAZOLE NITRATE, ECONAZOLE NITRATE ERYTHROMYCIN, ERYTHROMYCIN FLUOCINONIDE EMULSIFIED BASE, FLUOCINONIDE FLUOCINONIDE, FLUOCINONIDE FLUTICASONE PROPIONATE, FLUTICASONE PROPIONATE HALOBETASOL PROPIONATE, HALOBETASOL PROPIONATE HYDROCORTISONE, HYDROCORTISONE IMIQUIMOD, IMIQUIMOD KETOCONAZOLE, KETOCONAZOLE LIDOCAINE AND PRILOCAINE, LIDOCAINE METRONIDAZOLE, METRONIDAZOLE MOMETASONE FUROATE, MOMETASONE FUROATE MUPIROCIN, MUPIROCIN NYSTATIN, NYSTATIN OXISTAT, OXICONAZOLE NITRATE PAMINE FORTE, METHSCOPOLAMINE BROMIDE PAMINE, METHSCOPOLAMINE BROMIDE PANDEL, HYDROCORTISONE PROBUTATE PREDNICARBATE, PREDNICARBATE SOLARAZE, DICLOFENAC SODIUM SULFACETAMIDE SODIUM, SULFACETAMIDE SODIUM TEMOVATE E, CLOBETASOL PROPIONATE TEMOVATE, CLOBETASOL PROPIONATE TERCONAZOLE, TERCONAZOLE TRIAMCINOLONE ACETONIDE, TRIAMCINOLONE ACETONIDE TYZINE, TETRAHYDROZOLINE HYDROCHLORIDE ZONALON, DOXEPIN HYDROCHLORIDE FRESENIUS * FRESENIUS KABI DEUTSCHLAND GMBH INTRALIPID 10%, SOYBEAN OIL INTRALIPID 20%, SOYBEAN OIL INTRALIPID 30%, SOYBEAN OIL FRESENIUS KABI * FRESENIUS KABI AUSTRIA GMBH LACTULOSE, LACTULOSE FRESENIUS KABI ONCOL * FRESENIUS KABI ONCOLOGY PLC ANASTROZOLE, ANASTROZOLE BICALUTAMIDE, BICALUTAMIDE CARBOPLATIN, CARBOPLATIN GEMCITABINE HYDROCHLORIDE, GEMCITABINE HYDROCHLORIDE LETROZOLE, LETROZOLE OXALIPLATIN, OXALIPLATIN TOPOTECAN HYDROCHLORIDE, TOPOTECAN HYDROCHLORIDE FRESENIUS KABI USA * FRESENIUS KABI USA LLC CLADRIBINE, CLADRIBINE DEXAMETHASONE SODIUM PHOSPHATE, DEXAMETHASONE SODIUM PHOSPHATE DIMENHYDRINATE, DIMENHYDRINATE FLUDARABINE PHOSPHATE, FLUDARABINE PHOSPHATE GENTAMICIN SULFATE, GENTAMICIN SULFATE LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER, LEVOFLOXACIN B - 40 DECEMBER 2013 - APPROVED DRUG PRODUCT LIST APPENDIX B - PRODUCT NAME SORTED BY APPLICANT ** F FRESENIUS MEDCL * FRESENIUS MEDICAL CARE NORTH AMERICA CALCITRIOL, CALCITRIOL PHOSLO GELCAPS, CALCIUM ACETATE PHOSLYRA, CALCIUM ACETATE SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, FSC * FSC LABORATORIES INC PRIMSOL, TRIMETHOPRIM HYDROCHLORIDE ** G ** SODIUM CHLORIDE ** G AND W LABS * G AND W LABORATORIES INC CICLOPIROX, CICLOPIROX FLUOCINOLONE ACETONIDE, FLUOCINOLONE ACETONIDE FLUTICASONE PROPIONATE, FLUTICASONE PROPIONATE HALOBETASOL PROPIONATE, HALOBETASOL PROPIONATE INDOMETHACIN, INDOMETHACIN METRONIDAZOLE, METRONIDAZOLE MICONAZOLE 7 COMBINATION PACK, MICONAZOLE NITRATE (OTC) MOMETASONE FUROATE, MOMETASONE FUROATE PROCHLORPERAZINE, PROCHLORPERAZINE PROMETHAZINE HYDROCHLORIDE, PROMETHAZINE HYDROCHLORIDE PROMETHEGAN, PROMETHAZINE HYDROCHLORIDE G AND W LABS INC * G AND W LABORATORIES INC CALCIPOTRIENE, CALCIPOTRIENE CICLOPIROX, CICLOPIROX FLUOCINONIDE, FLUOCINONIDE METRONIDAZOLE, METRONIDAZOLE MICONAZOLE NITRATE, MICONAZOLE NITRATE (OTC) GALDERMA LABS * GALDERMA LABORATORIES INC CLOBEX, CLOBETASOL PROPIONATE GALDERMA LABS LP * GALDERMA LABORATORIES L P CLOBEX, CLOBETASOL PROPIONATE * GALDERMA LABORATORIES LP CAPEX, FLUOCINOLONE ACETONIDE CLOBEX, CLOBETASOL PROPIONATE DESOWEN, DESONIDE DIFFERIN, ADAPALENE EPIDUO, ADAPALENE METROCREAM, METRONIDAZOLE METROGEL, METRONIDAZOLE METROLOTION, METRONIDAZOLE MIRVASO, BRIMONIDINE TARTRATE ORACEA, DOXYCYCLINE PERIOSTAT, DOXYCYCLINE HYCLATE PLIAGLIS, LIDOCAINE TRI-LUMA, FLUOCINOLONE ACETONIDE VECTICAL, CALCITRIOL GALEN (UK) * GALEN LTD DAUNOXOME, DAUNORUBICIN CITRATE GALEN SPECIALTY * GALEN SPECIALTY PHARMA US LLC SYNERA, LIDOCAINE GALENA BIOPHARMA * GALENA BIOPHARMA ABSTRAL, FENTANYL CITRATE GAMBRO RENAL PRODS * GAMBRO RENAL PRODUCTS PRISMASOL B22GK 2/0 IN PLASTIC CONTAINER, CALCIUM CHLORIDE B - 41 DECEMBER 2013 - APPROVED DRUG PRODUCT LIST APPENDIX B - PRODUCT NAME SORTED BY APPLICANT ** G ** * GAMBRO RENAL PRODUCTS 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 GASTROENTERO * GASTROENTERO LOGIC LLC OMEPRAZOLE AND CLARITHROMYCIN AND AMOXICILLIN, AMOXICILLIN GATE PHARMS * GATE PHARMACEUTICALS CLOPIDOGREL BISULFATE, CLOPIDOGREL BISULFATE GAVIS PHARMS * GAVIS PHARMACEUTICALS LLC ACETAMINOPHEN AND PENTAZOCINE HYDROCHLORIDE, ACETAMINOPHEN NALOXONE HYDROCHLORIDE AND PENTAZOCINE HYDROCHLORIDE, NALOXONE HYDROCHLORIDE NYSTATIN, NYSTATIN ORPHENADRINE CITRATE, ORPHENADRINE CITRATE QUINARETIC, HYDROCHLOROTHIAZIDE TRIMETHOBENZAMIDE HYDROCHLORIDE, TRIMETHOBENZAMIDE HYDROCHLORIDE GD SEARLE * GD SEARLE LLC CELEBREX, CELECOXIB GD SEARLE LLC * GD SEARLE LLC ARTHROTEC, DICLOFENAC SODIUM CALAN, VERAPAMIL HYDROCHLORIDE CYTOTEC, MISOPROSTOL FLAGYL ER, METRONIDAZOLE FLAGYL, METRONIDAZOLE INSPRA, EPLERENONE GE HEALTHCARE * GE HEALTHCARE ADREVIEW, IOBENGUANE SULFATE I-123 CERETEC, TECHNETIUM TC-99M EXAMETAZIME KIT INDICLOR, INDIUM IN-111 CHLORIDE INDIUM IN-111 OXYQUINOLINE, INDIUM IN-111 OXYQUINOLINE METASTRON, STRONTIUM CHLORIDE SR-89 MPI INDIUM DTPA IN 111, INDIUM IN-111 PENTETATE DISODIUM MYOVIEW 30ML, TECHNETIUM TC-99M TETROFOSMIN KIT MYOVIEW, TECHNETIUM TC-99M TETROFOSMIN KIT OMNISCAN, GADODIAMIDE THALLOUS CHLORIDE TL 201, THALLOUS CHLORIDE TL-201 VISIPAQUE 270, IODIXANOL VISIPAQUE 320, IODIXANOL VIZAMYL, FLUTEMETAMOL F-18 GE HLTHCARE INC * GE HEALTHCARE INC DATSCAN, IOFLUPANE I-123 GEDEON RICHTER USA * GEDEON RICHTER USA INC FINASTERIDE, FINASTERIDE GENENTECH * GENENTECH INC ERIVEDGE, VISMODEGIB NUTROPIN AQ PEN, SOMATROPIN RECOMBINANT NUTROPIN AQ, SOMATROPIN RECOMBINANT GENZYME * GENZYME CORP CLOLAR, CLOFARABINE B - 42 DECEMBER 2013 - APPROVED DRUG PRODUCT LIST APPENDIX B - PRODUCT NAME SORTED BY APPLICANT ** G ** * GENZYME CORP MOZOBIL, PLERIXAFOR RENAGEL, SEVELAMER HYDROCHLORIDE RENVELA, SEVELAMER CARBONATE GENZYME CORP * GENZYME CORP HECTOROL, DOXERCALCIFEROL KYNAMRO, MIPOMERSEN SODIUM GILEAD * GILEAD SCIENCES INC ATRIPLA, EFAVIRENZ CAYSTON, AZTREONAM EMTRIVA, EMTRICITABINE HEPSERA, ADEFOVIR DIPIVOXIL LETAIRIS, AMBRISENTAN RANEXA, RANOLAZINE TRUVADA, EMTRICITABINE GILEAD SCIENCES INC * GILEAD SCIENCES INC COMPLERA, EMTRICITABINE SOLVADI, SOFOSBUVIR STRIBILD, COBICISTAT VIREAD, TENOFOVIR DISOPROXIL FUMARATE VISTIDE, CIDOFOVIR GLAND PHARMA LTD * GLAND PHARMA LTD ADENOSINE, ADENOSINE AMIODARONE HYDROCHLORIDE, AMIODARONE HYDROCHLORIDE AZITHROMYCIN, AZITHROMYCIN HALOPERIDOL, HALOPERIDOL LACTATE LABETALOL HYDROCHLORIDE, LABETALOL HYDROCHLORIDE MIDAZOLAM HYDROCHLORIDE, MIDAZOLAM HYDROCHLORIDE MILRINONE LACTATE, MILRINONE LACTATE ONDANSETRON HYDROCHLORIDE, ONDANSETRON HYDROCHLORIDE ZOLEDRONIC ACID, ZOLEDRONIC ACID GLATT AIR * GLATT AIR TECHNIQUES INC PROPRANOLOL HYDROCHLORIDE, PROPRANOLOL HYDROCHLORIDE GLAXO GRP LTD * GLAXO GROUP LTD DBA GLAXOSMITHKLINE ALTABAX, RETAPAMULIN FLOVENT HFA, FLUTICASONE PROPIONATE SEREVENT, SALMETEROL XINAFOATE * GLAXO GROUP LTD ENGLAND DBA GLAXOSMITHKLINE ADVAIR DISKUS 100/50, FLUTICASONE PROPIONATE ADVAIR DISKUS 250/50, FLUTICASONE PROPIONATE ADVAIR DISKUS 500/50, FLUTICASONE PROPIONATE ADVAIR HFA, FLUTICASONE PROPIONATE ANORO ELLIPTA, UMECLIDINIUM BROMIDE BREO ELLIPTA, FLUTICASONE FUROATE FLOVENT DISKUS 100, FLUTICASONE PROPIONATE FLOVENT DISKUS 250, FLUTICASONE PROPIONATE FLOVENT DISKUS 50, FLUTICASONE PROPIONATE VENTOLIN HFA, ALBUTEROL SULFATE ZANTAC 150, RANITIDINE HYDROCHLORIDE ZANTAC 300, RANITIDINE HYDROCHLORIDE ZANTAC, RANITIDINE HYDROCHLORIDE GLAXO WELLCOME * GLAXOSMITHKLINE HYCAMTIN, TOPOTECAN HYDROCHLORIDE GLAXOSMITHKLINE * GLAXOSMITHKLINE ALKERAN, MELPHALAN HYDROCHLORIDE ARIXTRA, FONDAPARINUX SODIUM AVODART, DUTASTERIDE B - 43 DECEMBER 2013 - APPROVED DRUG PRODUCT LIST APPENDIX B - PRODUCT NAME SORTED BY APPLICANT ** G ** * GLAXOSMITHKLINE BACTROBAN, MUPIROCIN BACTROBAN, MUPIROCIN CALCIUM BECONASE AQ, BECLOMETHASONE DIPROPIONATE MONOHYDRATE CEFTIN, CEFUROXIME AXETIL EPIVIR-HBV, LAMIVUDINE FLONASE, FLUTICASONE PROPIONATE HYCAMTIN, TOPOTECAN HYDROCHLORIDE IMITREX STATDOSE, SUMATRIPTAN SUCCINATE IMITREX, SUMATRIPTAN SUCCINATE JALYN, DUTASTERIDE MALARONE PEDIATRIC, ATOVAQUONE MALARONE, ATOVAQUONE NICORETTE (MINT), NICOTINE POLACRILEX (OTC) NICORETTE, NICOTINE POLACRILEX (OTC) PAXIL CR, PAROXETINE HYDROCHLORIDE PAXIL, PAROXETINE HYDROCHLORIDE POTIGA, EZOGABINE PROMACTA, ELTROMBOPAG OLAMINE RELENZA, ZANAMIVIR TAFINLAR, DABRAFENIB MESYLATE VALTREX, VALACYCLOVIR HYDROCHLORIDE VERAMYST, FLUTICASONE FUROATE VOTRIENT, PAZOPANIB HYDROCHLORIDE WELLBUTRIN SR, BUPROPION HYDROCHLORIDE ZOFRAN ODT, ONDANSETRON ZOFRAN PRESERVATIVE FREE, ONDANSETRON HYDROCHLORIDE ZOFRAN, ONDANSETRON HYDROCHLORIDE ZYBAN, BUPROPION HYDROCHLORIDE GLAXOSMITHKLINE CONS * GLAXOSMITHKLINE CONSUMER HEALTHCARE ALLI, ORLISTAT (OTC) COMMIT, NICOTINE POLACRILEX (OTC) NICORETTE, NICOTINE POLACRILEX (OTC) GLAXOSMITHKLINE LLC * GLAXOSMITHKLINE LLC AMERGE, NARATRIPTAN HYDROCHLORIDE DYAZIDE, HYDROCHLOROTHIAZIDE FLOLAN, EPOPROSTENOL SODIUM INNOPRAN XL, PROPRANOLOL HYDROCHLORIDE LAMICTAL CD, LAMOTRIGINE LAMICTAL ODT, LAMOTRIGINE LAMICTAL XR, LAMOTRIGINE LAMICTAL, LAMOTRIGINE MEKINIST, TRAMETINIB DIMETHYL SULFOXIDE MEPRON, ATOVAQUONE REQUIP XL, ROPINIROLE HYDROCHLORIDE REQUIP, ROPINIROLE HYDROCHLORIDE RYTHMOL SR, PROPAFENONE HYDROCHLORIDE RYTHMOL, PROPAFENONE HYDROCHLORIDE GLENMARK GENERICS * GLENMARK GENERICS INC USA ADAPALENE, ADAPALENE BETAMETHASONE DIPROPIONATE, BETAMETHASONE DIPROPIONATE CALCIPOTRIENE, CALCIPOTRIENE IMIQUIMOD, IMIQUIMOD MOMETASONE FUROATE, MOMETASONE FUROATE MUPIROCIN, MUPIROCIN CALCIUM NIZATIDINE, NIZATIDINE RANITIDINE HYDROCHLORIDE, RANITIDINE HYDROCHLORIDE * GLENMARK GENERICS LIMITED BRIELLYN, ETHINYL ESTRADIOL FLUTICASONE PROPIONATE, FLUTICASONE PROPIONATE LEVOCETIRIZINE DIHYDROCHLORIDE, LEVOCETIRIZINE DIHYDROCHLORIDE * GLENMARK GENERICS LTD B - 44 DECEMBER 2013 - APPROVED DRUG PRODUCT LIST APPENDIX B - PRODUCT NAME SORTED BY APPLICANT ** G ** * GLENMARK GENERICS LTD ACAMPROSATE CALCIUM, ACAMPROSATE CALCIUM ALCLOMETASONE DIPROPIONATE, ALCLOMETASONE DIPROPIONATE ALYACEN 1/35, ETHINYL ESTRADIOL ALYACEN 7/7/7, ETHINYL ESTRADIOL ATOVAQUONE AND PROGUANIL HYDROCHLORIDE, ATOVAQUONE CICLOPIROX, CICLOPIROX CITALOPRAM HYDROBROMIDE, CITALOPRAM HYDROBROMIDE DESOXIMETASONE, DESOXIMETASONE FELODIPINE, FELODIPINE HEATHER, NORETHINDRONE HYDROCORTISONE BUTYRATE, HYDROCORTISONE BUTYRATE LAMOTRIGINE, LAMOTRIGINE LEVOFLOXACIN, LEVOFLOXACIN LITHIUM CARBONATE, LITHIUM CARBONATE MARLISSA, ETHINYL ESTRADIOL METFORMIN HYDROCHLORIDE, METFORMIN HYDROCHLORIDE MOEXIPRIL HYDROCHLORIDE, MOEXIPRIL HYDROCHLORIDE MOMETASONE FUROATE, MOMETASONE FUROATE MONTELUKAST SODIUM, MONTELUKAST SODIUM NORETHIDRONE, NORETHINDRONE NORGESTIMATE AND ETHINYL ESTRADIOL, ETHINYL ESTRADIOL RILUZOLE, RILUZOLE RIZATRIPTAN BENZOATE, RIZATRIPTAN BENZOATE ROPINIROLE HYDROCHLORIDE, ROPINIROLE HYDROCHLORIDE SULFAMETHOXAZOLE AND TRIMETHOPRIM, SULFAMETHOXAZOLE THEOPHYLLINE, THEOPHYLLINE TOPIRAMATE, TOPIRAMATE TRANDOLAPRIL AND VERAPAMIL HYDROCHLORIDE, TRANDOLAPRIL TROSPIUM CHLORIDE, TROSPIUM CHLORIDE URSODIOL, URSODIOL VERAPAMIL HYDROCHLORIDE, VERAPAMIL HYDROCHLORIDE VIORELE, DESOGESTREL ZOLMITRIPTAN, ZOLMITRIPTAN * GLENMARK GENERICS LTD INDIA INDOMETHACIN, INDOMETHACIN LITHIUM CARBONATE, LITHIUM CARBONATE NORETHINDRONE ACETATE, NORETHINDRONE ACETATE PRAMIPEXOLE DIHYDROCHLORIDE, PRAMIPEXOLE DIHYDROCHLORIDE GLENMARK PHARMS * GLENMARK PHARMACEUTICALS INC USA CICLOPIROX, CICLOPIROX CLOTRIMAZOLE, CLOTRIMAZOLE MUPIROCIN, MUPIROCIN * GLENMARK PHARMACEUTICALS LTD MOEXIPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE GLENMARK PHARMS LTD * GLENMARK PHARMACEUTICALS LTD HYDRALAZINE HYDROCHLORIDE, HYDRALAZINE HYDROCHLORIDE GRANULES INDIA * GRANULES INDIA LTD IBUPROFEN, IBUPROFEN (OTC) METFORMIN HYDROCHLORIDE, METFORMIN HYDROCHLORIDE NAPROXEN SODIUM, NAPROXEN SODIUM (OTC) GUERBET * GUERBET LLC DOTAREM, GADOTERATE MEGLUMINE HEXABRIX, IOXAGLATE MEGLUMINE OXILAN-300, IOXILAN OXILAN-350, IOXILAN HANFORD GC * GC HANFORD MANUFACTURING CO AMPICILLIN AND SULBACTAM, AMPICILLIN SODIUM AMPICILLIN SODIUM, AMPICILLIN SODIUM PENICILLIN G POTASSIUM, PENICILLIN G POTASSIUM B - 45 DECEMBER 2013 - APPROVED DRUG PRODUCT LIST APPENDIX B - PRODUCT NAME SORTED BY APPLICANT ** H ** HAEMONETICS * HAEMONETICS CORP SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, SODIUM CHLORIDE HALOCARBON PRODS * HALOCARBON PRODUCTS CORP SEVOFLURANE, SEVOFLURANE HALOZYME THERAP * HALOZYME THERAPEUTICS INC HYLENEX RECOMBINANT, HYALURONIDASE RECOMBINANT HUMAN HAMELN RDS GMBH * HAMELN RDS GMBH GEMCITABINE HYDROCHLORIDE, GEMCITABINE HYDROCHLORIDE HANMI PHARM CO LTD * HANMI PHARMACEUTICAL CO LTD ESOMEPRAZOLE STRONTIUM, ESOMEPRAZOLE STRONTIUM HARRIS PHARM * HARRIS PHARMACEUTICAL INC TERBINAFINE HYDROCHLORIDE, TERBINAFINE HYDROCHLORIDE HAUPT PHARMA * HAUPT PHARMA INC NORETHINDRONE, NORETHINDRONE HELSINN HLTHCARE * HELSINN HEALTHCARE SA ALOXI, PALONOSETRON HYDROCHLORIDE HERCON PHARM * HERCON PHARMACEUTICAL LLC NITROGLYCERIN, NITROGLYCERIN HERITAGE PHARMS INC * HERITAGE PHARMACEUTICALS INC ACETAZOLAMIDE, ACETAZOLAMIDE ACHROMYCIN V, TETRACYCLINE HYDROCHLORIDE CARISOPRODOL AND ASPIRIN, ASPIRIN DOXYCYCLINE HYCLATE, DOXYCYCLINE HYCLATE DOXYCYCLINE, DOXYCYCLINE FELODIPINE, FELODIPINE FLUOXETINE HYDROCHLORIDE, FLUOXETINE HYDROCHLORIDE GLIPIZIDE AND METFORMIN HYDROCHLORIDE, GLIPIZIDE GLYBURIDE AND METFORMIN HYDROCHLORIDE, GLYBURIDE GLYBURIDE, GLYBURIDE HYDRALAZINE HYDROCHLORIDE, HYDRALAZINE HYDROCHLORIDE HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE HYDROXYZINE HYDROCHLORIDE, HYDROXYZINE HYDROCHLORIDE INDOMETHACIN, INDOMETHACIN LEFLUNOMIDE, LEFLUNOMIDE NARATRIPTAN, NARATRIPTAN HYDROCHLORIDE NYSTATIN, NYSTATIN PAROMOMYCIN SULFATE, PAROMOMYCIN SULFATE SULINDAC, SULINDAC VENLAFAXINE HYDROCHLORIDE, VENLAFAXINE HYDROCHLORIDE VERAPAMIL HYDROCHLORIDE, VERAPAMIL HYDROCHLORIDE HETERO LABS LTD III * HETERO LABS LTD UNIT III ABACAVIR SULFATE, ABACAVIR SULFATE ESCITALOPRAM OXALATE, ESCITALOPRAM OXALATE FINASTERIDE, FINASTERIDE HYDRALAZINE HYDROCHLORIDE, HYDRALAZINE HYDROCHLORIDE HYDROXYZINE HYDROCHLORIDE, HYDROXYZINE HYDROCHLORIDE INDOMETHACIN, INDOMETHACIN LEVETIRACETAM, LEVETIRACETAM LEVOCETIRIZINE DIHYDROCHLORIDE, LEVOCETIRIZINE DIHYDROCHLORIDE LITHIUM CARBONATE, LITHIUM CARBONATE METHOCARBAMOL, METHOCARBAMOL NEVIRAPINE, NEVIRAPINE STAVUDINE, STAVUDINE B - 46 DECEMBER 2013 - APPROVED DRUG PRODUCT LIST APPENDIX B - PRODUCT NAME SORTED BY APPLICANT ** H ** * HETERO LABS LTD UNIT III TORSEMIDE, TORSEMIDE ZIDOVUDINE, ZIDOVUDINE HETERO LABS LTD V * HETERO LABS LTD UNIT V ACYCLOVIR, ACYCLOVIR IRBESARTAN, IRBESARTAN LAMIVUDINE, LAMIVUDINE HEYL CHEMISCH * HEYL CHEMISCH PHARMAZEUTISHE FABRIK RADIOGARDASE (PRUSSIAN BLUE), FERRIC HEXACYANOFERRATE(II) HI TECH PHARMA * HI TECH PHARMACAL CO INC ACYCLOVIR, ACYCLOVIR AMANTADINE HYDROCHLORIDE, AMANTADINE HYDROCHLORIDE CALCIPOTRIENE, CALCIPOTRIENE CICLOPIROX, CICLOPIROX CIMETIDINE HYDROCHLORIDE, CIMETIDINE HYDROCHLORIDE DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE, DORZOLAMIDE HYDROCHLORIDE DORZOLAMIDE HYDROCHLORIDE, DORZOLAMIDE HYDROCHLORIDE EMBELINE, CLOBETASOL PROPIONATE ERYTHRO-STATIN, ERYTHROMYCIN FLUTICASONE PROPIONATE, FLUTICASONE PROPIONATE GABAPENTIN, GABAPENTIN HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE, HOMATROPINE METHYLBROMIDE HYDROXYZINE HYDROCHLORIDE, HYDROXYZINE HYDROCHLORIDE LEVOCARNITINE, LEVOCARNITINE LEVOFLOXACIN, LEVOFLOXACIN LIDOCAINE AND PRILOCAINE, LIDOCAINE LIDOCAINE HYDROCHLORIDE, LIDOCAINE HYDROCHLORIDE MIDAZOLAM HYDROCHLORIDE, MIDAZOLAM HYDROCHLORIDE MINOXIDIL (FOR WOMEN), MINOXIDIL (OTC) NYSTATIN, NYSTATIN OFLOXACIN, OFLOXACIN PREDNISOLONE SODIUM PHOSPHATE, PREDNISOLONE SODIUM PHOSPHATE PROMETHAZINE HYDROCHLORIDE, PROMETHAZINE HYDROCHLORIDE RANITIDINE HYDROCHLORIDE, RANITIDINE HYDROCHLORIDE SULFAMETHOXAZOLE AND TRIMETHOPRIM, SULFAMETHOXAZOLE TIMOLOL MALEATE, TIMOLOL MALEATE VOSOL HC, ACETIC ACID, GLACIAL VOSOL, ACETIC ACID, GLACIAL HI TECH PHARMA CO * HI TECH PHARMACAL CO INC FLUNISOLIDE, FLUNISOLIDE PREDNISOLONE, PREDNISOLONE TUSSICAPS, CHLORPHENIRAMINE POLISTIREX HI-TECH PHARMA CO * HI-TECH PHARMACAL CO INC LORAZEPAM, LORAZEPAM HI-TECH PHARMACAL * HI-TECH PHARMACAL CO INC LEVETIRACETAM, LEVETIRACETAM 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 B - 47 DECEMBER 2013 - APPROVED DRUG PRODUCT LIST APPENDIX B - PRODUCT NAME SORTED BY APPLICANT ** H ** * HIKMA PHARMACEUTICALS ZOLPIDEM TARTRATE, ZOLPIDEM TARTRATE HIKMA (MAPLE) * HIKMA (MAPLE) LTD SODIUM CHLORIDE 0.9%, SODIUM CHLORIDE 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 CIPROFLOXACIN, CIPROFLOXACIN CLONIDINE HYDROCHLORIDE, CLONIDINE HYDROCHLORIDE ENALAPRILAT, ENALAPRILAT FLUCONAZOLE IN DEXTROSE 5% IN PLASTIC CONTAINER, FLUCONAZOLE FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, FLUCONAZOLE FLUMAZENIL, FLUMAZENIL FOSPHENYTOIN SODIUM, FOSPHENYTOIN SODIUM GLYCOPYRROLATE, GLYCOPYRROLATE GRANISTERON HYDROCHLORIDE, GRANISETRON HYDROCHLORIDE IRINOTECAN HYDROCHLORIDE, IRINOTECAN HYDROCHLORIDE LEVETIRACETAM, LEVETIRACETAM LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER, LEVOFLOXACIN METOPROLOL TARTRATE, METOPROLOL TARTRATE MILRINONE LACTATE IN PLASTIC CONTAINER, MILRINONE LACTATE MILRINONE LACTATE, MILRINONE LACTATE ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE, ONDANSETRON HYDROCHLORIDE ONDANSETRON HYDROCHLORIDE, ONDANSETRON HYDROCHLORIDE PROGESTERONE, PROGESTERONE PROPRANOLOL HYDROCHLORIDE, PROPRANOLOL HYDROCHLORIDE TERBUTALINE SULFATE, TERBUTALINE SULFATE TESTOSTERONE CYPIONATE, TESTOSTERONE CYPIONATE 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 PORTUGAL SA DILTIAZEM HYDROCHLORIDE, DILTIAZEM HYDROCHLORIDE OXYTOCIN, OXYTOCIN SUMATRIPTAN SUCCINATE, SUMATRIPTAN SUCCINATE TESTOSTERONE ENANTHATE, TESTOSTERONE ENANTHATE * HIKMA FARMACEUTICA SA BUTORPHANOL TARTRATE, BUTORPHANOL TARTRATE ZOLEDRONIC ACID, ZOLEDRONIC ACID HIKMA MAPLE * HIKMA MAPLE LTD ACYCLOVIR IN SODIUM CHLORIDE 0.9% PRESERVATIVE FREE, ACYCLOVIR SODIUM ACYCLOVIR SODIUM, ACYCLOVIR SODIUM ADENOSINE, ADENOSINE AMPICILLIN AND SULBACTAM, AMPICILLIN SODIUM BUMETANIDE, BUMETANIDE CEFOXITIN, CEFOXITIN SODIUM CHLORPROMAZINE HYDROCHLORIDE, CHLORPROMAZINE HYDROCHLORIDE CLINDAMYCIN PHOSPHATE, CLINDAMYCIN PHOSPHATE 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 B - 48 DECEMBER 2013 - APPROVED DRUG PRODUCT LIST APPENDIX B - PRODUCT NAME SORTED BY APPLICANT ** H ** * HIKMA MAPLE LTD 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 MEPERIDINE HYDROCHLORIDE PRESERVATIVE FREE, MEPERIDINE HYDROCHLORIDE MEPERIDINE HYDROCHLORIDE, MEPERIDINE HYDROCHLORIDE MIDAZOLAM HYDROCHLORIDE, MIDAZOLAM HYDROCHLORIDE MILRINONE LACTATE, MILRINONE LACTATE MITOMYCIN, MITOMYCIN ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE, ONDANSETRON HYDROCHLORIDE ONDANSETRON HYDROCHLORIDE, ONDANSETRON HYDROCHLORIDE PHENYTOIN SODIUM, PHENYTOIN SODIUM PROCHLORPERAZINE EDISYLATE, PROCHLORPERAZINE EDISYLATE PROMETHAZINE HYDROCHLORIDE, PROMETHAZINE HYDROCHLORIDE ROBAXIN, METHOCARBAMOL ROBINUL, GLYCOPYRROLATE SODIUM CHLORIDE 0.9% , SODIUM CHLORIDE SUFENTANIL CITRATE, SUFENTANIL CITRATE TOBRAMYCIN SULFATE, TOBRAMYCIN SULFATE VINORELBINE TARTRATE, VINORELBINE TARTRATE HIKMA PHARM CO LTD * HIKMA PHARM CO LTD ARGATROBAN, ARGATROBAN HIKMA PHARMS * HIKMA PHARMACEUTICALS AMLODIPINE BESYLATE, AMLODIPINE BESYLATE AMOXICILLIN AND CLAVULANATE POTASSIUM, AMOXICILLIN AMOXICILLIN, AMOXICILLIN CEFADROXIL, CEFADROXIL/CEFADROXIL HEMIHYDRATE CEPHALEXIN, CEPHALEXIN DIGOXIN, DIGOXIN DONEPEZIL HYDROCHLORIDE, DONEPEZIL HYDROCHLORIDE ESCITALOPRAM OXALATE, ESCITALOPRAM OXALATE GABAPENTIN, GABAPENTIN GEMFIBROZIL, GEMFIBROZIL GLIMEPIRIDE, GLIMEPIRIDE ISOSORBIDE MONONITRATE, ISOSORBIDE MONONITRATE LAMOTRIGINE, LAMOTRIGINE LISINOPRIL, LISINOPRIL METHOCARBAMOL, METHOCARBAMOL MODAFINIL, MODAFINIL PENICILLIN V POTASSIUM, PENICILLIN V POTASSIUM SERTRALINE HYDROCHLORIDE, SERTRALINE HYDROCHLORIDE SUMATRIPTAN SUCCINATE, SUMATRIPTAN SUCCINATE TOPIRAMATE , TOPIRAMATE * HIKMA PHARMACEUTICALS LLC DOXYCYCLINE HYCLATE, DOXYCYCLINE HYCLATE PREDNISONE, PREDNISONE SODIUM FERRIC GLUCONATE COMPLEX IN SUCROSE, SODIUM FERRIC GLUCONATE COMPLEX HIKMA PHARMS LLC * HIKMA PHARMACEUTICALS LLC DOXERCALCIFEROL, DOXERCALCIFEROL LISINOPRIL AND HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE HILL DERMAC * HILL DERMACEUTICALS INC DERMA-SMOOTHE/FS, FLUOCINOLONE ACETONIDE DERMOTIC, FLUOCINOLONE ACETONIDE HISAMITSU PHARM CO * HISAMITSU PHARMACEUTICAL CO INC SALONPAS, MENTHOL (OTC) B - 49 DECEMBER 2013 - APPROVED DRUG PRODUCT LIST APPENDIX B - PRODUCT NAME SORTED BY APPLICANT ** H ** HISUN PHARM HANGZHOU * HISUN PHARMACEUTICAL (HANGZHOU) CO LTD EPIRUBICIN HYDROCHLORIDE, EPIRUBICIN HYDROCHLORIDE IRINOTECAN HYDROCHLORIDE, IRINOTECAN HYDROCHLORIDE HITECH PHARMA * HITECH PHARMACAL CORP CIPROFLOXACIN HYDROCHLORIDE, CIPROFLOXACIN HYDROCHLORIDE HOFFMAN LA ROCHE * HOFFMAN LA ROCHE INC INVIRASE, SAQUINAVIR MESYLATE HOFFMANN LA ROCHE * HOFFMANN LA ROCHE INC ANAPROX DS, NAPROXEN SODIUM ANAPROX, NAPROXEN SODIUM BONIVA, IBANDRONATE SODIUM VALCYTE, VALGANCICLOVIR HYDROCHLORIDE XELODA, CAPECITABINE XENICAL, ORLISTAT ZELBORAF, VEMURAFENIB HOPE PHARMS * HOPE PHARMACEUTICALS NITHIODOTE, SODIUM NITRITE SODIUM NITRITE, SODIUM NITRITE SODIUM THIOSULFATE, SODIUM THIOSULFATE HORIZON PHARMA * HORIZON PHARMA INC DUEXIS, FAMOTIDINE RAYOS, PREDNISONE VIMOVO, ESOMEPRAZOLE MAGNESIUM HOSPIRA * HOSPIRA INC A-HYDROCORT, HYDROCORTISONE SODIUM SUCCINATE A-METHAPRED, METHYLPREDNISOLONE SODIUM SUCCINATE ACETIC ACID 0.25% IN PLASTIC CONTAINER, ACETIC ACID, GLACIAL ACETYLCYSTEINE, ACETYLCYSTEINE ALFENTANIL, ALFENTANIL HYDROCHLORIDE AMIDATE, ETOMIDATE 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 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 ARTICAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE, ARTICAINE HYDROCHLORIDE B - 50 DECEMBER 2013 - APPROVED DRUG PRODUCT LIST APPENDIX B - B - 51 PRODUCT NAME SORTED BY APPLICANT ** H ** * HOSPIRA INC 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 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 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 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 DILTIAZEM HYDROCHLORIDE, DILTIAZEM HYDROCHLORIDE DIPHENHYDRAMINE HYDROCHLORIDE, DIPHENHYDRAMINE HYDROCHLORIDE 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 ENALAPRILAT, ENALAPRILAT EPIRUBICIN HYDROCHLORIDE, EPIRUBICIN HYDROCHLORIDE ERYTHROCIN, ERYTHROMYCIN LACTOBIONATE 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 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 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 DECEMBER 2013 - APPROVED DRUG PRODUCT LIST APPENDIX B - PRODUCT NAME SORTED BY APPLICANT ** H ** * HOSPIRA INC HEPARIN SODIUM 12,500 UNITS IN SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER, HEPARIN HEPARIN SODIUM 2,000 UNITS IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, HEPARIN 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 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 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 LEVOPHED, NOREPINEPHRINE BITARTRATE LIDOCAINE HYDROCHLORIDE 0.4% IN DEXTROSE 5% IN PLASTIC CONTAINER, LIDOCAINE LIDOCAINE HYDROCHLORIDE 0.8% IN DEXTROSE 5% IN PLASTIC CONTAINER, LIDOCAINE 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 LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE, LIDOCAINE HYDROCHLORIDE 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 MORPHINE SULFATE, MORPHINE SULFATE NALBUPHINE HYDROCHLORIDE, NALBUPHINE HYDROCHLORIDE NALOXONE HYDROCHLORIDE, NALOXONE HYDROCHLORIDE NITROGLYCERIN IN DEXTROSE 5%, NITROGLYCERIN B - 52 DECEMBER 2013 - APPROVED DRUG PRODUCT LIST APPENDIX B - B - 53 PRODUCT NAME SORTED BY APPLICANT ** H ** * HOSPIRA INC 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 ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE, ONDANSETRON HYDROCHLORIDE ONDANSETRON HYDROCHLORIDE, ONDANSETRON HYDROCHLORIDE PACLITAXEL, PACLITAXEL PAMIDRONATE DISODIUM, PAMIDRONATE DISODIUM PANCURONIUM BROMIDE, PANCURONIUM BROMIDE PHENYTOIN SODIUM, PHENYTOIN SODIUM PHYSIOSOL 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 POTASSIUM CHLORIDE 10MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.225% IN PLASTIC POTASSIUM CHLORIDE 10MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.3% IN PLASTIC CONTAINER, POTASSIUM CHLORIDE 10MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER, POTASSIUM CHLORIDE 10MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, POTASSIUM CHLORIDE 10MEQ IN PLASTIC CONTAINER, POTASSIUM CHLORIDE POTASSIUM CHLORIDE 15MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.225% IN PLASTIC POTASSIUM CHLORIDE 15MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.3% IN PLASTIC CONTAINER, POTASSIUM CHLORIDE 15MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER, POTASSIUM CHLORIDE 15MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, POTASSIUM CHLORIDE 20MEQ IN DEXTROSE 5% AND LACTATED RINGER'S IN PLASTIC CONTAINER, POTASSIUM CHLORIDE 20MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.225% IN PLASTIC POTASSIUM CHLORIDE 20MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.3% IN PLASTIC CONTAINER, POTASSIUM CHLORIDE 20MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER, POTASSIUM CHLORIDE 20MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, POTASSIUM CHLORIDE 20MEQ IN DEXTROSE 5% IN PLASTIC CONTAINER, DEXTROSE POTASSIUM CHLORIDE 20MEQ IN DEXTROSE 5% IN SODIUM CHLORIDE 0.3% IN PLASTIC CONTAINER, POTASSIUM CHLORIDE 20MEQ IN PLASTIC CONTAINER, POTASSIUM CHLORIDE POTASSIUM CHLORIDE 20MEQ IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, POTASSIUM POTASSIUM CHLORIDE 30MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.225% IN PLASTIC POTASSIUM CHLORIDE 30MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.3% IN PLASTIC CONTAINER, POTASSIUM CHLORIDE 30MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER, POTASSIUM CHLORIDE 30MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, 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, POTASSIUM CHLORIDE 40MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.225% IN PLASTIC POTASSIUM CHLORIDE 40MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.3% IN PLASTIC CONTAINER, POTASSIUM CHLORIDE 40MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER, POTASSIUM CHLORIDE 40MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, 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 POTASSIUM CHLORIDE 5MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.225% IN PLASTIC CONTAINER, POTASSIUM CHLORIDE 5MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.3% IN PLASTIC CONTAINER, POTASSIUM CHLORIDE 5MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER, POTASSIUM CHLORIDE 5MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, 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 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 DECEMBER 2013 - APPROVED DRUG PRODUCT LIST APPENDIX B - B - 54 PRODUCT NAME SORTED BY APPLICANT ** H ** * HOSPIRA INC 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 TOBRAMYCIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, TOBRAMYCIN SULFATE TOBRAMYCIN SULFATE, TOBRAMYCIN SULFATE TPN ELECTROLYTES IN PLASTIC CONTAINER, CALCIUM CHLORIDE VANCOMYCIN HYDROCHLORIDE, VANCOMYCIN HYDROCHLORIDE VECURONIUM BROMIDE, VECURONIUM BROMIDE VERAPAMIL HYDROCHLORIDE, VERAPAMIL HYDROCHLORIDE VITAMIN K1, PHYTONADIONE ZINC CHLORIDE IN PLASTIC CONTAINER, ZINC CHLORIDE * HOSPIRA WORLDWIDE, INC DOBUTAMINE HYDROCHLORIDE, DOBUTAMINE HYDROCHLORIDE FLUDARABINE PHOSPHATE, FLUDARABINE PHOSPHATE GEMCITABINE HYDROCHLORIDE, GEMCITABINE HYDROCHLORIDE MITOXANTRONE HYDROCHLORIDE, MITOXANTRONE HYDROCHLORIDE NITROPRESS, SODIUM NITROPRUSSIDE TOBRAMYCIN SULFATE, TOBRAMYCIN SULFATE VINCRISTINE SULFATE PFS, VINCRISTINE SULFATE HOSPIRA INC * HOSPIRA INC A-METHAPRED, METHYLPREDNISOLONE SODIUM SUCCINATE AMIODARONE HYDROCHLORIDE, AMIODARONE HYDROCHLORIDE AMPICILLIN AND SULBACTAM, AMPICILLIN SODIUM ATRACURIUM BESYLATE PRESERVATIVE FREE, ATRACURIUM BESYLATE ATRACURIUM BESYLATE, ATRACURIUM BESYLATE CEFAZOLIN SODIUM, CEFAZOLIN SODIUM CEFEPIME HYDROCHLORIDE, CEFEPIME HYDROCHLORIDE CEFOTAXIME SODIUM, CEFOTAXIME SODIUM CEFOXITIN, CEFOXITIN SODIUM CEFTRIAXONE, CEFTRIAXONE SODIUM CEFUROXIME SODIUM, CEFUROXIME SODIUM DOCETAXEL, DOCETAXEL GEMCITABINE HYDROCHLORIDE, GEMCITABINE HYDROCHLORIDE HEPARIN SODIUM, HEPARIN SODIUM HYDROMORPHONE HYDROCHLORIDE, HYDROMORPHONE HYDROCHLORIDE IMIPENEM AND CILASTATIN, CILASTATIN SODIUM LEVETIRACETAM, LEVETIRACETAM MAXIPIME, CEFEPIME HYDROCHLORIDE MEPIVACAINE HYDROCHLORIDE, MEPIVACAINE HYDROCHLORIDE MEROPENEM, MEROPENEM MORPHINE SULFATE, MORPHINE SULFATE NIPENT, PENTOSTATIN OXALIPLATIN, OXALIPLATIN PIPERACILLIN AND TAZOBACTAM, PIPERACILLIN SODIUM THEOPHYLLINE IN DEXTROSE 5% IN PLASTIC CONTAINER, THEOPHYLLINE TOPOTECAN HYDROCHLORIDE, TOPOTECAN HYDROCHLORIDE VANCOMYCIN HYDROCHLORIDE, VANCOMYCIN HYDROCHLORIDE ZOLEDRONIC ACID, ZOLEDRONIC ACID HOSPIRA WORLDWIDE * HOSPIRA WORLDWIDE PTY OXALIPLATIN, OXALIPLATIN HOUSTON CYCLOTRON * HOUSTON CYCLOTRON PARTNERS LP AMMONIA N 13, AMMONIA N-13 FLUDEOXYGLUCOSE F18, FLUDEOXYGLUCOSE F-18 SODIUM FLUORIDE F-18, SODIUM FLUORIDE F-18 HQ SPCLT PHARMA * HQ SPECIALTY PHARMA CORP DECEMBER 2013 - APPROVED DRUG PRODUCT LIST APPENDIX B - PRODUCT NAME SORTED BY APPLICANT ** H ** * HQ SPECIALTY PHARMA CORP CISPLATIN, CISPLATIN TAXOL, PACLITAXEL HQ SPECIALITY PHARMA * HQ SPECIALITY PHARMA LLC LEVETIRACETAM IN SODIUM CHLORIDE, LEVETIRACETAM HQ SPECLT PHARMA * HQ SPECIALTY PHARMA VUMON, TENIPOSIDE HRA PHARMA * HRA PHARMA LLC METOPIRONE, METYRAPONE HYPERION THERAP INC * HYPERION THERAPEUTICS INC RAVICTI, GLYCEROL PHENYLBUTYRATE HYPERION THERAPS INC * HYPERION THERAPEUTICS INC BUPHENYL, SODIUM PHENYLBUTYRATE ROCHE * HOFFMANN LA ROCHE INC BONIVA, IBANDRONATE SODIUM COPEGUS, RIBAVIRIN FUZEON, ENFUVIRTIDE TAMIFLU, OSELTAMIVIR PHOSPHATE ** I ** IBI * ISTITUTO BIOCHIMICO ITALIANO SPA AMPICILLIN AND SULBACTAM, AMPICILLIN SODIUM AMPICILLIN SODIUM, AMPICILLIN SODIUM NAFCILLIN SODIUM, NAFCILLIN SODIUM PENICILLIN G POTASSIUM, PENICILLIN G POTASSIUM PIPERACILLIN AND TAZOBACTAM, PIPERACILLIN SODIUM PIPERACILLIN, PIPERACILLIN SODIUM IDENTI PHARMS INC * IDENTI PHARMACEUTICALS INC FLUOCINOLONE ACETONIDE, FLUOCINOLONE ACETONIDE IGI LABS INC * IGI LABORATORIES INC ECONAZOLE NITRATE, ECONAZOLE NITRATE 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 DIGOXIN, DIGOXIN DIPYRIDAMOLE, DIPYRIDAMOLE DIVALPROEX SODIUM, DIVALPROEX SODIUM FENOFIBRATE (MICRONIZED), FENOFIBRATE FENOFIBRATE, FENOFIBRATE FLUDROCORTISONE ACETATE, FLUDROCORTISONE ACETATE GALANTAMINE HYDROBROMIDE, GALANTAMINE HYDROBROMIDE LETROZOLE, LETROZOLE LORATADINE AND PSEUDOEPHEDRINE SULFATE, LORATADINE (OTC) B - 55 DECEMBER 2013 - APPROVED DRUG PRODUCT LIST APPENDIX B - PRODUCT NAME SORTED BY APPLICANT ** I ** * IMPAX LABORATORIES INC LORATADINE, LORATADINE (OTC) METFORMIN HYDROCHLORIDE, METFORMIN HYDROCHLORIDE MINOCYCLINE HYDROCHLORIDE, MINOCYCLINE HYDROCHLORIDE NADOLOL AND BENDROFLUMETHIAZIDE, BENDROFLUMETHIAZIDE OMEPRAZOLE, OMEPRAZOLE OXYMORPHONE HYDROCHLORIDE, OXYMORPHONE HYDROCHLORIDE 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 IMPAX LABS INC * IMPAX LABORATORIES INC CABERGOLINE, CABERGOLINE DOXYCYCLINE HYCLATE, DOXYCYCLINE HYCLATE DOXYCYCLINE, DOXYCYCLINE MINOCYCLINE HYDROCHLORIDE, MINOCYCLINE HYDROCHLORIDE IMPAX PHARMS * IMPAX PHARMACEUTICALS FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE, FLAVOXATE HYDROCHLORIDE, FLAVOXATE HYDROCHLORIDE GEMFIBROZIL, GEMFIBROZIL MIDODRINE HYDROCHLORIDE, MIDODRINE HYDROCHLORIDE OXYBUTYNIN CHLORIDE, OXYBUTYNIN CHLORIDE SOTALOL HYDROCHLORIDE, SOTALOL HYDROCHLORIDE INCYTE CORP * INCYTE CORP JAKAFI, RUXOLITINIB PHOSPHATE INDICUS PHARMA * INDICUS PHARMA LLC DONEPEZIL HYDROCHLORIDE, DONEPEZIL HYDROCHLORIDE LETROZOLE, LETROZOLE METFORMIN HYDROCHLORIDE, METFORMIN HYDROCHLORIDE INDOCO REMEDIES * INDOCO REMEDIES LTD GLIMEPIRIDE, GLIMEPIRIDE INJECTALIA * INJECTALIA SRL SUMATRIPTAN SUCCINATE, SUMATRIPTAN SUCCINATE INNOPHARMA LICENSING * INNOPHARMA LICENSING LLC ACETYLCYSTEINE, ACETYLCYSTEINE INSIGHT PHARMS * INSIGHT PHARMACEUTICALS CORP MONISTAT 1 COMBINATION PACK, MICONAZOLE NITRATE (OTC) MONISTAT 3 COMBINATION PACK (PREFILLED), MICONAZOLE NITRATE MONISTAT 3 COMBINATION PACK, MICONAZOLE NITRATE (OTC) MONISTAT 3, MICONAZOLE NITRATE MONISTAT 3, MICONAZOLE NITRATE (OTC) MONISTAT 7 COMBINATION PACK, MICONAZOLE NITRATE (OTC) MONISTAT 7, MICONAZOLE NITRATE (OTC) MONISTAT-3 COMBINATION PACK, MICONAZOLE NITRATE (OTC) NIX, PERMETHRIN (OTC) INST BIOCHEM * INSTITUT BIOCHEMIQUE SA FLECTOR, DICLOFENAC EPOLAMINE INST BIOCHIMIQUE * INSTITUTE BIOCHIMIQUE SA (IBSA) TIROSINT, LEVOTHYROXINE SODIUM INSTITUT BIOCHIMIQUE FEXOFENADINE (OTC) B - 56 DECEMBER 2013 - APPROVED DRUG PRODUCT LIST APPENDIX B - PRODUCT NAME SORTED BY APPLICANT ** I ** * INSTITUT BIOCHIMIQUE SA IBSA TIROSINT, LEVOTHYROXINE SODIUM INSYS THERAP * INSYS THERAPEUTICS INC DRONABINOL, DRONABINOL SUBSYS, FENTANYL INTELLIPHARMACEUTICS * INTELLIPHARMACEUTICS CORP DEXMETHYLPHENIDATE HYDROCHLORIDE, DEXMETHYLPHENIDATE HYDROCHLORIDE INTERGEL PHARM * INTERGEL PHARMACEUTICAL INC NIFEDIPINE, NIFEDIPINE INTL MEDICATED * INTERNATIONAL MEDICATED SYSTEMS LTD MILRINONE LACTATE, MILRINONE LACTATE INTL MEDICATION * INTERNATIONAL MEDICATION SYSTEM LIDOCAINE HYDROCHLORIDE, LIDOCAINE HYDROCHLORIDE NALOXONE HYDROCHLORIDE, NALOXONE HYDROCHLORIDE PHYTONADIONE, PHYTONADIONE * INTERNATIONAL MEDICATION SYSTEMS LTD DILTIAZEM HYDROCHLORIDE, DILTIAZEM HYDROCHLORIDE INTL MEDICATION SYS * INTERNATIONAL MEDICATION SYSTEMS LTD LORAZEPAM, LORAZEPAM INVAGEN PHARMS * INVAGEN PHARMACEUTICALS INC ALFUZOSIN HYDROCHLORIDE, ALFUZOSIN HYDROCHLORIDE AMLODIPINE BESYLATE, AMLODIPINE BESYLATE BENZTROPINE MESYLATE, BENZTROPINE MESYLATE CALCIUM ACETATE, CALCIUM ACETATE CARBINOXAMINE MALEATE, CARBINOXAMINE MALEATE CITALOPRAM HYDROBROMIDE, CITALOPRAM HYDROBROMIDE CYCLOBENZAPRINE HYDROCHLORIDE, CYCLOBENZAPRINE HYDROCHLORIDE ESCITALOPRAM OXALATE, ESCITALOPRAM OXALATE 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 LISINOPRIL, LISINOPRIL MEPROBAMATE, MEPROBAMATE NABUMETONE, NABUMETONE NAPROXEN, NAPROXEN ORPHENADRINE CITRATE, ORPHENADRINE CITRATE QUINAPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE QUINAPRIL HYDROCHLORIDE, QUINAPRIL HYDROCHLORIDE RAMIPRIL, RAMIPRIL RIZATRIPTAN BENZOATE, RIZATRIPTAN BENZOATE SERTRALINE HYDROCHLORIDE, SERTRALINE HYDROCHLORIDE TERBINAFINE HYDROCHLORIDE, TERBINAFINE HYDROCHLORIDE TOPIRAMATE, TOPIRAMATE TRANDOLAPRIL, TRANDOLAPRIL WARFARIN SODIUM, WARFARIN SODIUM ZOLPIDEM TARTRATE, ZOLPIDEM TARTRATE ZONISAMIDE, ZONISAMIDE INVENTIA HLTHCARE * INVENTIA HEALTHCARE PRIVATE LTD METFORMIN HYDROCHLORIDE, METFORMIN HYDROCHLORIDE IPCA LABS LTD * IPCA LABORATORIES LTD B - 57 DECEMBER 2013 - APPROVED DRUG PRODUCT LIST APPENDIX B - PRODUCT NAME SORTED BY APPLICANT ** I ** * IPCA LABORATORIES LTD ALLOPURINOL, ALLOPURINOL ATENOLOL, ATENOLOL CHLOROQUINE PHOSPHATE, CHLOROQUINE PHOSPHATE FUROSEMIDE, FUROSEMIDE HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE HYDROXYCHLOROQUINE SULFATE, HYDROXYCHLOROQUINE SULFATE LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE LOSARTAN POTASSIUM, LOSARTAN POTASSIUM METOCLOPRAMIDE HYDROCHLORIDE, METOCLOPRAMIDE HYDROCHLORIDE METOPROLOL TARTRATE, METOPROLOL TARTRATE PROPRANOLOL HYDROCHLORIDE, PROPRANOLOL HYDROCHLORIDE TRAMADOL HYDROCHLORIDE, TRAMADOL HYDROCHLORIDE WARFARIN SODIUM, WARFARIN SODIUM IPR * IPR PHARMACEUTICALS INC CRESTOR, ROSUVASTATIN CALCIUM ZOMIG, ZOLMITRIPTAN IPR PHARMS INC * IPR PHARMACEUTICALS INC CAPRELSA, VANDETANIB IPSEN INC * IPSEN BIOPHARMACEUTICALS INC INCRELEX, MECASERMIN RECOMBINANT IPSEN PHARMA * IPSEN PHARMA BIOTECH SAS SOMATULINE DEPOT, LANREOTIDE ACETATE IROKO PHARMS * IROKO PHARMACEUTICALS LLC INDOCIN, INDOMETHACIN IROKO PHARMS LLC * IROKO PHARMACEUTICALS LLC ZORVOLEX, DICLOFENAC ISO TEX * ISO TEX DIAGNOSTICS INC JEANATOPE, ALBUMIN IODINATED I-125 SERUM MEGATOPE, ALBUMIN IODINATED I-131 SERUM ISOTEX * ISOTEX DIAGNOSTICS GLOFIL-125, IOTHALAMATE SODIUM I-125 ISTA PHARMS INC * ISTA PHARMACEUTICALS INC BEPREVE, BEPOTASTINE BESILATE BROMDAY, BROMFENAC SODIUM ISTITUTO BIO ITA SPA * ISTITUTO BIOCHIMICO ITALIANO SPA AMPICILLIN SODIUM, AMPICILLIN SODIUM IVAX INTL * IVAX INTERNATIONAL GMBH AMRIX, CYCLOBENZAPRINE HYDROCHLORIDE SYNRIBO, OMACETAXINE MEPESUCCINATE IVAX PHARMS * IVAX PHARMACEUTICALS INC PERINDOPRIL ERBUMINE, PERINDOPRIL ERBUMINE IVAX SUB TEVA PHARMS * IVAX PHARMACEUTICALS INC SUB TEVA PHARMACEUTICALS USA ESCITALOPRAM OXALATE, ESCITALOPRAM OXALATE FLUTAMIDE, FLUTAMIDE GRISEOFULVIN, GRISEOFULVIN, MICROSIZE HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE OXAZEPAM, OXAZEPAM RANITIDINE HYDROCHLORIDE, RANITIDINE HYDROCHLORIDE (OTC) ** J ** B - 58 DECEMBER 2013 - APPROVED DRUG PRODUCT LIST APPENDIX B - PRODUCT NAME SORTED BY APPLICANT ** J ** JANSSEN BIOTECH * JANSSEN BIOTECH INC ZYTIGA, ABIRATERONE ACETATE JANSSEN PHARMS * JANSSEN PHARMACEUTICALS INC CONCERTA, METHYLPHENIDATE HYDROCHLORIDE INVEGA SUSTENNA, PALIPERIDONE PALMITATE INVOKANA, CANAGLIFLOZIN NUCYNTA ER, TAPENTADOL HYDROCHLORIDE NUCYNTA, TAPENTADOL HYDROCHLORIDE ORTHO EVRA, ETHINYL ESTRADIOL RISPERDAL, RISPERIDONE TOPAMAX, TOPIRAMATE XARELTO, RIVAROXABAN JANSSEN PRODS * JANSSEN PRODUCTS LP EDURANT, RILPIVIRINE HYDROCHLORIDE PREZISTA, DARUNAVIR ETHANOLATE JANSSEN R AND D * JANSSEN RESEARCH AND DEVELOPMENT LLC INTELENCE, ETRAVIRINE PARAFON FORTE DSC, CHLORZOXAZONE JANSSEN RES AND DEV * JANSSEN RESEARCH AND DEVELOPMENT LLC DOXIL (LIPOSOMAL), DOXORUBICIN HYDROCHLORIDE OLYSIO, SIMEPREVIR JANSSEN THERAP * JANSSEN THERAPEUTICS DIV JANSSEN PRODUCTS LP SIRTURO, BEDAQUILINE FUMARATE JAZZ PHARMS * JAZZ PHARMACEUTICALS INC LUVOX CR, FLUVOXAMINE MALEATE XYREM, SODIUM OXYBATE JAZZ PHARMS III * JAZZ PHARMACEUTICALS III INTERNATIONAL LTD FAZACLO ODT, CLOZAPINE * JAZZ PHARMACEUTICALS INTERNATIONAL III VERSACLOZ, CLOZAPINE JAZZ PHARMS INTL * JAZZ PHARMACEUTICALS INTERNATIONAL LTD PRIALT, ZICONOTIDE ACETATE JHP PHARMS * JHP PHARMACEUTICALS LLC ADRENALIN, EPINEPHRINE 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 JHP PHARMS LLC * JHP PHARMACEUTICALS LLC ADRENALIN, EPINEPHRINE ETOMIDATE, ETOMIDATE JIANGSU HANSOH PHARM * JIANGSU HANSOH PHARMACEUTICAL CO LTD GEMCITABINE HYDROCHLORIDE, GEMCITABINE HYDROCHLORIDE VINORELBINE TARTRATE, VINORELBINE TARTRATE JIANGSU HENGRUI MED * JIANGSU HENGRUI MEDICINE CO LTD B - 59 DECEMBER 2013 - APPROVED DRUG PRODUCT LIST APPENDIX B - PRODUCT NAME SORTED BY APPLICANT ** J ** * JIANGSU HENGRUI MEDICINE CO LTD IRINOTECAN HYDROCHLORIDE, IRINOTECAN HYDROCHLORIDE LETROZOLE, LETROZOLE JOHNSON AND JOHNSON * 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-A, NAPHAZOLINE HYDROCHLORIDE (OTC) * JOHNSON AND JOHNSON HEALTHCARE PRODUCTS VISINE L.R., OXYMETAZOLINE HYDROCHLORIDE (OTC) JUBILANT CADISTA * JUBILANT CADISTA PHARMACEUTICALS INC CYCLOBENZAPRINE HYDROCHLORIDE, CYCLOBENZAPRINE HYDROCHLORIDE FOLIC ACID, FOLIC ACID HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE MECLIZINE HYDROCHLORIDE, MECLIZINE HYDROCHLORIDE METHYLPREDNISOLONE, METHYLPREDNISOLONE PREDNISONE, PREDNISONE PROCOMP, PROCHLORPERAZINE MALEATE TERAZOSIN HYDROCHLORIDE, TERAZOSIN HYDROCHLORIDE JUBILANT DRAXIMAGE * JUBILANT DRAXIMAGE INC AN-DTPA, TECHNETIUM TC-99M PENTETATE KIT DRAXIMAGE MDP-25, TECHNETIUM TC-99M MEDRONATE HICON, SODIUM IODIDE I-131 PULMOLITE, TECHNETIUM TC-99M ALBUMIN AGGREGATED KIT SODIUM IODIDE I-131, SODIUM IODIDE I-131 JUBILANT LIFE * JUBILANT LIFE SCIENCES LTD BUPROPION HYDROCHLORIDE, BUPROPION HYDROCHLORIDE DONEPEZIL HYDROCHLORIDE, DONEPEZIL HYDROCHLORIDE LAMOTRIGINE, LAMOTRIGINE QUETIAPINE FUMARATE, QUETIAPINE FUMARATE JUBILANT ORGANOSYS * JUBILANT ORGANOSYS LTD ESCITALOPRAM OXALATE, ESCITALOPRAM OXALATE OLANZAPINE, OLANZAPINE PANTOPRAZOLE SODIUM, PANTOPRAZOLE SODIUM RISPERIDONE, RISPERIDONE VALACYCLOVIR HYDROCHLORIDE, VALACYCLOVIR HYDROCHLORIDE STEVENS J * JEROME STEVENS PHARMACEUTICALS INC DIGOXIN, DIGOXIN METHOCARBAMOL AND ASPIRIN, ASPIRIN UNITHROID, LEVOTHYROXINE SODIUM ** ** K ** KING PFIZER * KING PHARMACEUTICALS INC SUB PFIZER INC AVINZA, MORPHINE SULFATE KING PHARMS * KING PHARMACEUTICALS INC ALTACE, RAMIPRIL BICILLIN C-R 900/300, PENICILLIN G BENZATHINE BICILLIN C-R, PENICILLIN G BENZATHINE BICILLIN L-A, PENICILLIN G BENZATHINE CORGARD, NADOLOL CORZIDE, BENDROFLUMETHIAZIDE PENICILLIN G PROCAINE, PENICILLIN G PROCAINE SKELAXIN, METAXALONE SYNERCID, DALFOPRISTIN TIGAN, TRIMETHOBENZAMIDE HYDROCHLORIDE * KING PHARMACEUTICALS RESEARCH AND DEVELOPMENT INC SUB KING PHARMACEUTICALS INC B - 60 DECEMBER 2013 - APPROVED DRUG PRODUCT LIST APPENDIX B - PRODUCT NAME SORTED BY APPLICANT ** K ** * KING PHARMACEUTICALS RESEARCH AND DEVELOPMENT INC SUB KING PHARMACEUTICALS INC TAPAZOLE, METHIMAZOLE TUSSIGON, HOMATROPINE METHYLBROMIDE KING PHARMS R AND D * KING PHARMACEUTICALS RESEARCH AND DEVELOPMENT INC CYTOMEL, LIOTHYRONINE SODIUM LEVOXYL, LEVOTHYROXINE SODIUM ** * KING PHARMACEUTICALS RESEARCH DEVELOPMENT INC OXECTA, OXYCODONE HYDROCHLORIDE KOWA CO * KOWA CO LTD LIVALO, PITAVASTATIN CALCIUM KREITCHMAN PET CTR * KREITCHMAN PET CENTER AMMONIA N 13, AMMONIA N-13 KREMERS URBAN DEV * KREMERS URBAN DEVELOPMENT CO RABEPRAZOLE SODIUM, RABEPRAZOLE SODIUM KREMERS URBAN PHARMS * KREMERS URBAN PHARMACEUTICALS INC GLYCOLAX, POLYETHYLENE GLYCOL 3350 GLYCOLAX, POLYETHYLENE GLYCOL 3350 (OTC) ISOSORBIDE MONONITRATE, ISOSORBIDE MONONITRATE MONOKET, ISOSORBIDE MONONITRATE NITROGLYCERIN, NITROGLYCERIN OMEPRAZOLE, OMEPRAZOLE KRKA TOVARNA ZDRAVIL * KRKA TOVARNA ZDRAVIL DD NOVO MESTO LANSOPRAZOLE , LANSOPRAZOLE KUDCO IRELAND * KUDCO IRELAND LTD ATORVASTATIN CALCIUM, ATORVASTATIN CALCIUM LETROZOLE, LETROZOLE METHYLPHENIDATE HYDROCHLORIDE, METHYLPHENIDATE HYDROCHLORIDE MONTELUKAST SODIUM, MONTELUKAST SODIUM PANTOPRAZOLE SODIUM, PANTOPRAZOLE SODIUM KV PHARM * KV PHARMACEUTICAL CO CLINDESSE, CLINDAMYCIN PHOSPHATE EVAMIST, ESTRADIOL MAKENA, HYDROXYPROGESTERONE CAPROATE KVK TECH * KVK TECH INC BENZPHETAMINE HYDROCHLORIDE, BENZPHETAMINE HYDROCHLORIDE BETAXOLOL HYDROCHLORIDE, BETAXOLOL HYDROCHLORIDE CYCLOBENZAPRINE HYDROCHLORIDE, CYCLOBENZAPRINE HYDROCHLORIDE HYDROXYZINE HYDROCHLORIDE, HYDROXYZINE HYDROCHLORIDE KALEXATE, SODIUM POLYSTYRENE SULFONATE PHENDIMETRAZINE TARTRATE, PHENDIMETRAZINE TARTRATE PHENTERMINE HYDROCHLORIDE, PHENTERMINE HYDROCHLORIDE PROMETHAZINE HYDROCHLORIDE, PROMETHAZINE HYDROCHLORIDE ** L ** LAB HRA PHARMA * LABORATOIRE HRA PHARMA ELLA, ULIPRISTAL ACETATE LANDELA PHARM * LANDELA PHARMACEUTICAL ALBUTEROL SULFATE, ALBUTEROL SULFATE FLUOXETINE HYDROCHLORIDE, FLUOXETINE HYDROCHLORIDE IPRATROPIUM BROMIDE, IPRATROPIUM BROMIDE LANNETT * LANNETT CO INC DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE, ATROPINE SULFATE B - 61 DECEMBER 2013 - APPROVED DRUG PRODUCT LIST APPENDIX B - PRODUCT NAME SORTED BY APPLICANT ** L ** * LANNETT CO INC LANIAZID, ISONIAZID LANORINAL, ASPIRIN PHENTERMINE HYDROCHLORIDE, PHENTERMINE HYDROCHLORIDE PRIMIDONE, PRIMIDONE * LANNETT HOLDINGS INC BACLOFEN, BACLOFEN 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 PHENTERMINE HYDROCHLORIDE, PHENTERMINE HYDROCHLORIDE PILOCARPINE HYDROCHLORIDE, PILOCARPINE HYDROCHLORIDE RIFAMPIN, RIFAMPIN TERBUTALINE SULFATE, TERBUTALINE SULFATE URSODIOL, URSODIOL LANNETT HOLDINGS INC * LANNETT HOLDINGS INC BUTALBITAL, ACETAMINOPHEN AND CAFFEINE, ACETAMINOPHEN DIETHYLPROPION HYDROCHLORIDE, DIETHYLPROPION HYDROCHLORIDE HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE LOXAPINE SUCCINATE, LOXAPINE SUCCINATE METHOCARBAMOL, METHOCARBAMOL MORPHINE SULFATE, MORPHINE SULFATE PHENTERMINE HYDROCHLORIDE, PHENTERMINE HYDROCHLORIDE PHENTERMINE RESIN COMPLEX, PHENTERMINE RESIN COMPLEX TRIAMTERENE AND HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE LANTHEUS MEDCL * LANTHEUS MEDICAL IMAGING INC ABLAVAR, GADOFOSVESET TRISODIUM CARDIOLITE, TECHNETIUM TC-99M SESTAMIBI KIT 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 LANTHEUS MEDICAL * LANTHEUS MEDICAL IMAGING INC QUADRAMET, SAMARIUM SM-153 LEXIDRONAM PENTASODIUM LARKEN LABS * LARKEN LABORATORIES INC DOXYCYCLINE HYCLATE, DOXYCYCLINE HYCLATE LAVIPHARM LABS * LAVIPHARM LABORATORIES INC FENTANYL-100, FENTANYL FENTANYL-25, FENTANYL FENTANYL-50, FENTANYL FENTANYL-75, FENTANYL LEHIGH VALLEY * LEHIGH VALLEY TECHNOLOGIES INC OXYCODONE HYDROCHLORIDE, OXYCODONE HYDROCHLORIDE LEK PHARMS DD * LEK PHARMACEUTICALS DD ZOLPIDEM TARTRATE, ZOLPIDEM TARTRATE LEO PHARM * LEO PHARMACEUTICAL PRODUCTS LTD DOVONEX, CALCIPOTRIENE LEO PHARMA AS B - 62 DECEMBER 2013 - APPROVED DRUG PRODUCT LIST APPENDIX B - PRODUCT NAME SORTED BY APPLICANT ** L ** * LEO PHARMA AS DOVONEX, CALCIPOTRIENE PICATO, INGENOL MEBUTATE TACLONEX, BETAMETHASONE DIPROPIONATE LG LIFE * LG LIFE SCIENCES LTD VALTROPIN, SOMATROPIN RECOMBINANT LG LIFE SCIENCES * LG LIFE SCIENCES LTD FACTIVE, GEMIFLOXACIN MESYLATE LIAONING CHENGDA * LIAONING CHENGDA BIOTECHNOLOGY CO LTD ZIDOVUDINE, ZIDOVUDINE LLOYD * LLOYD INC LEVOTHROID, LEVOTHYROXINE SODIUM ** LNK * LNK INTERNATIONAL INC DOXYLAMINE SUCCINATE, DOXYLAMINE SUCCINATE (OTC) IBUPROFEN, IBUPROFEN (OTC) LOPERAMIDE HYDROCHLORIDE, LOPERAMIDE HYDROCHLORIDE (OTC) LOREAL USA * LOREAL USA PRODUCTS INC ANTHELIOS 20, AVOBENZONE (OTC) ANTHELIOS 40, AVOBENZONE (OTC) ANTHELIOS SX, AVOBENZONE (OTC) CAPITAL SOLEIL 15, AVOBENZONE (OTC) LOTUS PHARM CO LTD * LOTUS PHARMACEUTICAL CO LTD LEVETIRACETAM, LEVETIRACETAM LUITPOLD * LUITPOLD PHARMACEUTICALS INC ACETYLCYSTEINE, ACETYLCYSTEINE ADENOSINE, ADENOSINE BENZTROPINE MESYLATE, BENZTROPINE MESYLATE BETAMETHASONE ACETATE AND BETAMETHASONE SODIUM PHOSPHATE, BETAMETHASONE ACETATE BROMFENAC SODIUM, BROMFENAC SODIUM BUPRENORPHINE HYDROCHLORIDE, BUPRENORPHINE HYDROCHLORIDE CAFFEINE CITRATE, CAFFEINE CITRATE CALCITRIOL, CALCITRIOL CHLOROTHIAZIDE SODIUM, CHLOROTHIAZIDE SODIUM CLONIDINE HYDROCHLORIDE, CLONIDINE HYDROCHLORIDE CYANOCOBALAMIN, CYANOCOBALAMIN CYCLOSPORINE, CYCLOSPORINE DACTINOMYCIN, DACTINOMYCIN DEXAMETHASONE SODIUM PHOSPHATE, DEXAMETHASONE SODIUM PHOSPHATE DOPAMINE HYDROCHLORIDE, DOPAMINE HYDROCHLORIDE DORZOLAMIDE HYDROCHLORIDE, DORZOLAMIDE HYDROCHLORIDE EPINASTINE HYDROCHLORIDE, EPINASTINE HYDROCHLORIDE ESTRADIOL VALERATE, ESTRADIOL VALERATE ETOMIDATE, ETOMIDATE FOMEPIZOLE, FOMEPIZOLE FOSPHENYTOIN SODIUM, FOSPHENYTOIN SODIUM FUROSEMIDE, FUROSEMIDE GANCICLOVIR, GANCICLOVIR SODIUM GEMCITABINE HYDROCHLORIDE, GEMCITABINE HYDROCHLORIDE GRANISETRON HYDROCHLORIDE, GRANISETRON HYDROCHLORIDE IBUTILIDE FUMARATE, IBUTILIDE FUMARATE INJECTAFER, FERRIC CARBOXYMALTOSE LATANOPROST, LATANOPROST LEVETIRACETAM, LEVETIRACETAM LEVOCARNITINE, LEVOCARNITINE METHYLDOPATE HYDROCHLORIDE, METHYLDOPATE HYDROCHLORIDE METHYLERGONOVINE MALEATE, METHYLERGONOVINE MALEATE METOPROLOL TARTRATE, METOPROLOL TARTRATE B - 63 DECEMBER 2013 - APPROVED DRUG PRODUCT LIST APPENDIX B - PRODUCT NAME SORTED BY APPLICANT ** L ** * LUITPOLD PHARMACEUTICALS INC NEOMYCIN AND POLYMYXIN B SULFATES AND GRAMICIDIN, GRAMICIDIN NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE, HYDROCORTISONE NITROGLYCERIN, NITROGLYCERIN OLANZAPINE, OLANZAPINE ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE, ONDANSETRON HYDROCHLORIDE ONDANSETRON HYDROCHLORIDE, ONDANSETRON HYDROCHLORIDE PAMIDRONATE DISODIUM, PAMIDRONATE DISODIUM PHENYTOIN SODIUM, PHENYTOIN SODIUM PROGESTERONE, PROGESTERONE PROMETHAZINE HYDROCHLORIDE, PROMETHAZINE HYDROCHLORIDE SPRIX, KETOROLAC TROMETHAMINE TORSEMIDE, TORSEMIDE TRANEXAMIC ACID, TRANEXAMIC ACID TRIMETHOBENZAMIDE HYDROCHLORIDE PRESERVATIVE FREE, TRIMETHOBENZAMIDE HYDROCHLORIDE TRIMETHOBENZAMIDE HYDROCHLORIDE, TRIMETHOBENZAMIDE HYDROCHLORIDE VENOFER, IRON SUCROSE ZIDOVUDINE, ZIDOVUDINE LUKARE MEDICAL LLC * LUKARE MEDICAL LLC ELLIOTTS B SOLUTION, CALCIUM CHLORIDE LUNDBECK LLC * LUNDBECK LLC ONFI, CLOBAZAM SABRIL, VIGABATRIN LUPIN * LUPIN LTD AMLODIPINE BESYLATE, AMLODIPINE BESYLATE CARVEDILOL, CARVEDILOL CEFADROXIL, CEFADROXIL/CEFADROXIL HEMIHYDRATE CEFDINIR, CEFDINIR 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 LEVOFLOXACIN, LEVOFLOXACIN LISINOPRIL AND HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE LISINOPRIL, LISINOPRIL LOVASTATIN, LOVASTATIN QUINAPRIL HYDROCHLORIDE, QUINAPRIL HYDROCHLORIDE RAMIPRIL, RAMIPRIL SERTRALINE HYDROCHLORIDE, SERTRALINE HYDROCHLORIDE SIMVASTATIN, SIMVASTATIN TOPIRAMATE, TOPIRAMATE TRANDOLAPRIL, TRANDOLAPRIL LUPIN ATLANTIS * LUPIN ATLANTIS HOLDINGS SA ANTARA (MICRONIZED), FENOFIBRATE LUPIN LTD * LUPIN LIMITED LEVETIRACETAM, LEVETIRACETAM LEVONORGESTREL AND ETHINYL ESTRADIOL, ETHINYL ESTRADIOL * LUPIN LTD ABACAVIR SULFATE, LAMIVUDINE AND ZIDOVUDINE, ABACAVIR SULFATE DAYSEE, ETHINYL ESTRADIOL DOXYCYCLINE, DOXYCYCLINE DROSPIRENONE AND ETHINYL ESTRADIOL, DROSPIRENONE DULOXETINE HYDROCHLORIDE, DULOXETINE HYDROCHLORIDE ENSKYCE, DESOGESTREL ESCITALOPRAM OXALATE, ESCITALOPRAM OXALATE FAMOTIDINE, FAMOTIDINE B - 64 DECEMBER 2013 - APPROVED DRUG PRODUCT LIST APPENDIX B - PRODUCT NAME SORTED BY APPLICANT ** L ** * LUPIN LTD FENOFIBRATE, FENOFIBRATE FENOFIBRIC ACID, CHOLINE FENOFIBRATE GATIFLOXACIN, GATIFLOXACIN IMIPRAMINE HYDROCHLORIDE, IMIPRAMINE HYDROCHLORIDE IMIPRAMINE PAMOATE, IMIPRAMINE PAMOATE IRBESARTAN AND HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE IRBESARTAN, IRBESARTAN JENCYCLA, NORETHINDRONE KURVELO, ETHINYL ESTRADIOL LAMIVUDINE AND ZIDOVUDINE, LAMIVUDINE LAMOTRIGINE, LAMOTRIGINE LEVETIRACETAM, LEVETIRACETAM LEVONORGESTREL AND ETHINYL ESTRADIOL, ETHINYL ESTRADIOL LEVONORGESTREL, LEVONORGESTREL LEVONORGESTREL, LEVONORGESTREL (OTC) LORAZEPAM, LORAZEPAM LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE LOSARTAN POTASSIUM, LOSARTAN POTASSIUM MEFENAMIC ACID, MEFENAMIC ACID METFORMIN HYDROCHLORIDE, METFORMIN HYDROCHLORIDE MINOCYCLINE HYDROCHLORIDE, MINOCYCLINE HYDROCHLORIDE NABUMETONE, NABUMETONE NORETHINDRONE, NORETHINDRONE PERINDOPRIL ERBUMINE, PERINDOPRIL ERBUMINE PIRMELLA 1/35, ETHINYL ESTRADIOL PIRMELLA 7/7/7, ETHINYL ESTRADIOL PREGABALIN, PREGABALIN QUETIAPINE FUMARATE, QUETIAPINE FUMARATE RABEPRAZOLE SODIUM, RABEPRAZOLE SODIUM RANOLAZINE, RANOLAZINE SUPRAX, CEFIXIME TELMISARTAN AND AMLODIPINE, AMLODIPINE BESYLATE TRAMADOL HYDROCHLORIDE, TRAMADOL HYDROCHLORIDE VALSARTAN AND HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE VYFEMLA, ETHINYL ESTRADIOL ZOLPIDEM TARTRATE, ZOLPIDEM TARTRATE LUPIN PHARMS * LUPIN PHARMACEUTICALS INC AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE, AMLODIPINE BESYLATE DESLORATADINE, DESLORATADINE MELOXICAM, MELOXICAM NORGESTIMATE AND ETHINYL ESTRADIOL, ETHINYL ESTRADIOL PRAVASTATIN SODIUM, PRAVASTATIN SODIUM RIFAMPIN, RIFAMPIN SUPRAX, CEFIXIME ZIPRASIDONE HYDROCHLORIDE, ZIPRASIDONE HYDROCHLORIDE LYNE * LYNE LABORATORIES INC CHLORHEXIDINE GLUCONATE, CHLORHEXIDINE GLUCONATE CLINDAMYCIN PALMITATE HYDROCHLORIDE, CLINDAMYCIN PALMITATE HYDROCHLORIDE CYPROHEPTADINE HYDROCHLORIDE, CYPROHEPTADINE HYDROCHLORIDE DEXAMETHASONE, DEXAMETHASONE HYDROCORTISONE, HYDROCORTISONE LEVOCARNITINE, LEVOCARNITINE TRIAMCINOLONE ACETONIDE, TRIAMCINOLONE ACETONIDE LYNROSE LABS * LYNROSE LABS LLC CARBINOXAMINE MALEATE, CARBINOXAMINE MALEATE PERRIGO * L PERRIGO CO ACETAMINOPHEN, ASPIRIN AND CAFFEINE, ACETAMINOPHEN (OTC) CROMOLYN SODIUM, CROMOLYN SODIUM (OTC) FAMOTIDINE, FAMOTIDINE (OTC) IBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE, IBUPROFEN (OTC) B - 65 B - 66 DECEMBER 2013 - APPROVED DRUG PRODUCT LIST APPENDIX B - PRODUCT NAME SORTED BY APPLICANT ** L ** * L PERRIGO CO IBUPROFEN, IBUPROFEN (OTC) LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE, LOPERAMIDE HYDROCHLORIDE LORATADINE, LORATADINE (OTC) MICONAZOLE 3 COMBINATION PACK, MICONAZOLE NITRATE (OTC) MINOXIDIL EXTRA STRENGTH (FOR MEN), MINOXIDIL (OTC) NAPROXEN SODIUM AND PSEUDOEPHEDRINE HYDROCHLORIDE, NAPROXEN SODIUM RANITIDINE HYDROCHLORIDE, RANITIDINE HYDROCHLORIDE (OTC) TIOCONAZOLE, TIOCONAZOLE (OTC) ** M ** MACLEODS PHARMS LTD * MACLEODS PHARMACEUTICALS LTD AMLODIPINE BESYLATE, AMLODIPINE BESYLATE DONEPEZIL HYDROCHLORIDE, DONEPEZIL HYDROCHLORIDE ESCITALOPRAM OXALATE, ESCITALOPRAM OXALATE FAMCICLOVIR, FAMCICLOVIR IRBESARTAN AND HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE IRBESARTAN, IRBESARTAN LEVOFLOXACIN, LEVOFLOXACIN LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE LOSARTAN POTASSIUM, LOSARTAN POTASSIUM PANTOPRAZOLE SODIUM, PANTOPRAZOLE SODIUM PIOGLITAZONE HYDROCHLORIDE, PIOGLITAZONE HYDROCHLORIDE PRAMIPEXOLE DIHYDROCHLORIDE, PRAMIPEXOLE DIHYDROCHLORIDE SILDENAFIL CITRATE, SILDENAFIL CITRATE VALSARTAN AND HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE MALLINCKRODT * MALLINCKRODT CHEMICAL INC BUTALBITAL, ACETAMINOPHEN AND CAFFEINE, ACETAMINOPHEN HYDROCODONE BITARTRATE AND ACETAMINOPHEN, ACETAMINOPHEN METHADOSE, METHADONE HYDROCHLORIDE * MALLINCKRODT INC ANEXSIA 5/325, ACETAMINOPHEN ANEXSIA 7.5/325, ACETAMINOPHEN ANEXSIA, ACETAMINOPHEN DEXTROAMPHETAMINE SULFATE, DEXTROAMPHETAMINE SULFATE FENTANYL CITRATE, FENTANYL CITRATE FLUOXETINE HYDROCHLORIDE, FLUOXETINE HYDROCHLORIDE HYDROCODONE BITARTRATE AND ACETAMINOPHEN, ACETAMINOPHEN HYDROMORPHONE HYDROCHLORIDE, HYDROMORPHONE HYDROCHLORIDE METHADONE HYDROCHLORIDE, METHADONE HYDROCHLORIDE METHYLIN, METHYLPHENIDATE HYDROCHLORIDE MORPHINE SULFATE, MORPHINE SULFATE NALTREXONE HYDROCHLORIDE, NALTREXONE HYDROCHLORIDE OPTIMARK IN PLASTIC CONTAINER, GADOVERSETAMIDE OPTIMARK, GADOVERSETAMIDE OXYCODONE AND ACETAMINOPHEN, ACETAMINOPHEN PENNSAID, DICLOFENAC SODIUM SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, SODIUM CHLORIDE TECHNETIUM TC-99 SESTAMIBI, TECHNETIUM TC-99M SESTAMIBI KIT TRAMADOL HYDROCHLORIDE, TRAMADOL HYDROCHLORIDE * MALLINCKRODT MEDICAL INC GALLIUM CITRATE GA 67, GALLIUM CITRATE GA-67 INDIUM IN 111 CHLORIDE, INDIUM IN-111 CHLORIDE OCTREOSCAN, INDIUM IN-111 PENTETREOTIDE KIT OPTIRAY 300, 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, TECHNETIUM TC-99M OXIDRONATE KIT THALLOUS CHLORIDE TL 201, THALLOUS CHLORIDE TL-201 ULTRA-TECHNEKOW FM, TECHNETIUM TC-99M SODIUM PERTECHNETATE GENERATOR MALLINCKRODT INC * MALLINCKRODT INC (OTC) (OTC) B - 67 DECEMBER 2013 - APPROVED DRUG PRODUCT LIST APPENDIX B - PRODUCT NAME SORTED BY APPLICANT ** M ** * MALLINCKRODT INC ACETAMINOPHEN AND CODEINE PHOSPHATE, ACETAMINOPHEN BENZPHETAMINE HYDROCHLORIDE, BENZPHETAMINE HYDROCHLORIDE DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE, EXALGO, HYDROMORPHONE HYDROCHLORIDE FENTANYL-100, FENTANYL FENTANYL-25, FENTANYL FENTANYL-50, FENTANYL FENTANYL-75, FENTANYL GABLOFEN, BACLOFEN HYDROMORPHONE HYDROCHLORIDE, HYDROMORPHONE HYDROCHLORIDE METHADONE HYDROCHLORIDE, METHADONE HYDROCHLORIDE METHYLIN ER, METHYLPHENIDATE HYDROCHLORIDE METHYLPHENIDATE HYDROCHLORIDE, METHYLPHENIDATE HYDROCHLORIDE MORPHINE SULFATE, MORPHINE SULFATE OXYCODONE HYDROCHLORIDE, OXYCODONE HYDROCHLORIDE OXYMORPHONE HYDROCHLORIDE, OXYMORPHONE HYDROCHLORIDE RESTORIL, TEMAZEPAM ROXICODONE, OXYCODONE HYDROCHLORIDE TOFRANIL, IMIPRAMINE HYDROCHLORIDE TOFRANIL-PM, IMIPRAMINE PAMOATE MALLINCKRODT LLC * MALLINCKRODT LLC ANAFRANIL, CLOMIPRAMINE HYDROCHLORIDE PAMELOR, NORTRIPTYLINE HYDROCHLORIDE MARATHON PHARMS * MARATHON PHARMACEUTICALS LLC PEPCID, FAMOTIDINE SECONAL SODIUM, SECOBARBITAL SODIUM MARATHON PHARMS LLC * MARATHON PHARMACEUTICALS LLC IPRIVASK, DESIRUDIN RECOMBINANT MARKSANS PHARMA * MARKSANS PHARMA LTD GABAPENTIN, GABAPENTIN IBUPROFEN, IBUPROFEN IBUPROFEN, IBUPROFEN (OTC) METFORMIN HYDROCHLORIDE, METFORMIN HYDROCHLORIDE NAPROXEN SODIUM, NAPROXEN SODIUM (OTC) NAPROXEN, NAPROXEN MATRIX LABS LTD * MATRIX LABORATORIES LTD AMLODIPINE BESYLATE, AMLODIPINE BESYLATE NIFEDIPINE, NIFEDIPINE STAVUDINE, STAVUDINE MAYNE PHARMA * MAYNE PHARMA INTERNATIONAL PTY LTD DORYX, DOXYCYCLINE HYCLATE ERYC, ERYTHROMYCIN MCNEIL * MCNEIL CONSUMER PRODUCTS CO DIV MCNEILAB INC IMODIUM A-D EZ CHEWS, LOPERAMIDE HYDROCHLORIDE (OTC) IMODIUM MULTI-SYMPTOM RELIEF, LOPERAMIDE HYDROCHLORIDE (OTC) MOTRIN IB, IBUPROFEN (OTC) ZYRTEC-D 12 HOUR, CETIRIZINE HYDROCHLORIDE (OTC) MCNEIL CONS * MCNEIL CONSUMER HEALTHCARE 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) PEPCID AC , FAMOTIDINE (OTC) AMPHETAMINE DECEMBER 2013 - APPROVED DRUG PRODUCT LIST APPENDIX B - PRODUCT NAME SORTED BY APPLICANT ** M ** * MCNEIL CONSUMER HEALTHCARE PEPCID AC, FAMOTIDINE (OTC) PEPCID COMPLETE, CALCIUM CARBONATE (OTC) SINE-AID IB, IBUPROFEN (OTC) SUDAFED 12 HOUR, PSEUDOEPHEDRINE HYDROCHLORIDE (OTC) SUDAFED 24 HOUR, PSEUDOEPHEDRINE HYDROCHLORIDE (OTC) TYLENOL , 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 MCPRF * MAYO CLINIC PET RADIOCHEMISTRY FACILITY AMMONIA N 13, AMMONIA N-13 CHOLINE C-11, CHOLINE C-11 FLUDEOXYGLUCOSE F18, FLUDEOXYGLUCOSE F-18 SODIUM FLUORIDE F-18, SODIUM FLUORIDE F-18 MEDA PHARMS * MEDA PHARMACEUTICALS DYMISTA, AZELASTINE HYDROCHLORIDE EDLUAR, ZOLPIDEM TARTRATE * MEDA PHARMACEUTICALS INC ANADROL-50, OXYMETHOLONE ASTELIN, AZELASTINE HYDROCHLORIDE ASTEPRO, AZELASTINE HYDROCHLORIDE AVC, SULFANILAMIDE BUTISOL SODIUM, BUTABARBITAL SODIUM CESAMET, NABILONE COLYTE WITH FLAVOR PACKS, POLYETHYLENE GLYCOL 3350 COLYTE, POLYETHYLENE GLYCOL 3350 CORTIFOAM, HYDROCORTISONE ACETATE DEMADEX, TORSEMIDE DEPEN, PENICILLAMINE DIPENTUM, OLSALAZINE SODIUM ELESTRIN, ESTRADIOL EPIFOAM, HYDROCORTISONE ACETATE FELBATOL, FELBAMATE GASTROCROM, CROMOLYN SODIUM LUFYLLIN, DYPHYLLINE MUSE, ALPROSTADIL OPTIVAR, AZELASTINE HYDROCHLORIDE PROCTOFOAM HC, HYDROCORTISONE ACETATE ROWASA, MESALAMINE SFROWASA, MESALAMINE TRILYTE, POLYETHYLENE GLYCOL 3350 * MEDA PHARMACEUTICALS MEDA PHARMACEUTICALS INC SOMA COMPOUND W/ CODEINE, ASPIRIN SOMA COMPOUND, ASPIRIN SOMA, CARISOPRODOL MEDEFIL INC * MEDEFIL INC SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, SODIUM CHLORIDE SODIUM CHLORIDE 0.9%, SODIUM CHLORIDE MEDICIS * MEDICIS PHARMACEUTICAL CORP ALDARA, IMIQUIMOD CALCIUM DISODIUM VERSENATE, EDETATE CALCIUM DISODIUM DOXYCYCLINE HYCLATE, DOXYCYCLINE HYCLATE DYNACIN, MINOCYCLINE HYDROCHLORIDE ESTRASORB, ESTRADIOL HEMIHYDRATE LOPROX, CICLOPIROX LUZU, LULICONAZOLE B - 68 DECEMBER 2013 - APPROVED DRUG PRODUCT LIST APPENDIX B - PRODUCT NAME SORTED BY APPLICANT ** M * MEDICIS PHARMACEUTICAL CORP MAXAIR, PIRBUTEROL ACETATE METROGEL-VAGINAL, METRONIDAZOLE MINITRAN, NITROGLYCERIN NORFLEX, ORPHENADRINE CITRATE NORGESIC FORTE, ASPIRIN NORGESIC, ASPIRIN SOLODYN, MINOCYCLINE HYDROCHLORIDE THEOLAIR, THEOPHYLLINE VANOS, FLUOCINONIDE ZIANA, CLINDAMYCIN PHOSPHATE ZYCLARA, IMIQUIMOD MEDICURE * MEDICURE INTERNATIONAL INC AGGRASTAT, TIROFIBAN HYDROCHLORIDE MEDIGENE AG * MEDIGENE AG VEREGEN, SINECATECHINS MEDIMETRIKS PHARMS * MEDIMETRIKS PHARMACEUTICALS INC LOPROX, CICLOPIROX SYNALAR, FLUOCINOLONE ACETONIDE MEDIMMUNE * MEDIMMUNE ETHYOL, AMIFOSTINE MEDTECH PRODS * MEDTECH PRODUCTS INC TAGAMET HB, CIMETIDINE (OTC) MEDTRONIC NEURO * MEDTRONIC NEUROMODULATION LIORESAL, BACLOFEN MERCK * MERCK AND CO INC CANCIDAS, CASPOFUNGIN ACETATE EMEND, APREPITANT FOSAMAX PLUS D, ALENDRONATE SODIUM FOSAMAX, ALENDRONATE SODIUM MAXALT, RIZATRIPTAN BENZOATE MAXALT-MLT, RIZATRIPTAN BENZOATE PRIMAXIN, CILASTATIN SODIUM PROSCAR, FINASTERIDE SINGULAIR, MONTELUKAST SODIUM ZOLINZA, VORINOSTAT * MERCK RESEARCH LABORATORIES DIV MERCK CO INC PROPECIA, FINASTERIDE SINGULAIR, MONTELUKAST SODIUM TRUSOPT, DORZOLAMIDE HYDROCHLORIDE ZOCOR, SIMVASTATIN MERCK AND CO INC * MERCK AND CO INC EMEND, FOSAPREPITANT DIMEGLUMINE FOSAMAX, ALENDRONATE SODIUM MERCK SANTE SAS * MERCK SANTE SAS CYANOKIT, HYDROXOCOBALAMIN MERCK SHARP DOHME * MERCK SHARP AND DOHME CORP CELESTONE SOLUSPAN, BETAMETHASONE ACETATE CLARINEX D 24 HOUR, DESLORATADINE CLARINEX, DESLORATADINE CLARINEX-D 12 HOUR, DESLORATADINE COZAAR, LOSARTAN POTASSIUM CRIXIVAN, INDINAVIR SULFATE DIPROLENE AF, BETAMETHASONE DIPROPIONATE ** B - 69 DECEMBER 2013 - APPROVED DRUG PRODUCT LIST APPENDIX B - PRODUCT NAME SORTED BY APPLICANT ** M ** * MERCK SHARP AND DOHME CORP DIPROLENE, BETAMETHASONE DIPROPIONATE DULERA, FORMOTEROL FUMARATE ELOCON, MOMETASONE FUROATE GUANIDINE HYDROCHLORIDE, GUANIDINE HYDROCHLORIDE HYZAAR, HYDROCHLOROTHIAZIDE INVANZ, ERTAPENEM SODIUM ISENTRESS, RALTEGRAVIR POTASSIUM JANUMET XR, METFORMIN HYDROCHLORIDE JANUMET, METFORMIN HYDROCHLORIDE JANUVIA, SITAGLIPTIN PHOSPHATE LIPTRUZET, ATORVASTATIN CALCIUM LOTRISONE, BETAMETHASONE DIPROPIONATE NITRO-DUR, NITROGLYCERIN NOXAFIL, POSACONAZOLE REBETOL, RIBAVIRIN SINEMET CR, CARBIDOPA SINEMET, CARBIDOPA STROMECTOL, IVERMECTIN TEMODAR, TEMOZOLOMIDE VICTRELIS, BOCEPREVIR ZIOPTAN, TAFLUPROST MERIDIAN MEDCL * MERIDIAN MEDICAL TECHNOLOGIES INC DUODOTE, ATROPINE * MERIDIAN MEDICAL TECHNOLOGIES INC SUB KING PHARMACEUTICALS INC ALSUMA, SUMATRIPTAN SUCCINATE MERIDIAN MEDCL TECHN * MERIDIAN MEDICAL TECHNOLOGIES INC ATROPEN, ATROPINE MERRO PHARM * MERRO PHARMACEUTICAL CO LTD IBUPROFEN, IBUPROFEN (OTC) MERZ PHARMS * MERZ PHARMACEUTICALS LLC CUVPOSA, GLYCOPYRROLATE NAFTIN, NAFTIFINE HYDROCHLORIDE ONMEL, ITRACONAZOLE METHAPHARM * METHAPHARM INC LEVETIRACETAM, LEVETIRACETAM PROVOCHOLINE, METHACHOLINE CHLORIDE MICRO LABS LTD * MICRO LABS LTD MEFENAMIC ACID, MEFENAMIC ACID NEVIRAPINE, NEVIRAPINE SIMVASTATIN, SIMVASTATIN MICRO LABS LTD INDIA * MICRO LABS LTD INDIA CROMOLYN SODIUM, CROMOLYN SODIUM GLIMEPIRIDE, GLIMEPIRIDE LEVOCETIRIZINE DIHYDROCHLORIDE, LEVOCETIRIZINE DIHYDROCHLORIDE LOSARTAN POTASSIUM, LOSARTAN POTASSIUM TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN, ACETAMINOPHEN MIKAH PHARMA * MIKAH PHARMA LLC DANTROLENE SODIUM, DANTROLENE SODIUM ISRADIPINE, ISRADIPINE LOXAPINE SUCCINATE, LOXAPINE SUCCINATE PHENDIMETRAZINE TARTRATE, PHENDIMETRAZINE TARTRATE TRIMIPRAMINE MALEATE, TRIMIPRAMINE MALEATE MIKART * MIKART INC AMANTADINE HYDROCHLORIDE, AMANTADINE HYDROCHLORIDE AMINOCAPROIC, AMINOCAPROIC ACID B - 70 DECEMBER 2013 - APPROVED DRUG PRODUCT LIST APPENDIX B - PRODUCT NAME SORTED BY APPLICANT ** M ** * MIKART INC BENZONATATE, BENZONATATE BENZPHETAMINE HYDROCHLORIDE, BENZPHETAMINE HYDROCHLORIDE BUTALBITAL, ACETAMINOPHEN AND CAFFEINE, ACETAMINOPHEN BUTAPAP, ACETAMINOPHEN CARBINOXAMINE MALEATE, CARBINOXAMINE MALEATE CHLORZOXAZONE, CHLORZOXAZONE DEXTROAMPHETAMINE SULFATE, DEXTROAMPHETAMINE SULFATE DICYCLOMINE HYDROCHLORIDE, DICYCLOMINE HYDROCHLORIDE ERGOTAMINE TARTRATE AND CAFFEINE, CAFFEINE ESGIC-PLUS, ACETAMINOPHEN ETHOSUXIMIDE, ETHOSUXIMIDE HYDROCODONE BITARTRATE AND ACETAMINOPHEN, ACETAMINOPHEN MEPERIDINE HYDROCHLORIDE, MEPERIDINE HYDROCHLORIDE METHAZOLAMIDE, METHAZOLAMIDE OXYCODONE AND ACETAMINOPHEN, ACETAMINOPHEN PHENDIMETRAZINE TARTRATE, PHENDIMETRAZINE TARTRATE MILLENNIUM PHARMS * MILLENNIUM PHARMACEUTICALS INC VELCADE, BORTEZOMIB MIRROR PHARMS * MIRROR PHARMACEUTICALS LLC BUTALBITAL, ACETAMINOPHEN AND CAFFEINE, ACETAMINOPHEN CARISOPRODOL AND ASPIRIN, ASPIRIN CARISOPRODOL, ASPIRIN AND CODEINE PHOSPHATE, ASPIRIN CARISOPRODOL, CARISOPRODOL PHENTERMINE HYDROCHLORIDE, PHENTERMINE HYDROCHLORIDE PROBENECID AND COLCHICINE, COLCHICINE MISSION PHARMA * MISSION PHARMACAL CO BINOSTO, ALENDRONATE SODIUM PREDNISOLONE SODIUM PHOSPHATE, PREDNISOLONE SODIUM PHOSPHATE TEXACORT, HYDROCORTISONE THIOLA, TIOPRONIN TINDAMAX, TINIDAZOLE UROCIT-K, POTASSIUM CITRATE MIST PHARMS LLC * MIST PHARMACEUTICALS LLC NITROMIST, NITROGLYCERIN MN PHARMS * MN PHARMACEUTICALS PAMIDRONATE DISODIUM, PAMIDRONATE DISODIUM MOBIUS THERAP * MOBIUS THERAPEUTICS LLC MITOSOL, MITOMYCIN MOLNLYCKE HLTH * MOLNLYCKE HEALTH CARE HIBICLENS, CHLORHEXIDINE GLUCONATE (OTC) HIBISTAT, CHLORHEXIDINE GLUCONATE (OTC) MONARCH PHARMS * MONARCH PHARMACEUTICALS INC MENEST, ESTROGENS, ESTERIFIED NEOSPORIN G.U. IRRIGANT, NEOMYCIN SULFATE MSD CONSUMER * MSD CONSUMER CARE INC OXYTROL FOR WOMEN, OXYBUTYNIN (OTC) ZEGERID OTC, OMEPRAZOLE (OTC) MSD INTL * MSD INTERNATIONAL GMBH VYTORIN, EZETIMIBE MSD INTL GMBH * MSD INTERNATIONAL GMBH ZETIA, EZETIMIBE MURTY PHARMS B - 71 DECEMBER 2013 - APPROVED DRUG PRODUCT LIST APPENDIX B - B - 72 PRODUCT NAME SORTED BY APPLICANT ** M ** * MURTY PHARMACEUTICALS INC AMIODARONE HYDROCHLORIDE, AMIODARONE HYDROCHLORIDE DIPYRIDAMOLE, DIPYRIDAMOLE MUSTAFA NEVSAT * MUSTAFA NEVSAT ILAC SANAYII AS EPIRUBICIN HYDROCHLORIDE, EPIRUBICIN HYDROCHLORIDE METHYLPREDNISOLONE SODIUM SUCCINATE, METHYLPREDNISOLONE SODIUM SUCCINATE MUSTAFA NEVZAT * MUSTAFA NEVZAT ILAC SANAYII AS PAMIDRONATE DISODIUM, PAMIDRONATE DISODIUM VECURONIUM BROMIDE, VECURONIUM BROMIDE MUTUAL PHARM * MUTUAL PHARMACEUTICAL CO INC ALBUTEROL SULFATE, ALBUTEROL SULFATE BACTRIM DS, SULFAMETHOXAZOLE BACTRIM, SULFAMETHOXAZOLE CLONIDINE HYDROCHLORIDE, CLONIDINE HYDROCHLORIDE CLOPIDOGREL BISULFATE, CLOPIDOGREL BISULFATE CYCLOBENZAPRINE HYDROCHLORIDE, CYCLOBENZAPRINE HYDROCHLORIDE DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE, AMPHETAMINE FELODIPINE, FELODIPINE LOVASTATIN, LOVASTATIN METOCLOPRAMIDE HYDROCHLORIDE, METOCLOPRAMIDE HYDROCHLORIDE METOPROLOL TARTRATE, METOPROLOL TARTRATE PHENTERMINE HYDROCHLORIDE, PHENTERMINE HYDROCHLORIDE PRIMIDONE, PRIMIDONE PROPAFENONE HYDROCHLORIDE, PROPAFENONE HYDROCHLORIDE QUINIDINE GLUCONATE, QUINIDINE GLUCONATE QUINIDINE SULFATE, QUINIDINE SULFATE SPIRONOLACTONE, SPIRONOLACTONE TEMAZEPAM, TEMAZEPAM THIORIDAZINE HYDROCHLORIDE, THIORIDAZINE HYDROCHLORIDE TRAMADOL HYDROCHLORIDE, TRAMADOL HYDROCHLORIDE TRAZODONE HYDROCHLORIDE, TRAZODONE HYDROCHLORIDE MUTUAL PHARM CO INC * MUTUAL PHARMACEUTICAL CO INC FIBRICOR, FENOFIBRIC ACID IBANDRONATE SODIUM, IBANDRONATE SODIUM LEVETIRACETAM, LEVETIRACETAM QUALAQUIN, QUININE SULFATE MUTUAL PHARMA * MUTUAL PHARMACAL CO DOXYCYCLINE HYCLATE, DOXYCYCLINE HYCLATE METFORMIN HYDROCHLORIDE, METFORMIN HYDROCHLORIDE TRIMETHOBENZAMIDE HYDROCHLORIDE, TRIMETHOBENZAMIDE HYDROCHLORIDE MYLAN * MYLAN LABORATORIES INC ACYCLOVIR, ACYCLOVIR AMLODIPINE BESYLATE, AMLODIPINE BESYLATE ANAGRELIDE HYDROCHLORIDE, ANAGRELIDE HYDROCHLORIDE OLANZAPINE, OLANZAPINE * MYLAN PHARMACEUTICALS METOPROLOL TARTRATE AND HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE * MYLAN PHARMACEUTICALS INC ACARBOSE, ACARBOSE ACYCLOVIR, ACYCLOVIR ALBUTEROL SULFATE, ALBUTEROL SULFATE ALENDRONATE SODIUM, ALENDRONATE SODIUM ALFUZOSIN HYDROCHLORIDE, ALFUZOSIN HYDROCHLORIDE ALPRAZOLAM, ALPRAZOLAM AMILORIDE HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE, AMILORIDE HYDROCHLORIDE AMIODARONE HYDROCHLORIDE, AMIODARONE HYDROCHLORIDE AMITRIPTYLINE HYDROCHLORIDE, AMITRIPTYLINE HYDROCHLORIDE AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE, AMLODIPINE BESYLATE ANASTROZOLE, ANASTROZOLE DECEMBER 2013 - APPROVED DRUG PRODUCT LIST APPENDIX B - PRODUCT NAME SORTED BY APPLICANT ** M ** * MYLAN PHARMACEUTICALS INC ATENOLOL, ATENOLOL AVITA, TRETINOIN 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 BUDESONIDE, BUDESONIDE BUPROPION HYDROCHLORIDE, BUPROPION HYDROCHLORIDE BUSPIRONE HYDROCHLORIDE, BUSPIRONE HYDROCHLORIDE BUTORPHANOL TARTRATE, BUTORPHANOL TARTRATE CARBIDOPA AND LEVODOPA, CARBIDOPA CARVEDILOL, CARVEDILOL CETIRIZINE HYDROCHLORIDE ALLERGY, CETIRIZINE HYDROCHLORIDE (OTC) CETIRIZINE HYDROCHLORIDE HIVES, CETIRIZINE HYDROCHLORIDE (OTC) CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY, FEXOFENADINE HYDROCHLORIDE (OTC) CHILDREN'S FEXOFENADINE HYDROCHLORIDE HIVES, FEXOFENADINE HYDROCHLORIDE (OTC) CHLOROTHIAZIDE, CHLOROTHIAZIDE CHLORPROPAMIDE, CHLORPROPAMIDE CHLORTHALIDONE, CHLORTHALIDONE CILOSTAZOL, CILOSTAZOL CIPROFLOXACIN HYDROCHLORIDE, CIPROFLOXACIN HYDROCHLORIDE CITALOPRAM HYDROBROMIDE, CITALOPRAM HYDROBROMIDE CLARITHROMYCIN, CLARITHROMYCIN CLONIDINE HYDROCHLORIDE, CLONIDINE HYDROCHLORIDE CLORAZEPATE DIPOTASSIUM, CLORAZEPATE DIPOTASSIUM CLORPRES, CHLORTHALIDONE CYCLOBENZAPRINE HYDROCHLORIDE, CYCLOBENZAPRINE HYDROCHLORIDE DIAZEPAM, DIAZEPAM DICLOFENAC SODIUM, DICLOFENAC SODIUM DILTIAZEM HYDROCHLORIDE, DILTIAZEM HYDROCHLORIDE DIVALPROEX SODIUM, DIVALPROEX SODIUM DOXAZOSIN MESYLATE, DOXAZOSIN MESYLATE DOXYCYCLINE HYCLATE, DOXYCYCLINE HYCLATE DOXYCYCLINE, DOXYCYCLINE ENALAPRIL MALEATE AND HYDROCHLOROTHIAZIDE, ENALAPRIL MALEATE ESTROPIPATE, ESTROPIPATE ETIDRONATE DISODIUM, ETIDRONATE DISODIUM ETOPOSIDE, ETOPOSIDE EXTENDED PHENYTOIN SODIUM, PHENYTOIN SODIUM FAMCICLOVIR, FAMCICLOVIR FAMOTIDINE, FAMOTIDINE FAMOTIDINE, FAMOTIDINE (OTC) FELODIPINE, FELODIPINE FENOFIBRATE, FENOFIBRATE FEXOFENADINE HYDROCHLORIDE ALLERGY, FEXOFENADINE HYDROCHLORIDE (OTC) FEXOFENADINE HYDROCHLORIDE HIVES, FEXOFENADINE HYDROCHLORIDE (OTC) FEXOFENADINE HYDROCHLORIDE, FEXOFENADINE HYDROCHLORIDE FINASTERIDE, FINASTERIDE FLUCONAZOLE, FLUCONAZOLE FLUOXETINE HYDROCHLORIDE, FLUOXETINE HYDROCHLORIDE FLUPHENAZINE HYDROCHLORIDE, FLUPHENAZINE HYDROCHLORIDE FLUTAMIDE, FLUTAMIDE FLUVOXAMINE MALEATE, FLUVOXAMINE MALEATE GABAPENTIN, GABAPENTIN GALANTAMINE HYDROBROMIDE, GALANTAMINE HYDROBROMIDE GLIMEPIRIDE, GLIMEPIRIDE GLIPIZIDE AND METFORMIN HYDROCHLORIDE, GLIPIZIDE GLIPIZIDE, GLIPIZIDE B - 73 DECEMBER 2013 - APPROVED DRUG PRODUCT LIST APPENDIX B - B - 74 PRODUCT NAME SORTED BY APPLICANT ** M ** * MYLAN PHARMACEUTICALS INC GRANISETRON HYDROCHLORIDE, GRANISETRON HYDROCHLORIDE HALOPERIDOL, HALOPERIDOL HYDRALAZINE HYDROCHLORIDE, HYDRALAZINE HYDROCHLORIDE HYDROXYZINE HYDROCHLORIDE, HYDROXYZINE HYDROCHLORIDE INDAPAMIDE, INDAPAMIDE INDOMETHACIN, INDOMETHACIN KETOPROFEN, KETOPROFEN KETOROLAC TROMETHAMINE, KETOROLAC TROMETHAMINE LAMOTRIGINE, LAMOTRIGINE LATANOPROST, LATANOPROST LETROZOLE, LETROZOLE LEVETIRACETAM, LEVETIRACETAM LEVOFLOXACIN, LEVOFLOXACIN LEVOTHYROXINE SODIUM, LEVOTHYROXINE SODIUM ** LIOTHYRONINE SODIUM, LIOTHYRONINE SODIUM LISINOPRIL AND HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE LISINOPRIL, LISINOPRIL LORATADINE, LORATADINE (OTC) LORAZEPAM, LORAZEPAM LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE LOSARTAN POTASSIUM, LOSARTAN POTASSIUM LOVASTATIN, LOVASTATIN LOXAPINE SUCCINATE, LOXAPINE SUCCINATE MAPROTILINE HYDROCHLORIDE, MAPROTILINE HYDROCHLORIDE MECLOFENAMATE SODIUM, MECLOFENAMATE SODIUM MELOXICAM, MELOXICAM MENTAX, BUTENAFINE HYDROCHLORIDE MENTAX-TC, BUTENAFINE HYDROCHLORIDE MERCAPTOPURINE, MERCAPTOPURINE METFORMIN HYDROCHLORIDE, METFORMIN HYDROCHLORIDE METHIMAZOLE, METHIMAZOLE METHYLDOPA AND HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE METHYLDOPA, METHYLDOPA METOLAZONE, METOLAZONE METOPROLOL TARTRATE, METOPROLOL TARTRATE MIRTAZAPINE, MIRTAZAPINE MYCOPHENOLATE MOFETIL, MYCOPHENOLATE MOFETIL NADOLOL AND BENDROFLUMETHAZIDE, BENDROFLUMETHIAZIDE NIFEDIPINE, NIFEDIPINE NISOLDIPINE, NISOLDIPINE NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS), NITROFURANTOIN NITROFURANTOIN, NITROFURANTOIN, MACROCRYSTALLINE 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 PERPHENAZINE AND AMITRIPTYLINE HYDROCHLORIDE, AMITRIPTYLINE HYDROCHLORIDE PHENYTEK, PHENYTOIN SODIUM PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE, METFORMIN HYDROCHLORIDE POLYETHYLENE GLYCOL 3350, POLYETHYLENE GLYCOL 3350 (OTC) PRAMIPEXOLE DIHYDROCHLORIDE, PRAMIPEXOLE DIHYDROCHLORIDE PRAVASTATIN SODIUM, PRAVASTATIN SODIUM PRAZOSIN HYDROCHLORIDE, PRAZOSIN HYDROCHLORIDE PROMETHAZINE HYDROCHLORIDE, PROMETHAZINE HYDROCHLORIDE PROPRANOLOL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE PROPRANOLOL HYDROCHLORIDE, PROPRANOLOL HYDROCHLORIDE QUINAPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE QUINAPRIL HYDROCHLORIDE, QUINAPRIL HYDROCHLORIDE RANITIDINE HYDROCHLORIDE, RANITIDINE HYDROCHLORIDE RANITIDINE HYDROCHLORIDE, RANITIDINE HYDROCHLORIDE (OTC) DECEMBER 2013 - APPROVED DRUG PRODUCT LIST APPENDIX B - PRODUCT NAME SORTED BY APPLICANT ** M ** * MYLAN PHARMACEUTICALS INC RISPERIDONE, RISPERIDONE ROPINIROLE HYDROCHLORIDE, ROPINIROLE HYDROCHLORIDE SELEGILINE HYDROCHLORIDE, SELEGILINE HYDROCHLORIDE SERTRALINE HYDROCHLORIDE, SERTRALINE HYDROCHLORIDE SOTALOL HYDROCHLORIDE, SOTALOL HYDROCHLORIDE SPIRONOLACTONE, SPIRONOLACTONE STAVUDINE, STAVUDINE SULINDAC, SULINDAC SUMATRIPTAN SUCCINATE, SUMATRIPTAN SUCCINATE TACROLIMUS, TACROLIMUS TAMOXIFEN CITRATE, TAMOXIFEN CITRATE TAMSULOSIN HYDROCHLORIDE, TAMSULOSIN HYDROCHLORIDE TEMAZEPAM, TEMAZEPAM TERBINAFINE HYDROCHLORIDE, TERBINAFINE HYDROCHLORIDE THIORIDAZINE HYDROCHLORIDE, THIORIDAZINE HYDROCHLORIDE THIOTHIXENE, THIOTHIXENE TIMOLOL MALEATE, TIMOLOL MALEATE TIZANIDINE HYDROCHLORIDE, TIZANIDINE HYDROCHLORIDE TOLMETIN SODIUM, TOLMETIN SODIUM TOPIRAMATE, TOPIRAMATE TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN, ACETAMINOPHEN TRAMADOL HYDROCHLORIDE, TRAMADOL HYDROCHLORIDE TRANDOLAPRIL, TRANDOLAPRIL TRIFLUOPERAZINE HYDROCHLORIDE, TRIFLUOPERAZINE HYDROCHLORIDE URSODIOL, URSODIOL VALACYCLOVIR HYDROCHLORIDE, VALACYCLOVIR HYDROCHLORIDE VENLAFAXINE HYDROCHLORIDE, VENLAFAXINE HYDROCHLORIDE VERAPAMIL HYDROCHLORIDE, VERAPAMIL HYDROCHLORIDE WARFARIN SODIUM, WARFARIN SODIUM ZALEPLON, ZALEPLON ZOLPIDEM TARTRATE, ZOLPIDEM TARTRATE ZONISAMIDE, ZONISAMIDE MYLAN INSTITUTIONAL * MYLAN INSTITUTIONAL INC SULFAMYLON, MAFENIDE ACETATE * MYLAN INSTITUTIONAL LLC ALOPRIM, ALLOPURINOL SODIUM AMIODARONE HYDROCHLORIDE, AMIODARONE HYDROCHLORIDE AMPICILLIN AND SULBACTAM, AMPICILLIN SODIUM CARBOPLATIN, CARBOPLATIN CIDOFOVIR, CIDOFOVIR COSYNTROPIN, COSYNTROPIN DEXRAZOXANE HYDROCHLORIDE, DEXRAZOXANE HYDROCHLORIDE DIMETHYL SULFOXIDE, DIMETHYL SULFOXIDE DIPHENHYDRAMINE HYDROCHLORIDE, DIPHENHYDRAMINE HYDROCHLORIDE DOLOPHINE HYDROCHLORIDE, METHADONE HYDROCHLORIDE DURACLON, CLONIDINE HYDROCHLORIDE ENLON, EDROPHONIUM CHLORIDE ENLON-PLUS, ATROPINE SULFATE ESMOLOL HYDROCHLORIDE, ESMOLOL HYDROCHLORIDE FLUDARABINE PHOSPHATE, FLUDARABINE PHOSPHATE FOMEPIZOLE, FOMEPIZOLE IBUTILIDE FUMARATE, IBUTILIDE FUMARATE IRINOTECAN HYDROCHLORIDE, IRINOTECAN HYDROCHLORIDE ISOSULFAN BLUE, ISOSULFAN BLUE KETAMINE HYDROCHLORIDE, KETAMINE HYDROCHLORIDE MEFOXIN IN PLASTIC CONTAINER, CEFOXITIN SODIUM MELPHALAN HYDROCHLORIDE, MELPHALAN HYDROCHLORIDE MESNA, MESNA MITOXANTRONE HYDROCHLORIDE, MITOXANTRONE HYDROCHLORIDE NICARDIPINE HYDROCHLORIDE, NICARDIPINE HYDROCHLORIDE OCTREOTIDE ACETATE (PRESERVATIVE FREE), OCTREOTIDE ACETATE RIMSO-50, DIMETHYL SULFOXIDE ROCURONIUM BROMIDE, ROCURONIUM BROMIDE B - 75 DECEMBER 2013 - APPROVED DRUG PRODUCT LIST APPENDIX B - PRODUCT NAME SORTED BY APPLICANT ** M ** * MYLAN INSTITUTIONAL LLC SOTRADECOL, SODIUM TETRADECYL SULFATE TESTOSTERONE CYPIONATE, TESTOSTERONE CYPIONATE TESTOSTERONE ENANTHATE, TESTOSTERONE ENANTHATE THIAMINE HYDROCHLORIDE, THIAMINE HYDROCHLORIDE TOPOTECAN HYDROCHLORIDE, TOPOTECAN HYDROCHLORIDE TRANEXAMIC ACID, TRANEXAMIC ACID ULTIVA, REMIFENTANIL HYDROCHLORIDE VANCOMYCIN HYDROCHLORIDE, VANCOMYCIN HYDROCHLORIDE MYLAN LABS * MYLAN LABORATORIES LTD CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE, CANDESARTAN CILEXETIL NEVIRAPINE, NEVIRAPINE MYLAN PHARMS INC * MYLAN PHARMACEUTICALS INC ABACAVIR SULFATE, ABACAVIR SULFATE ACYCLOVIR, ACYCLOVIR ALPRAZOLAM, ALPRAZOLAM AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM, AMLODIPINE BESYLATE AMNESTEEM, ISOTRETINOIN ANAGRELIDE HYDROCHLORIDE, ANAGRELIDE HYDROCHLORIDE ARMODAFINIL, ARMODAFINIL ATORVASTATIN CALCIUM, ATORVASTATIN CALCIUM AVITA, TRETINOIN BACLOFEN, BACLOFEN CABERGOLINE, CABERGOLINE CHLORDIAZEPOXIDE AND AMITRIPTYLINE HYDROCHLORIDE, AMITRIPTYLINE HYDROCHLORIDE CILOSTAZOL, CILOSTAZOL CIPROFLOXACIN EXTENDED RELEASE, CIPROFLOXACIN CITALOPRAM HYDROBROMIDE, CITALOPRAM HYDROBROMIDE CLINDAMYCIN HYDROCHLORIDE, CLINDAMYCIN HYDROCHLORIDE CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE, BENZOYL PEROXIDE CLONAZEPAM, CLONAZEPAM CLOPIDOGREL BISULFATE, CLOPIDOGREL BISULFATE CYCLOBENZAPRINE HYDROCHLORIDE, CYCLOBENZAPRINE HYDROCHLORIDE DESLORATADINE, DESLORATADINE DEXMETHYLPHENIDATE HYDROCHLORIDE, DEXMETHYLPHENIDATE HYDROCHLORIDE DICLOFENAC SODIUM, DICLOFENAC SODIUM DIDANOSINE, DIDANOSINE DONEPEZIL HYDROCHLORIDE, DONEPEZIL HYDROCHLORIDE DOXEPIN HYDROCHLORIDE, DOXEPIN HYDROCHLORIDE DOXYCYCLINE HYCLATE, DOXYCYCLINE HYCLATE DOXYCYCLINE, DOXYCYCLINE ENTACAPONE, ENTACAPONE EPROSARTAN MESYLATE, EPROSARTAN MESYLATE ESZOPICLONE, ESZOPICLONE FENOFIBRATE (MICRONIZED), FENOFIBRATE FENOFIBRATE, FENOFIBRATE FENOFIBRIC ACID, CHOLINE FENOFIBRATE FENOPROFEN CALCIUM, FENOPROFEN CALCIUM FINASTERIDE, FINASTERIDE FLUOXETINE HYDROCHLORIDE, FLUOXETINE HYDROCHLORIDE FLURAZEPAM HYDROCHLORIDE, FLURAZEPAM HYDROCHLORIDE GABAPENTIN, GABAPENTIN HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE IBANDRONATE SODIUM, IBANDRONATE SODIUM IMIPRAMINE PAMOATE, IMIPRAMINE PAMOATE INDAPAMIDE, INDAPAMIDE IRBESARTAN AND HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE IRBESARTAN, IRBESARTAN ITRACONAZOLE, ITRACONAZOLE LANSOPRAZOLE, LANSOPRAZOLE LEVETIRACETAM, LEVETIRACETAM LITHIUM CARBONATE, LITHIUM CARBONATE MALATHION, MALATHION B - 76 DECEMBER 2013 - APPROVED DRUG PRODUCT LIST APPENDIX B - PRODUCT NAME SORTED BY APPLICANT ** M ** * MYLAN PHARMACEUTICALS INC MAXZIDE, HYDROCHLOROTHIAZIDE MAXZIDE-25, HYDROCHLOROTHIAZIDE MECLIZINE HYDROCHLORIDE, MECLIZINE HYDROCHLORIDE METFORMIN HYDROCHLORIDE, METFORMIN HYDROCHLORIDE METHYCLOTHIAZIDE, METHYCLOTHIAZIDE METOPROLOL SUCCINATE, METOPROLOL SUCCINATE MIDODRINE HYDROCHLORIDE, MIDODRINE HYDROCHLORIDE MINOCYCLINE HYDROCHLORIDE, MINOCYCLINE HYDROCHLORIDE MIRTAZAPINE, MIRTAZAPINE MODAFINIL, MODAFINIL MONTELUKAST SODIUM, MONTELUKAST SODIUM MORPHINE SULFATE, MORPHINE SULFATE MYCOPHENOLIC ACID, MYCOPHENOLIC ACID NABUMETONE, NABUMETONE NAPROXEN, NAPROXEN NARATRIPTAN, NARATRIPTAN HYDROCHLORIDE NEVIRAPINE, NEVIRAPINE PANTOPRAZOLE SODIUM, PANTOPRAZOLE SODIUM PAROXETINE HYDROCHLORIDE, PAROXETINE HYDROCHLORIDE PHENYTOIN, PHENYTOIN PINDOLOL, PINDOLOL PIOGLITAZONE HYDROCHLORIDE, PIOGLITAZONE HYDROCHLORIDE PRAVASTATIN SODIUM, PRAVASTATIN SODIUM PREDNISOLONE SODIUM PHOSPHATE, PREDNISOLONE SODIUM PHOSPHATE QUETIAPINE FUMARATE, QUETIAPINE FUMARATE QUININE SULFATE, QUININE SULFATE RABEPRAZOLE SODIUM, RABEPRAZOLE SODIUM RAMIPRIL, RAMIPRIL REPAGLINIDE, REPAGLINIDE RILUZOLE, RILUZOLE RISPERIDONE, RISPERIDONE RIZATRIPTAN BENZOATE, RIZATRIPTAN BENZOATE ROPINIROLE HYDROCHLORIDE, ROPINIROLE HYDROCHLORIDE SERTRALINE HYDROCHLORIDE, SERTRALINE HYDROCHLORIDE SILDENAFIL CITRATE, SILDENAFIL CITRATE SIMVASTATIN, SIMVASTATIN TIZANIDINE HYDROCHLORIDE, TIZANIDINE HYDROCHLORIDE TOLAZAMIDE, TOLAZAMIDE TOLBUTAMIDE, TOLBUTAMIDE TOLTERODINE TARTRATE, TOLTERODINE TARTRATE TRAMADOL HYDROCHLORIDE, TRAMADOL HYDROCHLORIDE TRAZODONE HYDROCHLORIDE, TRAZODONE HYDROCHLORIDE TRIAZOLAM, TRIAZOLAM VALACYCLOVIR HYDROCHLORIDE, VALACYCLOVIR HYDROCHLORIDE VALSARTAN AND HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE VORICONAZOLE, VORICONAZOLE ZIDOVUDINE, ZIDOVUDINE ZIPRASIDONE HYDROCHLORIDE, ZIPRASIDONE HYDROCHLORIDE ZOLMITRIPTAN, ZOLMITRIPTAN ZONISAMIDE, ZONISAMIDE * MYLAN PHARMACEUTICALS INC. FLUVASTATIN SODIUM, FLUVASTATIN SODIUM NIZATIDINE, NIZATIDINE OXYBUTYNIN CHLORIDE, OXYBUTYNIN CHLORIDE MYLAN SPECLT * MYLAN SPECIALTY LP ALBUTEROL SULFATE, ALBUTEROL SULFATE EPIPEN JR., EPINEPHRINE EPIPEN, EPINEPHRINE LEVALBUTEROL HYDROCHLORIDE, LEVALBUTEROL HYDROCHLORIDE PERFOROMIST, FORMOTEROL FUMARATE MYLAN TECHNOLOGIES * MYLAN TECHNOLOGIES INC CLONIDINE, CLONIDINE B - 77 DECEMBER 2013 - APPROVED DRUG PRODUCT LIST APPENDIX B - PRODUCT NAME SORTED BY APPLICANT ** M ** ** N ** * 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 LIMITED CHLOROQUINE PHOSPHATE, CHLOROQUINE PHOSPHATE * NATCO PHARMA LTD ANASTROZOLE, ANASTROZOLE CHLOROQUINE PHOSPHATE, CHLOROQUINE PHOSPHATE LANSOPRAZOLE, LANSOPRAZOLE LETROZOLE, LETROZOLE ONDANSETRON HYDROCHLORIDE, ONDANSETRON HYDROCHLORIDE RIZATRIPTAN BENZOATE, RIZATRIPTAN BENZOATE TRIHEXYPHENIDYL HYDROCHLORIDE, TRIHEXYPHENIDYL HYDROCHLORIDE NAUTILUS NEUROSCIENC * NAUTILUS NEUROSCIENCES INC CAMBIA, DICLOFENAC POTASSIUM NAVIDEA BIOPHARMS * NAVIDEA BIOPHARMACEUTICALS INC LYMPHOSEEK KIT, TECHNETIUM TC-99M TILMANOCEPT NAVINTA LLC * NAVINTA LLC BENZTROPINE MESYLATE, BENZTROPINE MESYLATE FAMOTIDINE, FAMOTIDINE FOMEPIZOLE, FOMEPIZOLE HYDRALAZINE HYDROCHLORIDE, HYDRALAZINE HYDROCHLORIDE 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 NESHER PHARMS * NESHER PHARMACEUTICALS USA LLC DILTIAZEM HYDROCHLORIDE, DILTIAZEM HYDROCHLORIDE ISOSORBIDE MONONITRATE, ISOSORBIDE MONONITRATE MICRO-K 10, POTASSIUM CHLORIDE MICRO-K, POTASSIUM CHLORIDE MORPHINE SULFATE, MORPHINE SULFATE OXYCODONE HYDROCHLORIDE, OXYCODONE HYDROCHLORIDE NEXGEN PHARMA * NEXGEN PHARMA INC BUTALBITAL AND ACETAMINOPHEN, ACETAMINOPHEN BUTALBITAL, ACETAMINOPHEN AND CAFFEINE, ACETAMINOPHEN CHENODIOL, CHENODIOL GLYCOPYRROLATE, GLYCOPYRROLATE MECAMYLAMINE HYDROCHLORIDE, MECAMYLAMINE HYDROCHLORIDE 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 B - 78 DECEMBER 2013 - APPROVED DRUG PRODUCT LIST APPENDIX B - PRODUCT NAME SORTED BY APPLICANT ** N ** NEXTWAVE PHARMS * NEXTWAVE PHARMACEUTICALS INC QUILLIVANT XR, METHYLPHENIDATE HYDROCHLORIDE NEXUS PHARMS * NEXUS PHARMACEUTICALS INC CIPROFLOXACIN HYDROCHLORIDE, CIPROFLOXACIN HYDROCHLORIDE DICLOFENAC SODIUM, DICLOFENAC SODIUM LEVOFLOXACIN, LEVOFLOXACIN NIAGARA PHARMS * NIAGARA PHARMACEUTICALS INC PUR-WASH, PURIFIED WATER (OTC) NORTHSTAR HLTHCARE * NORTHSTAR HEALTHCARE HOLDINGS LTD ALLOPURINOL, ALLOPURINOL ATENOLOL, ATENOLOL BACLOFEN, BACLOFEN GEMFIBROZIL, GEMFIBROZIL HYDROXYZINE HYDROCHLORIDE, HYDROXYZINE HYDROCHLORIDE METOCLOPRAMIDE HYDROCHLORIDE, METOCLOPRAMIDE HYDROCHLORIDE PROPRANOLOL HYDROCHLORIDE, PROPRANOLOL HYDROCHLORIDE TRAMADOL HYDROCHLORIDE, TRAMADOL HYDROCHLORIDE NOSTRUM * NOSTRUM PHARMACEUTICALS INC CARBAMAZEPINE, CARBAMAZEPINE THEOPHYLLINE, THEOPHYLLINE NOSTRUM LABS * NOSTRUM LABORATORIES INC PIROXICAM, PIROXICAM SUCRALFATE, SUCRALFATE NOSTRUM PHARMS LLC * NOSTRUM PHARMACEUTICALS LLC METFORMIN HYDROCHLORIDE, METFORMIN HYDROCHLORIDE NOVADEL * NOVADEL PHARMA INC ZOLPIMIST, ZOLPIDEM TARTRATE NOVARTIS * NOVARTIS CONSUMER HEALTH INC EXCEDRIN (MIGRAINE), ACETAMINOPHEN (OTC) HABITROL, NICOTINE (OTC) LAMISIL AT, TERBINAFINE (OTC) LAMISIL AT, TERBINAFINE HYDROCHLORIDE (OTC) NEXCEDE, KETOPROFEN (OTC) PREVACID 24 HR, LANSOPRAZOLE (OTC) TAVIST ALLERGY/SINUS/HEADACHE, ACETAMINOPHEN (OTC) THRIVE, NICOTINE POLACRILEX (OTC) VAGISTAT-1, TIOCONAZOLE (OTC) VOLTAREN, DICLOFENAC SODIUM * NOVARTIS PHARMACEUTICALS CORP AFINITOR, EVEROLIMUS AMTURNIDE, ALISKIREN HEMIFUMARATE ARCAPTA NEOHALER, INDACATEROL MALEATE CLOZARIL, CLOZAPINE COARTEM, ARTEMETHER COMBIPATCH, ESTRADIOL DESFERAL, DEFEROXAMINE MESYLATE DIOVAN HCT, HYDROCHLOROTHIAZIDE DIOVAN, VALSARTAN ESTRADERM, ESTRADIOL EXELON, RIVASTIGMINE EXELON, RIVASTIGMINE TARTRATE EXFORGE HCT, AMLODIPINE BESYLATE EXFORGE, AMLODIPINE BESYLATE EXJADE, DEFERASIROX FAMVIR, FAMCICLOVIR FANAPT, ILOPERIDONE B - 79 DECEMBER 2013 - APPROVED DRUG PRODUCT LIST APPENDIX B - PRODUCT NAME SORTED BY APPLICANT ** N ** * NOVARTIS PHARMACEUTICALS CORP FOCALIN XR, DEXMETHYLPHENIDATE HYDROCHLORIDE FOCALIN, DEXMETHYLPHENIDATE HYDROCHLORIDE FORADIL, FORMOTEROL FUMARATE GILENYA, FINGOLIMOD GLEEVEC, IMATINIB MESYLATE LAMISIL, TERBINAFINE HYDROCHLORIDE LAMPRENE, CLOFAZIMINE LESCOL XL, FLUVASTATIN SODIUM LESCOL, FLUVASTATIN SODIUM LOTREL, AMLODIPINE BESYLATE MIACALCIN, CALCITONIN SALMON MYFORTIC, MYCOPHENOLIC ACID NEORAL, CYCLOSPORINE RECLAST, ZOLEDRONIC ACID RITALIN LA, METHYLPHENIDATE HYDROCHLORIDE SANDIMMUNE, CYCLOSPORINE SANDOSTATIN LAR, OCTREOTIDE ACETATE SANDOSTATIN, OCTREOTIDE ACETATE SIGNIFOR, PASIREOTIDE DIASPARTATE STARLIX, NATEGLINIDE TASIGNA, NILOTINIB HYDROCHLORIDE MONOHYDRATE TEGRETOL-XR, CARBAMAZEPINE TEKAMLO, ALISKIREN HEMIFUMARATE TEKTURNA HCT, ALISKIREN HEMIFUMARATE TEKTURNA, ALISKIREN HEMIFUMARATE TOBI PODHALER, TOBRAMYCIN TRILEPTAL, OXCARBAZEPINE TYZEKA, TELBIVUDINE VASOCIDIN, PREDNISOLONE SODIUM PHOSPHATE VIVELLE, ESTRADIOL VIVELLE-DOT, ESTRADIOL VOLTAREN, DICLOFENAC SODIUM ZOMETA, ZOLEDRONIC ACID ZORTRESS, EVEROLIMUS NOVARTIS PHARM * NOVARTIS PHARMACEUTICAL CORP AFINITOR DISPERZ, EVEROLIMUS NOVARTIS PHARMS * NOVARTIS PHARMACEUTICALS CORP FEMARA, LETROZOLE TOBI, TOBRAMYCIN NOVAST LABS * NOVAST LABORATORIES CHINA LTD NORETHINDRONE, NORETHINDRONE NOVAST LABS LTD * NOVAST LABORATORIES LTD DASETTA 1/35, ETHINYL ESTRADIOL DASETTA 7/7/7, ETHINYL ESTRADIOL DESOGESTREL AND ETHINYL ESTRADIOL, DESOGESTREL ELINEST, ETHINYL ESTRADIOL FALMINA, ETHINYL ESTRADIOL LARIN 1/20, ETHINYL ESTRADIOL LARIN FE 1.5/30, ETHINYL ESTRADIOL LARIN FE 1/20, ETHINYL ESTRADIOL LEVONEST, ETHINYL ESTRADIOL MONO-LINYAH, ETHINYL ESTRADIOL NORETHINDRONE, NORETHINDRONE PHILITH, ETHINYL ESTRADIOL PIMTREA, DESOGESTREL TRI-LINYAH, ETHINYL ESTRADIOL WERA, ETHINYL ESTRADIOL NOVEL LABS INC * NOVEL LABORATORIES INC FAMOTIDINE, FAMOTIDINE B - 80 DECEMBER 2013 - APPROVED DRUG PRODUCT LIST APPENDIX B - B - 81 PRODUCT NAME SORTED BY APPLICANT ** N ** * NOVEL LABORATORIES INC HOMATROPINE METHYLBROMIDE AND HYDROCODONE BITARTRATE, HOMATROPINE METHYLBROMIDE LEVONORGESTREL, LEVONORGESTREL LEVONORGESTREL, LEVONORGESTREL (OTC) METHYLERGONOVINE MALEATE, METHYLERGONOVINE MALEATE MISOPROSTOL, MISOPROSTOL PEG 3350 AND ELECTROLYTES, POLYETHYLENE GLYCOL 3350 PEG-3350;POTASSIUM CHLORIDE;SODIUM BICARBONATE;SODIUM CHLORIDE, POLYETHYLENE GLYCOL PHENELZINE SULFATE, PHENELZINE SULFATE POLYETHYLENE GLYCOL 3350, POLYETHYLENE GLYCOL 3350 (OTC) TEMAZEPAM, TEMAZEPAM TINIDAZOLE, TINIDAZOLE TRIMETHOPRIM, TRIMETHOPRIM NOVEN * NOVEN PHARMACEUTICALS INC FENTANYL-100, FENTANYL FENTANYL-25, FENTANYL FENTANYL-50, FENTANYL FENTANYL-75, FENTANYL MINIVELLE, ESTRADIOL NOVEN PHARMS INC * NOVEN PHARMACEUTICALS INC DAYTRANA, METHYLPHENIDATE NOVEN THERAP * NOVEN THERAPEUTICS LLC BRISDELLE, PAROXETINE MESYLATE LITHOBID, LITHIUM CARBONATE PEXEVA, PAROXETINE MESYLATE NOVEX * NOVEX PHARMA BUTORPHANOL TARTRATE, BUTORPHANOL TARTRATE NOVO NORDISK INC * NOVO NORDISK INC ACTIVELLA, ESTRADIOL LEVEMIR FLEXPEN, INSULIN DETEMIR RECOMBINANT LEVEMIR, INSULIN DETEMIR RECOMBINANT NORDITROPIN FLEXPRO, SOMATROPIN RECOMBINANT NORDITROPIN NORDIFLEX, SOMATROPIN RECOMBINANT NOVOLIN N, INSULIN SUSP ISOPHANE RECOMBINANT HUMAN (OTC) NOVOLOG FLEXPEN, INSULIN ASPART RECOMBINANT NOVOLOG MIX 70/30 FLEXPEN, INSULIN ASPART PROTAMINE RECOMBINANT NOVOLOG MIX 70/30, INSULIN ASPART PROTAMINE RECOMBINANT NOVOLOG PENFILL, INSULIN ASPART RECOMBINANT NOVOLOG, INSULIN ASPART RECOMBINANT PRANDIMET, METFORMIN HYDROCHLORIDE PRANDIN, REPAGLINIDE VAGIFEM, ESTRADIOL VICTOZA, LIRAGLUTIDE RECOMBINANT NOVOCOL * NOVOCOL PHARMACEUTICAL INC ISOCAINE HYDROCHLORIDE, MEPIVACAINE HYDROCHLORIDE NOVOCOL INC * NOVOCOL INC LIDOCAINE, LIDOCAINE NPS PHARMS INC * NPS PHARMACEUTICALS INC GATTEX KIT, TEDUGLUTIDE RECOMBINANT NU PHARM * NU PHARM INC DIVALPROEX SODIUM, DIVALPROEX SODIUM NUPATHE * NUPATHE INC ZECUITY, SUMATRIPTAN SUCCINATE NYCOMED US DECEMBER 2013 - 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83 DECEMBER 2013 - APPROVED DRUG PRODUCT LIST APPENDIX B - PRODUCT NAME SORTED BY APPLICANT ** O ** * OSMOTICA PHARMACEUTICAL CORP NIFEDIPINE, NIFEDIPINE OXYBUTYNIN CHLORIDE, OXYBUTYNIN CHLORIDE VENLAFAXINE HYDROCHLORIDE, VENLAFAXINE HYDROCHLORIDE OSMOTICA PHARM CORP * OSMOTICA PHARMACEUTICAL CORP KHEDEZLA, DESVENLAFAXINE 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 OTSUKA PHARM CO LTD * OTSUKA PHARMACEUTICAL CO LTD ABILIFY MAINTENA KIT, ARIPIPRAZOLE OUTLOOK PHARMS * OUTLOOK PHARMACEUTICALS INC DEXTROAMPHETAMINE SULFATE, DEXTROAMPHETAMINE SULFATE ** P ** PACIRA PHARMS INC * PACIRA PHARMACEUTICALS INC DEPOCYT, CYTARABINE EXPAREL, BUPIVACAINE PACK PHARMS LLC * PACK PHARMACEUTICALS LLC CROMOLYN SODIUM, CROMOLYN SODIUM PADDOCK * PADDOCK LABORATORIES INC BENZPHETAMINE HYDROCHLORIDE, BENZPHETAMINE HYDROCHLORIDE PADDOCK LABS * PADDOCK LABORATORIES INC CLINDAMYCIN PALMITATE HYDROCHLORIDE, CLINDAMYCIN PALMITATE HYDROCHLORIDE PADDOCK LLC * PADDOCK LABORATORIES LLC CALCIUM ACETATE, CALCIUM ACETATE FLAVOXATE HYDROCHLORIDE, FLAVOXATE HYDROCHLORIDE MORPHINE SULFATE, MORPHINE SULFATE REPAGLINIDE, REPAGLINIDE TROSPIUM CHLORIDE, TROSPIUM CHLORIDE PAI * PHARMACEUTICAL ASSOCIATES INC HYDROCODONE BITARTRATE AND ACETAMINOPHEN, ACETAMINOPHEN PALADIN LABS * PALADIN LABS USA INC ANTIZOL, FOMEPIZOLE PANACEA BIOTEC LTD * PANACEA BIOTEC LTD TACROLIMUS, TACROLIMUS PAR FORM * PAR FORMULATIONS PRIVATE LTD LABETALOL HYDROCHLORIDE, LABETALOL HYDROCHLORIDE MAFENIDE ACETATE, MAFENIDE ACETATE PAR PHARM B - 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85 DECEMBER 2013 - APPROVED DRUG PRODUCT LIST APPENDIX B - PRODUCT NAME SORTED BY APPLICANT ** P ** * PARKE DAVIS DIV WARNER LAMBERT CO NEURONTIN, GABAPENTIN ZARONTIN, ETHOSUXIMIDE * PARKE DAVIS PHARMACEUTICAL RESEARCH DIV WARNER LAMBERT CO ZARONTIN, ETHOSUXIMIDE PEDIATRX * PEDIATRX INC GRANISETRON HYDROCHLORIDE, GRANISETRON HYDROCHLORIDE PEDINOL * PEDINOL PHARMACAL INC GRIS-PEG, GRISEOFULVIN, ULTRAMICROSIZE PERNIX THERAP * PERNIX THERAPEUTICS LLC CEDAX, CEFTIBUTEN DIHYDRATE PERNIX THERAPS LLC * PERNIX THERAPEUTICS LLC SILENOR, DOXEPIN HYDROCHLORIDE PERRIGO * PERRIGO CO BETAMETHASONE VALERATE, BETAMETHASONE VALERATE CICLOPIROX, CICLOPIROX CLINDETS, CLINDAMYCIN PHOSPHATE CLOBETASOL PROPIONATE, CLOBETASOL PROPIONATE ERYTHROMYCIN, ERYTHROMYCIN FAMOTIDINE, FAMOTIDINE FAMOTIDINE, FAMOTIDINE (OTC) HALOBETASOL PROPIONATE, HALOBETASOL PROPIONATE MOMETASONE FUROATE, MOMETASONE FUROATE NICOTINE POLACRILEX, NICOTINE POLACRILEX (OTC) STIE-CORT, HYDROCORTISONE PERRIGO CO TENNESSEE * PERRIGO CO TENNESSEE INC BACITRACIN ZINC AND POLYMYXIN B SULFATE, BACITRACIN ZINC BACITRACIN, BACITRACIN BACITRACIN-NEOMYCIN-POLYMYXIN W/ HYDROCORTISONE ACETATE, BACITRACIN ERYTHROMYCIN, ERYTHROMYCIN GENTAMICIN SULFATE, GENTAMICIN SULFATE GRISEOFULVIN, GRISEOFULVIN, MICROSIZE NEOMYCIN AND POLYMYXIN B SULFATES AND BACITRACIN ZINC, BACITRACIN ZINC NEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONE, DEXAMETHASONE SULFACETAMIDE SODIUM, SULFACETAMIDE SODIUM PERRIGO ISRAEL * PERRIGO ISRAEL PHARMACEUTICALS FLUOCINONIDE, FLUOCINONIDE * PERRIGO ISRAEL PHARMACEUTICALS LTD BUTOCONAZOLE NITRATE, BUTOCONAZOLE NITRATE CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE, BENZOYL PEROXIDE CLOBETASOL PROPIONATE, CLOBETASOL PROPIONATE FLUOCINOLONE ACETONIDE, FLUOCINOLONE ACETONIDE FLUTICASONE PROPIONATE, FLUTICASONE PROPIONATE HALOBETASOL PROPIONATE, HALOBETASOL PROPIONATE IMIQUIMOD, IMIQUIMOD KETOCONAZOLE, KETOCONAZOLE MESALAMINE, MESALAMINE MINOXIDIL, MINOXIDIL (OTC) NITROGLYCERIN, NITROGLYCERIN TESTOSTERONE, TESTOSTERONE PERRIGO NEW YORK * PERRIGO NEW YORK INC ACETAMINOPHEN, ACETAMINOPHEN (OTC) CENTANY, MUPIROCIN CICLOPIROX, CICLOPIROX CLINDAMYCIN PHOSPHATE, CLINDAMYCIN PHOSPHATE DESONIDE, DESONIDE GENTAMICIN SULFATE, GENTAMICIN SULFATE B - 86 DECEMBER 2013 - APPROVED DRUG PRODUCT LIST APPENDIX B - PRODUCT NAME SORTED BY APPLICANT ** P ** * PERRIGO NEW YORK INC TERCONAZOLE, TERCONAZOLE 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) CETIRIZINE HYDROCHLORIDE, CETIRIZINE HYDROCHLORIDE CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY, CETIRIZINE HYDROCHLORIDE (OTC) CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF, CETIRIZINE HYDROCHLORIDE (OTC) DESLORATADINE, DESLORATADINE GUAIFENESIN, GUAIFENESIN (OTC) IBUPROFEN AND DIPHENHYDRAMINE CITRATE, DIPHENHYDRAMINE CITRATE (OTC) IBUPROFEN, IBUPROFEN IBUPROFEN, IBUPROFEN (OTC) LANSOPRAZOLE, LANSOPRAZOLE (OTC) LEVONORGESTREL, LEVONORGESTREL LEVONORGESTREL, LEVONORGESTREL (OTC) LOPERAMIDE HYDROCHLORIDE, LOPERAMIDE HYDROCHLORIDE (OTC) MICONAZOLE NITRATE, MICONAZOLE NITRATE (OTC) NAPROXEN, NAPROXEN NICOTINE POLACRILEX, NICOTINE POLACRILEX (OTC) POLYETHYLENE GLYCOL 3350, POLYETHYLENE GLYCOL 3350 (OTC) RANITIDINE HYDROCHLORIDE, RANITIDINE HYDROCHLORIDE (OTC) PERRIGO UK FINCO * PERRIGO UK FINCO LTD PARTNERSHIP CLINDAMYCIN PHOSPHATE, CLINDAMYCIN PHOSPHATE PETNET * PETNET SOLUTIONS INC FLUDEOXYGLUCOSE F18, FLUDEOXYGLUCOSE F-18 PF PRISM * PF PRISM CV LYRICA, PREGABALIN PF PRISM CV * PF PRISM CV RAPAMUNE, SIROLIMUS TORISEL, TEMSIROLIMUS TYGACIL, TIGECYCLINE XALKORI, CRIZOTINIB XELJANZ, TOFACITINIB CITRATE ZMAX, AZITHROMYCIN PFIZER * PFIZER CENTRAL RESEARCH DIFLUCAN, FLUCONAZOLE ZITHROMAX, AZITHROMYCIN * PFIZER CHEMICALS DIV PFIZER INC DIFLUCAN, FLUCONAZOLE ZITHROMAX, AZITHROMYCIN * PFIZER INC ACOVA, ARGATROBAN ADVIL LIQUI-GELS, IBUPROFEN (OTC) ADVIL MIGRAINE LIQUI-GELS, IBUPROFEN (OTC) ALAVERT, LORATADINE (OTC) AXID AR, NIZATIDINE (OTC) CADUET, AMLODIPINE BESYLATE CALAN SR, VERAPAMIL HYDROCHLORIDE CARDURA XL, DOXAZOSIN MESYLATE CHILDREN'S ADVIL, IBUPROFEN (OTC) CHILDREN'S ADVIL-FLAVORED, IBUPROFEN (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 ELELYSO, TALIGLUCERASE ALFA FLAGYL I.V. RTU IN PLASTIC CONTAINER, METRONIDAZOLE GEODON, ZIPRASIDONE HYDROCHLORIDE B - 87 DECEMBER 2013 - APPROVED DRUG PRODUCT LIST APPENDIX B - PRODUCT NAME SORTED BY APPLICANT ** P ** * PFIZER INC GEODON, ZIPRASIDONE MESYLATE GLUCOTROL XL, GLIPIZIDE HEPARIN SODIUM PRESERVATIVE FREE, HEPARIN SODIUM HEPARIN SODIUM, HEPARIN SODIUM INLYTA, AXITINIB JUNIOR STRENGTH ADVIL, IBUPROFEN (OTC) LIPITOR, ATORVASTATIN CALCIUM LORATADINE, LORATADINE (OTC) NAVANE, THIOTHIXENE NORVASC, AMLODIPINE BESYLATE PEDIATRIC ADVIL, IBUPROFEN (OTC) PROCARDIA, NIFEDIPINE REVATIO, SILDENAFIL CITRATE SONATA, ZALEPLON TOVIAZ, FESOTERODINE FUMARATE UNASYN, AMPICILLIN SODIUM VFEND, VORICONAZOLE ZITHROMAX, AZITHROMYCIN * PFIZER LABORATORIES DIV PFIZER INC CARDURA, DOXAZOSIN MESYLATE PROCARDIA XL, NIFEDIPINE UNASYN, AMPICILLIN SODIUM VIBRAMYCIN, DOXYCYCLINE * PFIZER PHARMACEUTICALS INC ZOLOFT, SERTRALINE HYDROCHLORIDE PFIZER CONS HLTHCARE * PFIZER CONSUMER HEALTHCARE ADVIL, IBUPROFEN SODIUM (OTC) 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 NEURONTIN, GABAPENTIN NITROSTAT, NITROGLYCERIN PHARM ASSOC * PHARMACEUTICAL ASSOC INC CYPROHEPTADINE HYDROCHLORIDE, CYPROHEPTADINE HYDROCHLORIDE HYDROCODONE BITARTRATE AND ACETAMINOPHEN, ACETAMINOPHEN LORAZEPAM, LORAZEPAM PREDNISOLONE SODIUM PHOSPHATE, PREDNISOLONE SODIUM PHOSPHATE * PHARMACEUTICAL ASSOC INC DIV BEACH PRODUCTS AMANTADINE HYDROCHLORIDE, AMANTADINE HYDROCHLORIDE DIPHENHYDRAMINE HYDROCHLORIDE, DIPHENHYDRAMINE HYDROCHLORIDE ETHOSUXIMIDE, ETHOSUXIMIDE FLUOXETINE HYDROCHLORIDE, FLUOXETINE HYDROCHLORIDE FLUPHENAZINE HYDROCHLORIDE, FLUPHENAZINE HYDROCHLORIDE HYDROCODONE BITARTRATE AND ACETAMINOPHEN, ACETAMINOPHEN PREDNISOLONE, PREDNISOLONE RANITIDINE HYDROCHLORIDE, RANITIDINE HYDROCHLORIDE TRIHEXYPHENIDYL HYDROCHLORIDE, TRIHEXYPHENIDYL HYDROCHLORIDE * PHARMACEUTICAL ASSOCIATES INC ACETAMINOPHEN AND CODEINE PHOSPHATE, ACETAMINOPHEN B - 88 DECEMBER 2013 - APPROVED DRUG PRODUCT LIST APPENDIX B - PRODUCT NAME SORTED BY APPLICANT ** P ** PHARMACEUTICS * PHARMACEUTICS INTERNATIONAL INC ZOLEDRONIC ACID, ZOLEDRONIC ACID PHARMACHEMIE * PHARMACHEMIE BV CARBOPLATIN, CARBOPLATIN PHARMACHEMIE BV * PHARMACHEMIE BV METHOTREXATE PRESERVATIVE FREE, METHOTREXATE SODIUM METHOTREXATE SODIUM PRESERVATIVE FREE, METHOTREXATE SODIUM PHARMACIA AND UPJOHN * PHARMACIA AND UPJOHN XANAX XR, ALPRAZOLAM * PHARMACIA AND UPJOHN CO AROMASIN, EXEMESTANE AZULFIDINE EN-TABS, SULFASALAZINE CAVERJECT IMPULSE, ALPROSTADIL CAVERJECT, ALPROSTADIL CLEOCIN HYDROCHLORIDE, CLINDAMYCIN HYDROCHLORIDE CLEOCIN PHOSPHATE IN DEXTROSE 5% IN PLASTIC CONTAINER, 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-MEDROL, METHYLPREDNISOLONE ACETATE DEPO-PROVERA, MEDROXYPROGESTERONE ACETATE DETROL LA, TOLTERODINE TARTRATE DETROL, TOLTERODINE TARTRATE DIDREX, BENZPHETAMINE HYDROCHLORIDE FLAVORED COLESTID, COLESTIPOL HYDROCHLORIDE GENOTROPIN PRESERVATIVE FREE, SOMATROPIN RECOMBINANT GENOTROPIN, SOMATROPIN RECOMBINANT IDAMYCIN PFS, IDARUBICIN HYDROCHLORIDE LINCOCIN, LINCOMYCIN HYDROCHLORIDE MEDROL, METHYLPREDNISOLONE NICOTROL, NICOTINE SOLU-MEDROL, METHYLPREDNISOLONE SODIUM SUCCINATE SOMAVERT, PEGVISOMANT XALATAN, LATANOPROST ZINECARD, DEXRAZOXANE HYDROCHLORIDE ZYVOX, LINEZOLID * PHARMACIA AND UPJOHN SUB PFIZER INC DEPO-SUBQ PROVERA 104, MEDROXYPROGESTERONE ACETATE PHARMACYCLICS INC * PHARMACYCLICS INC IMBRUVICA, IBRUTINIB PHARMAFORCE * PHARMAFORCE INC CIPROFLOXACIN HYDROCHLORIDE, CIPROFLOXACIN HYDROCHLORIDE NANDROLONE DECANOATE, NANDROLONE DECANOATE NICARDIPINE HYDROCHLORIDE, NICARDIPINE HYDROCHLORIDE PHARMALUCENCE * PHARMALUCENCE INC TECHNETIUM TC 99M SESTAMIBI, TECHNETIUM TC-99M SESTAMIBI KIT PHARMAX * PHARMAX GROUP INC BETHANECHOL CHLORIDE, BETHANECHOL CHLORIDE PHARMAXIS LTD * PHARMAXIS LTD ARIDOL KIT, MANNITOL PHARMS B - 89 DECEMBER 2013 - APPROVED DRUG PRODUCT LIST APPENDIX B - PRODUCT NAME SORTED BY APPLICANT ** P ** * PHARMACEUTICALS INTERNATIONAL ZOLEDRONIC ACID, ZOLEDRONIC ACID PHOTOCURE ASA * PHOTOCURE ASA CYSVIEW KIT, HEXAMINOLEVULINATE HYDROCHLORIDE PIERRE FABRE * PIERRE FABRE MEDICAMENT NAVELBINE, VINORELBINE TARTRATE PIERREL * PIERREL S.P.A. 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93 DECEMBER 2013 - APPROVED DRUG PRODUCT LIST APPENDIX B - PRODUCT NAME SORTED BY APPLICANT ** R ** * RECORDATI RARE DISEASES INC PEGANONE, ETHOTOIN TRANXENE, CLORAZEPATE DIPOTASSIUM REMPEX PHARMS INC * REMPEX PHARMACEUTICALS INC MINOCIN, MINOCYCLINE HYDROCHLORIDE RENAISSANCE PHARMA * RENAISSANCE PHARMA US HOLDINGS INC ELIMITE, PERMETHRIN RHODES PHARMS * RHODES PHARMACEUTICALS LP MORPHINE SULFATE, MORPHINE SULFATE OXYCODONE HYDROCHLORIDE, OXYCODONE HYDROCHLORIDE THEOPHYLLINE, THEOPHYLLINE UNIPHYL, THEOPHYLLINE RICONPHARMA LLC * RICONPHARMA LLC GRISEOFULVIN, ULTRAMICROSIZE, GRISEOFULVIN, ULTRAMICROSIZE ROCHE PALO * ROCHE PALO ALTO LLC CELLCEPT, MYCOPHENOLATE MOFETIL CELLCEPT, MYCOPHENOLATE MOFETIL HYDROCHLORIDE CYTOVENE, GANCICLOVIR SODIUM ROCKWELL MEDCL * ROCKWELL MEDICAL TECHNOLOGIES INC CALCITRIOL, CALCITRIOL ROMARK * ROMARK LABORATORIES ALINIA, NITAZOXANIDE ROSEDALE THERAPEUTIC * ROSEDALE THERAPEUTICS ERGOMAR, ERGOTAMINE TARTRATE ROUSES POINT PHARMS * ROUSES POINT PHARMACEUTICALS LLC LEVETIRACETAM, LEVETIRACETAM ROXANE * ROXANE LABORATORIES INC ACARBOSE, ACARBOSE ALENDRONATE SODIUM, ALENDRONATE SODIUM AMLODIPINE BESYLATE, AMLODIPINE BESYLATE ANASTROZOLE, ANASTROZOLE BALSALAZIDE DISODIUM, BALSALAZIDE DISODIUM BICALUTAMIDE, BICALUTAMIDE BUPRENORPHINE HYDROCHLORIDE, BUPRENORPHINE HYDROCHLORIDE BUTORPHANOL TARTRATE, BUTORPHANOL TARTRATE CALCITRIOL, CALCITRIOL CALCIUM ACETATE, CALCIUM ACETATE CEVIMELINE HYDROCHLORIDE, CEVIMELINE HYDROCHLORIDE CILOSTAZOL, CILOSTAZOL CITALOPRAM HYDROBROMIDE, CITALOPRAM HYDROBROMIDE CLARITHROMYCIN, CLARITHROMYCIN CLOPIDOGREL BISULFATE, CLOPIDOGREL BISULFATE CLOTRIMAZOLE, CLOTRIMAZOLE CODEINE SULFATE, CODEINE SULFATE CYCLOPHOSPHAMIDE, CYCLOPHOSPHAMIDE DEXAMETHASONE, DEXAMETHASONE DIGOXIN, DIGOXIN DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE, ATROPINE SULFATE DONEPEZIL HYDROCHLORIDE, DONEPEZIL HYDROCHLORIDE DOXERCALCIFEROL, DOXERCALCIFEROL EXEMESTANE, EXEMESTANE FAMCICLOVIR, FAMCICLOVIR FLECAINIDE ACETATE, FLECAINIDE ACETATE FLUCONAZOLE, FLUCONAZOLE B - 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95 DECEMBER 2013 - APPROVED DRUG PRODUCT LIST APPENDIX B - PRODUCT NAME SORTED BY APPLICANT ** S ** * SAGENT PHARMACEUTICALS INC ATRACURIUM BESYLATE, ATRACURIUM BESYLATE CAFFEINE CITRATE, CAFFEINE CITRATE CALCITRIOL, CALCITRIOL CARBOPLATIN, CARBOPLATIN DOXORUBICIN HYDROCHLORIDE, DOXORUBICIN HYDROCHLORIDE FLUMAZENIL, FLUMAZENIL GEMCITABINE HYDROCHLORIDE, GEMCITABINE HYDROCHLORIDE HALOPERIDOL, HALOPERIDOL LACTATE HEPARIN SODIUM PRESERVATIVE FREE, HEPARIN SODIUM HEPARIN SODIUM, HEPARIN SODIUM KETOROLAC TROMETHAMINE, KETOROLAC TROMETHAMINE LEUCOVORIN CALCIUM PRESERVATIVE FREE, LEUCOVORIN CALCIUM LEVETIRACETAM, LEVETIRACETAM LEVOFLOXACIN, LEVOFLOXACIN MESNA, MESNA NAFCILLIN SODIUM, NAFCILLIN SODIUM OCTREOTIDE ACETATE (PRESERVATIVE FREE), OCTREOTIDE ACETATE OCTREOTIDE ACETATE, OCTREOTIDE ACETATE ORPHENADRINE CITRATE, ORPHENADRINE CITRATE OXACILLIN SODIUM, OXACILLIN SODIUM TOPOTECAN HYDROCHLORIDE, TOPOTECAN HYDROCHLORIDE VANCOMYCIN HYDROCHLORIDE, VANCOMYCIN HYDROCHLORIDE SAGENT STRIDES * SAGENT STRIDES LLC AZITHROMYCIN, AZITHROMYCIN BACITRACIN, BACITRACIN CLINDAMYCIN PHOSPHATE, CLINDAMYCIN PHOSPHATE GRANISETRON HYDROCHLORIDE, GRANISETRON HYDROCHLORIDE LABETALOL HYDROCLORIDE, LABETALOL HYDROCHLORIDE METOPROLOL TARTRATE, METOPROLOL TARTRATE MIDAZOLAM HYDROCHLORIDE PRESERVATIVE FREE, MIDAZOLAM HYDROCHLORIDE MIDOZALAM HYDROCHLORIDE, MIDAZOLAM HYDROCHLORIDE POLYMYCIN B SULFATE, POLYMYXIN B SULFATE ROCURONIUM BROMIDE, ROCURONIUM BROMIDE SUMATRIPTAN SUCCINATE, SUMATRIPTAN SUCCINATE SALIX PHARMS * SALIX PHARMACEUTICALS INC ANUSOL HC, HYDROCORTISONE APRISO, MESALAMINE COLAZAL, BALSALAZIDE DISODIUM DIURIL, CHLOROTHIAZIDE FULYZAQ, CROFELEMER GIAZO, BALSALAZIDE DISODIUM METOZOLV ODT, METOCLOPRAMIDE HYDROCHLORIDE MOVIPREP, ASCORBIC ACID OSMOPREP, SODIUM PHOSPHATE, DIBASIC, ANHYDROUS PEPCID, FAMOTIDINE RELISTOR, METHYLNALTREXONE BROMIDE XIFAXAN, RIFAXIMIN SALIX PHARMS INC * SALIX PHARMACEUTICALS INC FENOGLIDE, FENOFIBRATE GLUMETZA, METFORMIN HYDROCHLORIDE ZEGERID, OMEPRAZOLE SAMSON MEDCL * SAMSON MEDICAL TECHNOLOGIES LLC CEFAZOLIN SODIUM, CEFAZOLIN SODIUM SANDOZ * SANDOZ DOCETAXEL, DOCETAXEL * SANDOZ CANADA INC ANECTINE, SUCCINYLCHOLINE CHLORIDE ARISTOSPAN, TRIAMCINOLONE HEXACETONIDE BRIMONIDINE TARTRATE, BRIMONIDINE TARTRATE B - 96 DECEMBER 2013 - APPROVED DRUG PRODUCT LIST APPENDIX B - B - 97 PRODUCT NAME SORTED BY APPLICANT ** S ** * SANDOZ CANADA INC 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 TESTOSTERONE CYPIONATE, TESTOSTERONE CYPIONATE TRIAMCINOLONE ACETONIDE, TRIAMCINOLONE ACETONIDE * SANDOZ INC ALTAVERA, ETHINYL ESTRADIOL 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 ANASTROZOLE, ANASTROZOLE APREPITANT, APREPITANT ARGATROBAN IN SODIUM CHLORIDE, ARGATROBAN AZITHROMYCIN, AZITHROMYCIN BICALUTAMIDE, BICALUTAMIDE BUDESONIDE, BUDESONIDE BUMETANIDE, BUMETANIDE CAFERGOT, CAFFEINE CANDESARTAN CILEXETIL, CANDESARTAN CILEXETIL CARVEDILOL, CARVEDILOL CEFADROXIL, CEFADROXIL/CEFADROXIL HEMIHYDRATE CEFAZOLIN SODIUM, CEFAZOLIN SODIUM CEFDINIR, CEFDINIR CEFPODOXIME PROXETIL, CEFPODOXIME PROXETIL CEFPROZIL, CEFPROZIL CEFTRIAXONE, CEFTRIAXONE SODIUM CETIRIZINE HYDROCHLORIDE ALLERGY, CETIRIZINE HYDROCHLORIDE (OTC) CETIRIZINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE, CETIRIZINE HYDROCHLORIDE CHLORPROMAZINE HYDROCHLORIDE, CHLORPROMAZINE HYDROCHLORIDE CHOLESTYRAMINE LIGHT, CHOLESTYRAMINE CHOLESTYRAMINE, CHOLESTYRAMINE CILOSTAZOL, CILOSTAZOL CLARITHROMYCIN, CLARITHROMYCIN COSYNTROPIN, COSYNTROPIN DESLORATADINE, DESLORATADINE DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE, AMPHETAMINE DICLOFENAC SODIUM AND MISOPROSTOL, DICLOFENAC SODIUM DICLOFENAC SODIUM, DICLOFENAC SODIUM DICLOXACILLIN SODIUM, DICLOXACILLIN SODIUM DILTIAZEM HYDROCHLORIDE, DILTIAZEM HYDROCHLORIDE DIVALPROEX SODIUM, DIVALPROEX SODIUM DONEPEZIL HYDROCHLORIDE, DONEPEZIL HYDROCHLORIDE DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE, DORZOLAMIDE HYDROCHLORIDE ENOXAPARIN SODIUM (PRESERVATIVE FREE), ENOXAPARIN SODIUM DECEMBER 2013 - APPROVED DRUG PRODUCT LIST APPENDIX B - PRODUCT NAME SORTED BY APPLICANT ** S ** * SANDOZ INC EPLERENONE, EPLERENONE ESTARYLLA, ETHINYL ESTRADIOL FLUDARABINE PHOSPHATE, FLUDARABINE PHOSPHATE FLUOROURACIL, FLUOROURACIL FLUOXETINE HYDROCHLORIDE, FLUOXETINE HYDROCHLORIDE FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE, FOSINOPRIL SODIUM GALANTAMINE HYDROBROMIDE, GALANTAMINE HYDROBROMIDE GRISEOFULVIN, GRISEOFULVIN, MICROSIZE HALOPERIDOL, HALOPERIDOL HEPARIN SODIUM, HEPARIN SODIUM IDARUBICIN HYDROCHLORIDE, IDARUBICIN HYDROCHLORIDE INDOMETHACIN, INDOMETHACIN INTROVALE, ETHINYL ESTRADIOL IRBESARTAN AND HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE IRBESARTAN, IRBESARTAN LABETALOL HYDROCHLORIDE, LABETALOL HYDROCHLORIDE LANSOPRAZOLE, LANSOPRAZOLE LEFLUNOMIDE, LEFLUNOMIDE LEUPROLIDE ACETATE, LEUPROLIDE ACETATE LEVETIRACETAM, LEVETIRACETAM LEVOCETIRIZINE DIHYDROCHLORIDE, LEVOCETIRIZINE DIHYDROCHLORIDE LEVOFLOXACIN, LEVOFLOXACIN LORAZEPAM, LORAZEPAM LORYNA, DROSPIRENONE LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE LOSARTAN POTASSIUM, LOSARTAN POTASSIUM MEFLOQUINE HYDROCHLORIDE, MEFLOQUINE HYDROCHLORIDE MEROPENEM, MEROPENEM METAXALONE, METAXALONE METFORMIN HYDROCHLORIDE, METFORMIN HYDROCHLORIDE METHADONE HYDROCHLORIDE, METHADONE HYDROCHLORIDE MINOCYCLINE HYDROCHLORIDE, MINOCYCLINE HYDROCHLORIDE MYCOPHENOLATE MOFETIL, MYCOPHENOLATE MOFETIL NAFCILLIN SODIUM, NAFCILLIN SODIUM NARATRIPTAN, NARATRIPTAN HYDROCHLORIDE OLANZAPINE AND FLUOXETINE HYDROCHLORIDE, FLUOXETINE HYDROCHLORIDE OMEPRAZOLE, OMEPRAZOLE OMNITROPE, SOMATROPIN RECOMBINANT ONDANSETRON HYDROCHLORIDE, ONDANSETRON HYDROCHLORIDE ONDANSETRON, ONDANSETRON ORPHENADRINE CITRATE, ORPHENADRINE CITRATE OXACILLIN SODIUM, OXACILLIN SODIUM OXALIPLATIN, OXALIPLATIN PENICILLIN G SODIUM, PENICILLIN G SODIUM PENICILLIN V POTASSIUM, PENICILLIN V POTASSIUM PERPHENAZINE, PERPHENAZINE PHENTERMINE HYDROCHLORIDE, PHENTERMINE HYDROCHLORIDE PIOGLITAZONE HYDROCHLORIDE AND GLIMEPIRIDE, GLIMEPIRIDE PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE, METFORMIN HYDROCHLORIDE PIOGLITAZONE HYDROCHLORIDE, PIOGLITAZONE HYDROCHLORIDE PIPERACILLIN AND TAZOBACTAM, PIPERACILLIN SODIUM PRAMIPEXOLE DIHYDROCHLORIDE, PRAMIPEXOLE DIHYDROCHLORIDE PROCHLORPERAZINE MALEATE, PROCHLORPERAZINE MALEATE PROMETHAZINE HYDROCHLORIDE, PROMETHAZINE HYDROCHLORIDE QUETIAPINE FUMARATE, QUETIAPINE FUMARATE QUINIDINE SULFATE, QUINIDINE SULFATE RAMIPRIL, RAMIPRIL REPAGLINIDE, REPAGLINIDE RIBAVIRIN, RIBAVIRIN RISPERIDONE, RISPERIDONE RIZATRIPTAN BENZOATE, RIZATRIPTAN BENZOATE SUMATRIPTAN SUCCINATE, SUMATRIPTAN SUCCINATE SYEDA, DROSPIRENONE TACROLIMUS, TACROLIMUS B - 98 DECEMBER 2013 - APPROVED DRUG PRODUCT LIST APPENDIX B - PRODUCT NAME SORTED BY APPLICANT ** S ** * SANDOZ INC TAMSULOSIN HYDROCHLORIDE, TAMSULOSIN HYDROCHLORIDE TRI-ESTARYLLA, ETHINYL ESTRADIOL VALACYCLOVIR HYDROCHLORIDE, VALACYCLOVIR HYDROCHLORIDE VANCOMYCIN HYDROCHLORIDE, VANCOMYCIN HYDROCHLORIDE ZOLPIDEM TARTRATE, ZOLPIDEM TARTRATE ZONISAMIDE, ZONISAMIDE SANDOZ CANADA INC * SANDOZ CANADA INC PARICALCITOL, PARICALCITOL TRIAMCINOLONE ACETONIDE, TRIAMCINOLONE ACETONIDE SANDOZ INC * SANDOZ INC AMOXICILLIN AND CLAVULANATE POTASSIUM, AMOXICILLIN ATORVASTATIN CALCIUM, ATORVASTATIN CALCIUM CEFTRIAXONE, CEFTRIAXONE SODIUM CISATRACURIUM BESYLATE PRESERVATIVE FREE, CISATRACURIUM BESYLATE CISATRACURIUM BESYLATE, CISATRACURIUM BESYLATE CLINDAMYCIN PHOSPHATE IN 5% DEXTROSE IN PLASTIC CONTAINER, CLINDAMYCIN PHOSPHATE DOXORUBICIN HYDROCHLORIDE, DOXORUBICIN HYDROCHLORIDE ENOXAPARIN SODIUM, ENOXAPARIN SODIUM MONTELUKAST SODIUM, MONTELUKAST SODIUM OLANZAPINE, OLANZAPINE ROPINIROLE HYDROCHLORIDE, ROPINIROLE HYDROCHLORIDE TIZANIDINE HYDROCHLORIDE, TIZANIDINE HYDROCHLORIDE VANCOMYCIN HYDROCHLORIDE, VANCOMYCIN HYDROCHLORIDE VORICONAZOLE, VORICONAZOLE ZIPRASIDONE HYDROCHLORIDE, ZIPRASIDONE HYDROCHLORIDE SANOCHEMIA CORP USA * SANOCHEMIA CORP USA SCANLUX-300, IOPAMIDOL SCANLUX-370, IOPAMIDOL SANOFI AVENTIS US * SANOFI AVENTIS US INC JEVTANA KIT, CABAZITAXEL * SANOFI AVENTIS US LLC ALLEGRA ALLERGY, FEXOFENADINE HYDROCHLORIDE (OTC) ALLEGRA HIVES, FEXOFENADINE HYDROCHLORIDE (OTC) ALLEGRA, FEXOFENADINE HYDROCHLORIDE ALLEGRA-D 12 HOUR ALLERGY AND CONGESTION, FEXOFENADINE HYDROCHLORIDE (OTC) ALLEGRA-D 24 HOUR ALLERGY AND CONGESTION, FEXOFENADINE HYDROCHLORIDE (OTC) AMBIEN CR, ZOLPIDEM TARTRATE AMBIEN, ZOLPIDEM TARTRATE ANZEMET, DOLASETRON MESYLATE APIDRA SOLOSTAR, INSULIN GLULISINE RECOMBINANT APIDRA, INSULIN GLULISINE RECOMBINANT AUBAGIO, TERIFLUNOMIDE AUVI-Q, EPINEPHRINE AVALIDE, HYDROCHLOROTHIAZIDE AVAPRO, IRBESARTAN CHILDREN'S ALLEGRA ALLERGY, FEXOFENADINE HYDROCHLORIDE (OTC) CHILDREN'S ALLEGRA HIVES, FEXOFENADINE HYDROCHLORIDE (OTC) CLAFORAN, CEFOTAXIME SODIUM DDAVP, DESMOPRESSIN ACETATE DEMEROL, MEPERIDINE HYDROCHLORIDE DIABETA, GLYBURIDE ELOXATIN, OXALIPLATIN FERRLECIT, SODIUM FERRIC GLUCONATE COMPLEX LANTUS SOLOSTAR, INSULIN GLARGINE RECOMBINANT LOVENOX (PRESERVATIVE FREE), ENOXAPARIN SODIUM LOVENOX, ENOXAPARIN SODIUM MULTAQ, DRONEDARONE HYDROCHLORIDE NASACORT ALLERGY 24 HOUR, TRIAMCINOLONE ACETONIDE (OTC) NORPRAMIN, DESIPRAMINE HYDROCHLORIDE PLAVIX, CLOPIDOGREL BISULFATE B - 99 DECEMBER 2013 - APPROVED DRUG PRODUCT LIST APPENDIX B - PRODUCT NAME SORTED BY APPLICANT ** S ** * SANOFI AVENTIS US LLC RIFAMATE, ISONIAZID TAXOTERE, DOCETAXEL SANOFI PASTEUR INC * SANOFI PASTEUR INC SKLICE, IVERMECTIN SANTARUS * SANTARUS INC UCERIS, BUDESONIDE SANTEN * SANTEN INC IQUIX, LEVOFLOXACIN QUIXIN, LEVOFLOXACIN SANTOS BIOTECH * SANTOS BIOTECH INDUSTRIES INC ANASTROZOLE, ANASTROZOLE 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 CORP ASMANEX TWISTHALER, MOMETASONE FUROATE INTEGRILIN, EPTIFIBATIDE NOXAFIL, POSACONAZOLE REBETOL, RIBAVIRIN SCHERING CORP * SCHERING CORP LOTRISONE, BETAMETHASONE DIPROPIONATE SCHERING PLOUGH * SCHERING PLOUGH HEALTHCARE PRODUCTS INC CHILDREN'S CLARITIN, LORATADINE (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) LOTRIMIN ULTRA, BUTENAFINE HYDROCHLORIDE (OTC) MIRALAX, POLYETHYLENE GLYCOL 3350 (OTC) NASONEX, MOMETASONE FUROATE MONOHYDRATE SHADE UVAGUARD, AVOBENZONE (OTC) SCIECURE PHARMA INC * SCIECURE PHARMA INC DORAL, QUAZEPAM SCIEGEN PHARMS INC * SCIEGEN PHARMACEUTICALS INC METFORMIN HYDROCHLORIDE, METFORMIN HYDROCHLORIDE NEVIRAPINE, NEVIRAPINE SCIOS LLC * SCIOS LLC NATRECOR, NESIRITIDE RECOMBINANT SEBELA IRELAND LTD * SEBELA IRELAND LTD MICORT-HC, HYDROCORTISONE ACETATE PRAMOSONE, HYDROCORTISONE ACETATE SECAN PHARMS * SECAN PHARMACEUTICALS INC AMLODIPINE BESYLATE, AMLODIPINE BESYLATE B - 100 DECEMBER 2013 - APPROVED DRUG PRODUCT LIST APPENDIX B - PRODUCT NAME SORTED BY APPLICANT ** S ** SEPTODONT * SEPTODONT INC BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE, BUPIVACAINE HYDROCHLORIDE OCTOCAINE, EPINEPHRINE SEPTODONT HOLDING * SEPTODONT HOLDING SAS ORAVERSE, PHENTOLAMINE MESYLATE SEPTODONT INC * SEPTODONT INC PRILOCAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE, EPINEPHRINE BITARTRATE PRILOCAINE HYDROCHLORIDE, PRILOCAINE HYDROCHLORIDE SETON PHARM * SETON PHARMACEUTICAL LLC PEDIAPRED, PREDNISOLONE SODIUM PHOSPHATE SHASUN CHEMS * SHASUN CHEMICALS AND DRUGS LTD RANITIDINE HYDROCHLORIDE, RANITIDINE HYDROCHLORIDE (OTC) SHASUN USA * SHASUN USA INC IBUPROFEN, IBUPROFEN SHIONOGI INC * SHIONOGI INC DORIBAX, DORIPENEM KEFLEX, CEPHALEXIN MOXATAG, AMOXICILLIN OSPHENA, OSPEMIFENE 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 CARBATROL, CARBAMAZEPINE INTUNIV, GUANFACINE HYDROCHLORIDE LIALDA, MESALAMINE SHIRE DEVELOPMENT * SHIRE DEVELOPMENT INC VYVANSE, LISDEXAMFETAMINE DIMESYLATE SHIRE HUMAN GENETIC * SHIRE HUMAN GENETIC THERAPIES INC VPRIV, VELAGLUCERASE ALFA SHIRE LLC * SHIRE DEVELOPMENT LLC AGRYLIN, ANAGRELIDE HYDROCHLORIDE FOSRENOL, LANTHANUM CARBONATE SALURON, HYDROFLUMETHIAZIDE SHIRE ORPHAN THERAP * SHIRE ORPHAN THERAPIES INC FIRAZYR, ICATIBANT ACETATE SIGMA TAU * SIGMA TAU PHARMACEUTICALS INC ABELCET, AMPHOTERICIN B ADAGEN, PEGADEMASE BOVINE CARNITOR SF, LEVOCARNITINE CARNITOR, LEVOCARNITINE CYSTARAN, CYSTEAMINE HYDROCHLORIDE SIGMAPHARM LABS LLC * SIGMAPHARM LABORATORIES LLC ADEFOVIR DIPIVOXIL, ADEFOVIR DIPIVOXIL AMILORIDE HYDROCHLORIDE, AMILORIDE HYDROCHLORIDE DISULFIRAM, DISULFIRAM ERGOCALCIFEROL, ERGOCALCIFEROL B - 101 DECEMBER 2013 - APPROVED DRUG PRODUCT LIST APPENDIX B - PRODUCT NAME SORTED BY APPLICANT ** S ** * SIGMAPHARM LABORATORIES LLC FLUCYTOSINE, FLUCYTOSINE GRISEOFULVIN, GRISEOFULVIN, MICROSIZE GRISEOFULVIN,ULTRAMICROSIZE, GRISEOFULVIN, ULTRAMICROSIZE LIOTHYRONINE SODIUM, LIOTHYRONINE SODIUM PROTRIPTYLINE HYDROCHLORIDE, PROTRIPTYLINE HYDROCHLORIDE SODIUM PHENYLBUTYRATE, SODIUM PHENYLBUTYRATE SILARX * SILARX PHARMACEUTICALS INC AMANTADINE HYDROCHLORIDE, AMANTADINE HYDROCHLORIDE CETIRIZINE HYDROCHLORIDE, CETIRIZINE HYDROCHLORIDE CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY, CETIRIZINE HYDROCHLORIDE (OTC) CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF, CETIRIZINE HYDROCHLORIDE (OTC) CITALOPRAM HYDROBROMIDE, CITALOPRAM HYDROBROMIDE FLUOXETINE HYDROCHLORIDE, FLUOXETINE HYDROCHLORIDE LEVETIRACETAM, LEVETIRACETAM LORATADINE, LORATADINE (OTC) METAPROTERENOL SULFATE, METAPROTERENOL SULFATE ONDANSETRON HYDROCHLORIDE, ONDANSETRON HYDROCHLORIDE RANITIDINE HYDROCHLORIDE, RANITIDINE HYDROCHLORIDE THEOPHYLLINE, THEOPHYLLINE SILARX PHARMS INC * SILARX PHARMACEUTICALS INC ESCITALOPRAM OXALATE, ESCITALOPRAM OXALATE HYDROXYZINE HYDROCHLORIDE, HYDROXYZINE HYDROCHLORIDE SILVERGATE PHARMS * SILVERGATE PHARMACEUTICALS INC EPANED KIT, ENALAPRIL MALEATE SKINMEDICA * SKINMEDICA INC VANIQA, EFLORNITHINE HYDROCHLORIDE SKYEPHARMA AG * SKYEPHARMA AG TRIGLIDE, FENOFIBRATE SMITHKLINE BEECHAM * SMITHKLINE BEECHAM LOVAZA, OMEGA-3-ACID ETHYL ESTERS * SMITHKLINE BEECHAM CORP DBA GLAXOSMITHKLINE ARRANON, NELARABINE COREG, CARVEDILOL TREXIMET, NAPROXEN SODIUM TYKERB, LAPATINIB DITOSYLATE SOFGEN PHARMS * SOFGEN PHARMACEUTICALS LLC PROGESTERONE, PROGESTERONE SOMERSET * SOMERSET PHARMACEUTICALS INC EMSAM, SELEGILINE SPEAR PHARMS * SPEAR PHARMACEUTICALS INC FLUOROURACIL, FLUOROURACIL SPEAR PHARMS INC * SPEAR PHARMACEUTICALS INC TRETINOIN, TRETINOIN SPECTRUM PHARMS * SPECTRUM PHARMACEUTICALS INC FUSILEV, LEVOLEUCOVORIN CALCIUM STAND HOMEOPATH * STANDARD HOMEOPATHIC CO IVY BLOCK, BENTOQUATAM (OTC) STASON PHARMS * STASON PHARMACEUTICALS INC CYPROHEPTADINE HYDROCHLORIDE, CYPROHEPTADINE HYDROCHLORIDE STERI PHARMA B - 102 DECEMBER 2013 - APPROVED DRUG PRODUCT LIST APPENDIX B - PRODUCT NAME SORTED BY APPLICANT ** S ** * STERI PHARMA LLC CEFAZOLIN SODIUM, CEFAZOLIN SODIUM CEFTRIAXONE, CEFTRIAXONE SODIUM CEFUROXIME SODIUM, CEFUROXIME SODIUM STI PHARMA LLC * STI PHARMA LLC BETAMETHASONE VALERATE, BETAMETHASONE VALERATE DEXAMETHASONE, DEXAMETHASONE ESCITALOPRAM OXALATE, ESCITALOPRAM OXALATE MYAMBUTOL, ETHAMBUTOL HYDROCHLORIDE SULFATRIM PEDIATRIC, SULFAMETHOXAZOLE TRIACIN-C, CODEINE PHOSPHATE STIEFEL * STIEFEL LABORATORIES INC DUAC, BENZOYL PEROXIDE STIEFEL GSK * STIEFEL A GSK CO VELTIN, CLINDAMYCIN PHOSPHATE STIEFEL LABS INC * STIEFEL LABORATORIES INC EXTINA, KETOCONAZOLE FABIOR, TAZAROTENE OLUX, CLOBETASOL PROPIONATE SORIATANE, ACITRETIN SORILUX, CALCIPOTRIENE VUSION, MICONAZOLE NITRATE STRIDES * STRIDES INC NEVIRAPINE, NEVIRAPINE STRIDES ARCOLAB * STRIDES ARCOLAB LIMITED FOSPHENYTOIN SODIUM, FOSPHENYTOIN SODIUM STRIDES ARCOLAB LTD * STRIDES ARCOLAB LTD ACARBOSE, ACARBOSE ADENOSINE, ADENOSINE CEFTRIAXONE, CEFTRIAXONE SODIUM ERGOCALCIFEROL, ERGOCALCIFEROL ETOMIDATE, ETOMIDATE HYDRALAZINE HYDROCHLORIDE, HYDRALAZINE HYDROCHLORIDE IBUPROFEN AND DIPHENHYDRAMINE HYDROCHLORIDE, DIPHENHYDRAMINE HYDROCHLORIDE (OTC) MELOXICAM, MELOXICAM MYCOPHENOLATE MOFETIL, MYCOPHENOLATE MOFETIL VANCOMYCIN HYDROCHLORIDE, VANCOMYCIN HYDROCHLORIDE SUCAMPO PHARMS * SUCAMPO PHARMACEUTICALS INC AMITIZA, LUBIPROSTONE RESCULA, UNOPROSTONE ISOPROPYL SUN PHARM INDS * SUN PHARMACEUTICAL INDUSTRIES LTD CARBIDOPA AND LEVODOPA, CARBIDOPA CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY, FEXOFENADINE HYDROCHLORIDE (OTC) CHILDREN'S FEXOFENADINE HYDROCHLORIDE HIVES, FEXOFENADINE HYDROCHLORIDE (OTC) DESLORATADINE, DESLORATADINE DESMOPRESSIN ACETATE, DESMOPRESSIN ACETATE DIVALPROEX SODIUM, DIVALPROEX SODIUM DONEPEZIL HYDROCHLORIDE, DONEPEZIL HYDROCHLORIDE DOXORUBICIN HYDROCHLORIDE, DOXORUBICIN HYDROCHLORIDE EPINASTINE HYDROCHLORIDE, EPINASTINE HYDROCHLORIDE EXTENDED PHENYTOIN SODIUM, PHENYTOIN SODIUM FEXOFENADINE HYDROCHLORIDE ALLERGY, FEXOFENADINE HYDROCHLORIDE (OTC) FEXOFENADINE HYDROCHLORIDE HIVES, FEXOFENADINE HYDROCHLORIDE (OTC) METOPROLOL TARTRATE AND HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE OCTREOTIDE ACETATE, OCTREOTIDE ACETATE OLANZAPINE, OLANZAPINE B - 103 DECEMBER 2013 - APPROVED DRUG PRODUCT LIST APPENDIX B - B - 104 PRODUCT NAME SORTED BY APPLICANT ** S ** * SUN PHARMACEUTICAL INDUSTRIES LTD ONDANSETRON, ONDANSETRON OXCARBAZEPINE, OXCARBAZEPINE RIVASTIGMINE TARTRATE, RIVASTIGMINE TARTRATE SUMATRIPTAN SUCCINATE, SUMATRIPTAN SUCCINATE TIAGABINE HYDROCHLORIDE, TIAGABINE HYDROCHLORIDE 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 SERTRALINE HYDROCHLORIDE, SERTRALINE HYDROCHLORIDE ZONISAMIDE, ZONISAMIDE SUN PHARM INDS INC * SUN PHARMACEUTICAL INDUSTRIES INC ERGOCALCIFEROL, ERGOCALCIFEROL HYDROCODONE BITARTRATE AND IBUPROFEN, HYDROCODONE BITARTRATE LITHIUM CARBONATE, LITHIUM CARBONATE NIMODIPINE, NIMODIPINE OXYCODONE HYDROCHLORIDE, OXYCODONE HYDROCHLORIDE PRAMIPEXOLE DIHYDROCHLORIDE, PRAMIPEXOLE DIHYDROCHLORIDE VALPROIC ACID, VALPROIC ACID SUN PHARM INDS LTD * SUN PHARMACEUTICAL INDUSTRIES LTD AZITHROMYCIN, AZITHROMYCIN CARISOPRODOL, CARISOPRODOL CETIRIZINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE, CETIRIZINE HYDROCHLORIDE DESMOPRESSIN ACETATE, DESMOPRESSIN ACETATE GABAPENTIN, GABAPENTIN LETROZOLE, LETROZOLE LEVETIRACETAM, LEVETIRACETAM NARATRIPTAN, NARATRIPTAN ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE, ONDANSETRON HYDROCHLORIDE QUINAPRIL HYDROCHLORIDE, QUINAPRIL HYDROCHLORIDE RILUZOLE, RILUZOLE RISPERIDONE, RISPERIDONE TAMSULOSIN HYDROCHLORIDE, TAMSULOSIN HYDROCHLORIDE TESTOSTERONE CYPIONATE, TESTOSTERONE CYPIONATE TOPIRAMATE, TOPIRAMATE TOPOTECAN HYDROCHLORIDE, TOPOTECAN HYDROCHLORIDE VALPROIC ACID, VALPROIC ACID * SUN PHARMACEUTICAL INDUSTRIES LTD. ANASTROZOLE, ANASTROZOLE SUN PHARMA GLOBAL * SUN PHARMA GLOBAL FZE AZELASTINE HYDROCHLORIDE, AZELASTINE HYDROCHLORIDE BUPROPION HYDROCHLORIDE, BUPROPION HYDROCHLORIDE CAFFEINE CITRATE, CAFFEINE CITRATE CARBIDOPA, LEVODOPA AND ENTACAPONE, CARBIDOPA CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY, CETIRIZINE HYDROCHLORIDE (OTC) CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF, CETIRIZINE HYDROCHLORIDE (OTC) CHLOROTHIAZIDE SODIUM, CHLOROTHIAZIDE SODIUM CLOPIDOGREL BISULFATE, CLOPIDOGREL BISULFATE DESMOPRESSIN ACETATE , DESMOPRESSIN ACETATE DILTIAZEM HYDROCHLORIDE, DILTIAZEM HYDROCHLORIDE DOCEFREZ, DOCETAXEL DOXORUBICIN HYDROCHLORIDE (LIPOSOMAL), DOXORUBICIN HYDROCHLORIDE DULOXETINE HYDROCHLORIDE, DULOXETINE HYDROCHLORIDE ENTACAPONE, ENTACAPONE ESOMEPRAZOLE SODIUM, ESOMEPRAZOLE SODIUM ESZOPICLONE, ESZOPICLONE FINASTERIDE, FINASTERIDE GALANTAMINE HYDROBROMIDE, GALANTAMINE HYDROBROMIDE DECEMBER 2013 - APPROVED DRUG PRODUCT LIST APPENDIX B - PRODUCT NAME SORTED BY APPLICANT ** S ** * SUN PHARMA GLOBAL FZE LANSOPRAZOLE, LANSOPRAZOLE LEVETIRACETAM, LEVETIRACETAM LEVOCETIRIZINE DIHYDROCHLORIDE, LEVOCETIRIZINE DIHYDROCHLORIDE NALTREXONE HYDROCHLORIDE, NALTREXONE HYDROCHLORIDE OXALIPLATIN, OXALIPLATIN QUETIAPINE FUMARATE, QUETIAPINE FUMARATE RIZATRIPTAN BENZOATE, RIZATRIPTAN BENZOATE SUMATRIPTAN SUCCINATE, SUMATRIPTAN SUCCINATE TRAMADOL HYDROCHLORIDE, TRAMADOL HYDROCHLORIDE VENLAFAXINE HYDROCHLORIDE, VENLAFAXINE HYDROCHLORIDE ZOLEDRONIC ACID, ZOLEDRONIC ACID * SUN PHARMA GLOBAL INC ALENDRONATE SODIUM, ALENDRONATE SODIUM ALFUZOSIN HYDROCHLORIDE, ALFUZOSIN HYDROCHLORIDE ALPRAZOLAM, ALPRAZOLAM AMIFOSTINE, AMIFOSTINE AZELASTINE HYDROCHLORIDE, AZELASTINE HYDROCHLORIDE BICALUTAMIDE, BICALUTAMIDE CARBOPLATIN, CARBOPLATIN FOSPHENYTOIN SODIUM, FOSPHENYTOIN SODIUM GEMCITABINE HYDROCHLORIDE, GEMCITABINE HYDROCHLORIDE IRINOTECAN HYDROCHLORIDE, IRINOTECAN HYDROCHLORIDE KETOROLAC TROMETHAMINE, KETOROLAC TROMETHAMINE LEUPROLIDE ACETATE, LEUPROLIDE ACETATE NICARDIPINE HYDROCHLORIDE, NICARDIPINE HYDROCHLORIDE PAMIDRONATE DISODIUM, PAMIDRONATE DISODIUM PANTOPRAZOLE SODIUM, PANTOPRAZOLE SODIUM VECURONIUM BROMIDE, VECURONIUM BROMIDE SUNEVA MEDCL * SUNEVA MEDICAL INC TRETINOIN, TRETINOIN SUNOVION * SUNOVION PHARMACEUTICALS INC BROVANA, ARFORMOTEROL TARTRATE XOPENEX HFA, LEVALBUTEROL TARTRATE XOPENEX, LEVALBUTEROL HYDROCHLORIDE SUNOVION PHARMS INC * SUNOVION PHARMACEUTICALS INC APTIOM, ESLICARBAZEPINE ACETATE LATUDA, LURASIDONE HYDROCHLORIDE LUNESTA, ESZOPICLONE SUNSHINE LAKE * SUNSHINE LAKE PHARMA CO LTD ZIDOVUDINE, ZIDOVUDINE SUNSTAR AMERICAS * SUNSTAR AMERICAS INC PAROEX, CHLORHEXIDINE GLUCONATE SUPERNUS PHARMS * SUPERNUS PHARMACEUTICALS INC OXTELLAR XR, OXCARBAZEPINE TROKENDI XR, TOPIRAMATE SUVEN LIFE * SUVEN LIFE SCIENCES LTD MALATHION, MALATHION SVADS HOLDINGS SA * SVADS HOLDINGS SA IBUPROFEN, IBUPROFEN (OTC) RANITIDINE HYDROCHLORIDE, RANITIDINE HYDROCHLORIDE (OTC) SVC PHARMA * SVC PHARMA LP DRONABINOL, DRONABINOL SWEDISH ORPHAN * SWEDISH ORPHAN BIOVITRUM AB PUBL B - 105 DECEMBER 2013 - APPROVED DRUG PRODUCT LIST APPENDIX B - PRODUCT NAME SORTED BY APPLICANT ** S ** * SWEDISH ORPHAN BIOVITRUM AB PUBL ORFADIN, NITISINONE SYNTHON PHARMS * SYNTHON PHARMACEUTICALS INC LEVOCETIRIZINE DIHYDROCHLORIDE, LEVOCETIRIZINE DIHYDROCHLORIDE PIOGLITAZONE HYDROCHLORIDE, PIOGLITAZONE HYDROCHLORIDE TAMSULOSIN HYDROCHLORIDE, TAMSULOSIN HYDROCHLORIDE ZOLPIDEM TARTRATE, ZOLPIDEM TARTRATE ** T ** MEDICINES CO * THE MEDICINES CO ANGIOMAX, BIVALIRUDIN CLEVIPREX, CLEVIDIPINE RITEDOSE CORP * THE RITEDOSE CORP ALBUTEROL SULFATE AND IPRATROPIUM BROMIDE, ALBUTEROL SULFATE ALBUTEROL SULFATE, ALBUTEROL SULFATE IPRATROPIUM BROMIDE, IPRATROPIUM BROMIDE TAKEDA GMBH * TAKEDA GMBH ALVESCO, CICLESONIDE OMNARIS, CICLESONIDE ZETONNA, CICLESONIDE TAKEDA PHARMS * TAKEDA PHARMACEUTICALS NORTH AMERICA INC DEXILANT, DEXLANSOPRAZOLE TAKEDA PHARMS USA * TAKEDA PHARMACEUTICALS USA INC ACTOPLUS MET XR, METFORMIN HYDROCHLORIDE ACTOPLUS MET, METFORMIN HYDROCHLORIDE ACTOS, PIOGLITAZONE HYDROCHLORIDE BRINTELLIX, VORTIOXETINE HYDROBROMIDE COLCRYS, COLCHICINE DUETACT, GLIMEPIRIDE KAZANO, ALOGLIPTIN BENZOATE NESINA, ALOGLIPTIN BENZOATE OSENI, ALOGLIPTIN BENZOATE PREVACID, LANSOPRAZOLE PREVPAC, AMOXICILLIN ROZEREM, RAMELTEON ULORIC, FEBUXOSTAT TALON THERAP * TALON THERAPEUTICS INC MARQIBO KIT, VINCRISTINE SULFATE TAMARANG * TAMARANG SA ROCURONIUM BROMIDE, ROCURONIUM BROMIDE 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) ENALAPRIL MALEATE, ENALAPRIL MALEATE ETODOLAC, ETODOLAC EXTENDED PHENYTOIN SODIUM, PHENYTOIN SODIUM FLUCONAZOLE, FLUCONAZOLE FLUOROURACIL, FLUOROURACIL GABAPENTIN, GABAPENTIN HYDROCORTISONE BUTYRATE, HYDROCORTISONE BUTYRATE B - 106 DECEMBER 2013 - APPROVED DRUG PRODUCT LIST APPENDIX B - PRODUCT NAME SORTED BY APPLICANT ** T ** * TARO PHARMACEUTICAL INDUSTRIES LTD IMIQUIMOD, IMIQUIMOD 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 CLOTRIMAZOLE, CLOTRIMAZOLE DIFLORASONE DIACETATE, DIFLORASONE DIACETATE FLUOCINONIDE, FLUOCINONIDE HYDROCORTISONE VALERATE, HYDROCORTISONE VALERATE TOPICORT, DESOXIMETASONE * TARO PHARMACEUTICALS USA INC ALCLOMETASONE DIPROPIONATE, ALCLOMETASONE DIPROPIONATE AMIODARONE HYDROCHLORIDE, AMIODARONE HYDROCHLORIDE AMMONIUM LACTATE, AMMONIUM LACTATE BETAMETHASONE DIPROPIONATE, BETAMETHASONE DIPROPIONATE CICLOPIROX, CICLOPIROX CIPROFLOXACIN HYDROCHLORIDE, CIPROFLOXACIN HYDROCHLORIDE CLOBETASOL PROPIONATE, CLOBETASOL PROPIONATE CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE, BETAMETHASONE DIPROPIONATE CLOTRIMAZOLE, CLOTRIMAZOLE DIFLORASONE DIACETATE, DIFLORASONE DIACETATE ECONAZOLE NITRATE, ECONAZOLE NITRATE ESCITALOPRAM OXALATE, ESCITALOPRAM OXALATE FLO-PRED, PREDNISOLONE ACETATE FLUOCINONIDE EMULSIFIED BASE, FLUOCINONIDE FLUOCINONIDE, FLUOCINONIDE FLUOROURACIL, FLUOROURACIL GRANISETRON HYDROCHLORIDE, GRANISETRON HYDROCHLORIDE HALOBETASOL PROPIONATE, HALOBETASOL PROPIONATE KETOZOLE, KETOCONAZOLE LORATADINE, LORATADINE (OTC) MICONAZOLE 3, MICONAZOLE NITRATE (OTC) MOMETASONE FUROATE, MOMETASONE FUROATE MUPIROCIN, MUPIROCIN NYSTATIN AND TRIAMCINOLONE ACETONIDE, NYSTATIN NYSTATIN, NYSTATIN PROMETHAZINE HYDROCHLORIDE, PROMETHAZINE HYDROCHLORIDE RANITIDINE HYDROCHLORIDE, RANITIDINE HYDROCHLORIDE RISPERIDONE, RISPERIDONE SULFACETAMIDE SODIUM, SULFACETAMIDE SODIUM TERBINAFINE HYDROCHLORIDE, TERBINAFINE HYDROCHLORIDE (OTC) TERCONAZOLE, TERCONAZOLE TERIL, CARBAMAZEPINE TOPICORT, DESOXIMETASONE TRIAMCINOLONE ACETONIDE, TRIAMCINOLONE ACETONIDE TRIVAGIZOLE 3, CLOTRIMAZOLE (OTC) U-CORT, HYDROCORTISONE ACETATE * TARO PHARMACEUTICALS, INC. HYDROCORTISONE VALERATE, HYDROCORTISONE VALERATE TOPICORT, DESOXIMETASONE 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 B - 107 DECEMBER 2013 - APPROVED DRUG PRODUCT LIST APPENDIX B - PRODUCT NAME SORTED BY APPLICANT ** T ** * TARO PHARMACEUTICAL INDUSTRIES LTD HYDROCORTISONE BUTYRATE, HYDROCORTISONE BUTYRATE LAMOTRIGINE, LAMOTRIGINE LEVOCETIRIZINE DIHYDROCHLORIDE, LEVOCETIRIZINE DIHYDROCHLORIDE 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 ACETAMINOPHEN, ACETAMINOPHEN (OTC) INFANTS' FEVERALL, ACETAMINOPHEN (OTC) OVIDE, MALATHION TOPICORT, DESOXIMETASONE TEDOR PHARM * TEDOR PHARMA INC BENZPHETAMINE HYDROCHLORIDE, BENZPHETAMINE HYDROCHLORIDE TEDOR PHARMA INC * TEDOR PHARMA INC ORPHENADRINE CITRATE, ORPHENADRINE CITRATE TEIKOKU PHARMA USA * TEIKOKU PHARMA USA INC LIDODERM, LIDOCAINE TEVA * TEVA NEUROSCIENCE INC AZILECT, RASAGILINE MESYLATE * TEVA PHARMACEUTICALS USA INC ACETAMINOPHEN AND CODEINE PHOSPHATE, ACETAMINOPHEN ALBUTEROL SULFATE, ALBUTEROL SULFATE AMLODIPINE BESYLATE, AMLODIPINE BESYLATE AMOXICILLIN AND CLAVULANATE POTASSIUM, AMOXICILLIN AMOXICILLIN, AMOXICILLIN AMPHETAMINE ASP AMPHETAMINE SULF DEXTROAMPHET SACCHARATE & DEXTR SULF, AMPHETAMINE ATENOLOL, ATENOLOL AZITHROMYCIN, AZITHROMYCIN BENAZEPRIL HYDROCHLORIDE, BENAZEPRIL HYDROCHLORIDE BICALUTAMIDE, BICALUTAMIDE BUSPIRONE HYDROCHLORIDE, BUSPIRONE HYDROCHLORIDE CALCITRIOL, CALCITRIOL CARVEDILOL, CARVEDILOL CEFACLOR, CEFACLOR CEFPROZIL, CEFPROZIL CEFUROXIME AXETIL, CEFUROXIME AXETIL CEPHALEXIN, CEPHALEXIN CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY, FEXOFENADINE HYDROCHLORIDE (OTC) CHILDREN'S FEXOFENADINE HYDROCHLORIDE HIVES, FEXOFENADINE HYDROCHLORIDE (OTC) CILOSTAZOL, CILOSTAZOL CLARITHROMYCIN, CLARITHROMYCIN CLEMASTINE FUMARATE, CLEMASTINE FUMARATE CLINDAMYCIN HYDROCHLORIDE, CLINDAMYCIN HYDROCHLORIDE CLOMIPRAMINE HYDROCHLORIDE, CLOMIPRAMINE HYDROCHLORIDE CLOPIDOGREL BISULFATE, CLOPIDOGREL BISULFATE DIFLUNISAL, DIFLUNISAL DIVALPROEX SODIUM, DIVALPROEX SODIUM DONEPEZIL HYDROCHLORIDE, DONEPEZIL HYDROCHLORIDE DOXAZOSIN MESYLATE, DOXAZOSIN MESYLATE ENALAPRIL MALEATE AND HYDROCHLOROTHIAZIDE, ENALAPRIL MALEATE ESTAZOLAM, ESTAZOLAM ETODOLAC, ETODOLAC FAMOTIDINE, FAMOTIDINE FAMOTIDINE, FAMOTIDINE (OTC) FENOFIBRATE (MICRONIZED), FENOFIBRATE FENOFIBRATE, FENOFIBRATE FEXOFENADINE HYDROCHLORIDE ALLERGY, FEXOFENADINE HYDROCHLORIDE (OTC) B - 108 DECEMBER 2013 - APPROVED DRUG PRODUCT LIST APPENDIX B - PRODUCT NAME SORTED BY APPLICANT ** T ** * TEVA PHARMACEUTICALS USA INC FEXOFENADINE HYDROCHLORIDE HIVES, FEXOFENADINE HYDROCHLORIDE (OTC) FEXOFENADINE HYDROCHLORIDE, FEXOFENADINE HYDROCHLORIDE FINASTERIDE, FINASTERIDE FLUCONAZOLE, FLUCONAZOLE FLUOCINONIDE EMULSIFIED BASE, FLUOCINONIDE FLUOCINONIDE, FLUOCINONIDE FLUOXETINE HYDROCHLORIDE, FLUOXETINE HYDROCHLORIDE FLUVOXAMINE MALEATE, FLUVOXAMINE MALEATE FOSINOPRIL SODIUM, FOSINOPRIL SODIUM GLIMEPIRIDE, GLIMEPIRIDE GLYBURIDE, GLYBURIDE HYDROCODONE BITARTRATE AND IBUPROFEN, HYDROCODONE BITARTRATE IRBESARTAN AND HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE KETOCONAZOLE, KETOCONAZOLE KETOPROFEN, KETOPROFEN LAMOTRIGINE, LAMOTRIGINE LEVOFLOXACIN, LEVOFLOXACIN LORATADINE, LORATADINE (OTC) LOSARTAN POTASSIUM, LOSARTAN POTASSIUM LOVASTATIN, LOVASTATIN MESALAMINE, MESALAMINE METFORMIN HYDROCHLORIDE, METFORMIN HYDROCHLORIDE MEXILETINE HYDROCHLORIDE, MEXILETINE HYDROCHLORIDE MINOCYCLINE HYDROCHLORIDE, MINOCYCLINE HYDROCHLORIDE MIRTAZAPINE, MIRTAZAPINE MOEXIPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE MOEXIPRIL HYDROCHLORIDE, MOEXIPRIL HYDROCHLORIDE MUPIROCIN, MUPIROCIN NABUMETONE, NABUMETONE NEFAZODONE HYDROCHLORIDE, NEFAZODONE HYDROCHLORIDE NEOMYCIN SULFATE, NEOMYCIN SULFATE NIZATIDINE, NIZATIDINE NYSTATIN, NYSTATIN OFLOXACIN, OFLOXACIN ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE, ONDANSETRON HYDROCHLORIDE ONDANSETRON HYDROCHLORIDE, ONDANSETRON HYDROCHLORIDE ONDANSETRON, ONDANSETRON OXAPROZIN, OXAPROZIN OXYMORPHONE HYDROCHLORIDE, OXYMORPHONE HYDROCHLORIDE PANTOPRAZOLE SODIUM, PANTOPRAZOLE SODIUM PAROXETINE HYDROCHLORIDE, PAROXETINE HYDROCHLORIDE PENICILLIN-VK, PENICILLIN V POTASSIUM PRAVASTATIN SODIUM, PRAVASTATIN SODIUM PRELONE, PREDNISOLONE PURINETHOL, MERCAPTOPURINE QUINAPRIL HYDROCHLORIDE, QUINAPRIL HYDROCHLORIDE RIBAVIRIN, RIBAVIRIN RISPERIDONE, RISPERIDONE ROPINIROLE HYDROCHLORIDE, ROPINIROLE HYDROCHLORIDE ROSIGLITAZONE MALEATE, ROSIGLITAZONE MALEATE SERTRALINE HYDROCHLORIDE, SERTRALINE HYDROCHLORIDE SOTALOL HYDROCHLORIDE, SOTALOL HYDROCHLORIDE SULFAMETHOXAZOLE AND TRIMETHOPRIM DOUBLE STRENGTH, SULFAMETHOXAZOLE 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 TRIMETHOPRIM, TRIMETHOPRIM VENLAFAXINE HYDROCHLORIDE, VENLAFAXINE HYDROCHLORIDE ZOLPIDEM TARTRATE, ZOLPIDEM TARTRATE B - 109 DECEMBER 2013 - APPROVED DRUG PRODUCT LIST APPENDIX B - PRODUCT NAME SORTED BY APPLICANT ** T ** TEVA BRANDED PHARM * TEVA BRANDED PHARMACEUTICAL PRODUCTS R AND D INC CENESTIN, ESTROGENS, CONJUGATED SYNTHETIC A LOSEASONIQUE, ETHINYL ESTRADIOL MIRCETTE, DESOGESTREL NORDETTE-28, ETHINYL ESTRADIOL PLAN B ONE-STEP, LEVONORGESTREL (OTC) PLAN B, LEVONORGESTREL PLAN B, LEVONORGESTREL (OTC) PROAIR HFA, ALBUTEROL SULFATE PROGLYCEM, DIAZOXIDE QNASL, BECLOMETHASONE DIPROPIONATE QUARTETTE, ETHINYL ESTRADIOL QVAR 40, BECLOMETHASONE DIPROPIONATE QVAR 80, BECLOMETHASONE DIPROPIONATE SEASONALE, ETHINYL ESTRADIOL SEASONIQUE, ETHINYL ESTRADIOL TEVA PHARMS * TEVA PHARMACEUTICALS USA ALBUTEROL SULFATE AND IPRATROPIUM BROMIDE, ALBUTEROL SULFATE ALBUTEROL SULFATE, ALBUTEROL SULFATE ALENDRONATE SODIUM, ALENDRONATE SODIUM ALFUZOSIN HYDROCHLORIDE, ALFUZOSIN HYDROCHLORIDE AMIODARONE HYDROCHLORIDE, AMIODARONE HYDROCHLORIDE AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE, AMLODIPINE BESYLATE AMLODIPINE,VALSARTAN AND HYDROCHLOROTHIAZIDE, AMLODIPINE ANASTROZOLE, ANASTROZOLE AZITHROMYCIN, AZITHROMYCIN BISOPROLOL FUMARATE, BISOPROLOL FUMARATE BUDESONIDE, BUDESONIDE CARBAMAZEPINE, CARBAMAZEPINE CEFADROXIL, CEFADROXIL/CEFADROXIL HEMIHYDRATE CEFDINIR, CEFDINIR CEFPROZIL, CEFPROZIL CEFUROXIME SODIUM, CEFUROXIME SODIUM CETIRIZINE HYDROCHLORIDE, CETIRIZINE HYDROCHLORIDE CITALOPRAM HYDROBROMIDE, CITALOPRAM HYDROBROMIDE CLOBETASOL PROPIONATE, CLOBETASOL PROPIONATE CLOPIDOGREL BISULFATE, CLOPIDOGREL BISULFATE CROMOLYN SODIUM, CROMOLYN SODIUM DESMOPRESSIN ACETATE, DESMOPRESSIN ACETATE DEXMETHYLPHENIDATE HYDROCHLORIDE, DEXMETHYLPHENIDATE HYDROCHLORIDE DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE, DORZOLAMIDE HYDROCHLORIDE DORZOLAMIDE HYDROCHLORIDE, DORZOLAMIDE HYDROCHLORIDE DOXEPIN HYDROCHLORIDE, DOXEPIN HYDROCHLORIDE ETHOSUXIMIDE, ETHOSUXIMIDE FAMCICLOVIR, FAMCICLOVIR FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, FLUCONAZOLE FLUVASTATIN SODIUM, FLUVASTATIN SODIUM GABAPENTIN, GABAPENTIN GALANTAMINE HYDROBROMIDE, GALANTAMINE HYDROBROMIDE GEMCITABINE HYDROCHLORIDE, GEMCITABINE HYDROCHLORIDE GLIPIZIDE AND METFORMIN HYDROCHLORIDE, GLIPIZIDE GRANISETRON HYDROCHLORIDE, GRANISETRON HYDROCHLORIDE HALOPERIDOL, HALOPERIDOL LACTATE HYDROCORTISONE, HYDROCORTISONE HYDROXYCHLOROQUINE SULFATE, HYDROXYCHLOROQUINE SULFATE IRBESARTAN, IRBESARTAN LAMIVUDINE AND ZIDOVUDINE, LAMIVUDINE LANSOPRAZOLE, LANSOPRAZOLE LEFLUNOMIDE, LEFLUNOMIDE LETROZOLE, LETROZOLE LEVETIRACETAM, LEVETIRACETAM LEVOCETIRIZINE DIHYDROCHLORIDE, LEVOCETIRIZINE DIHYDROCHLORIDE LINEZOLID, LINEZOLID B - 110 DECEMBER 2013 - APPROVED DRUG PRODUCT LIST APPENDIX B - PRODUCT NAME SORTED BY APPLICANT ** T ** * TEVA PHARMACEUTICALS USA LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE MEBENDAZOLE, MEBENDAZOLE MEGESTROL ACETATE, MEGESTROL ACETATE MELOXICAM, MELOXICAM METHAZOLAMIDE, METHAZOLAMIDE METHYLPHENIDATE HYDROCHLORIDE, METHYLPHENIDATE HYDROCHLORIDE MONTELUKAST SODIUM, MONTELUKAST SODIUM MYCOPHENOLATE MOFETIL, MYCOPHENOLATE MOFETIL NARATRIPTAN, NARATRIPTAN HYDROCHLORIDE OLANZAPINE AND FLUOXETINE HYDROCHLORIDE, FLUOXETINE HYDROCHLORIDE OLANZAPINE, OLANZAPINE OXALIPLATIN, OXALIPLATIN PACLITAXEL, PACLITAXEL PRAMIPEXOLE DIHYDROCHLORIDE, PRAMIPEXOLE DIHYDROCHLORIDE PRAVASTATIN SODIUM, PRAVASTATIN SODIUM PRAZOSIN HYDROCHLORIDE, PRAZOSIN HYDROCHLORIDE PREGABALIN, PREGABALIN PROCHLORPERAZINE MALEATE, PROCHLORPERAZINE MALEATE PROGESTERONE, PROGESTERONE QUETIAPINE FUMARATE, QUETIAPINE FUMARATE QUINIDINE SULFATE, QUINIDINE SULFATE QUININE SULFATE, QUININE SULFATE RAMIPRIL, RAMIPRIL RISEDRONATE SODIUM, RISEDRONATE SODIUM RIZATRIPTAN BENZOATE, RIZATRIPTAN BENZOATE ROCURONIUM BROMIDE, ROCURONIUM BROMIDE SILDENAFIL CITRATE, SILDENAFIL CITRATE SULFAMETHOXAZOLE AND TRIMETHOPRIM SINGLE STRENGTH, SULFAMETHOXAZOLE TAMOXIFEN CITRATE, TAMOXIFEN CITRATE TAMSULOSIN HYDROCHLORIDE, TAMSULOSIN HYDROCHLORIDE TESTOSTERONE, TESTOSTERONE THEOPHYLLINE, THEOPHYLLINE TRANDOLAPRIL, TRANDOLAPRIL TRIAMCINOLONE ACETONIDE, TRIAMCINOLONE ACETONIDE URSODIOL, URSODIOL VALACYCLOVIR HYDROCHLORIDE, VALACYCLOVIR HYDROCHLORIDE VALPROIC ACID, VALPROIC ACID VANDAZOLE, METRONIDAZOLE VARDENAFIL HYDROCHLORIDE, VARDENAFIL HYDROCHLORIDE VORICONAZOLE, VORICONAZOLE ZALEPLON, ZALEPLON TEVA PHARMS USA * TEVA PHARMACEUTICALS USA ACITRETIN, ACITRETIN ADENOSINE, ADENOSINE ALPROSTADIL, ALPROSTADIL AMIKACIN SULFATE, AMIKACIN SULFATE BLEOMYCIN SULFATE, BLEOMYCIN SULFATE CARBOPLATIN, CARBOPLATIN CEFTRIAXONE, CEFTRIAXONE SODIUM CLARAVIS, ISOTRETINOIN COPAXONE, GLATIRAMER ACETATE CYTOSAR-U, CYTARABINE DACARBAZINE, DACARBAZINE DAUNORUBICIN HYDROCHLORIDE, DAUNORUBICIN HYDROCHLORIDE DESMOPRESSIN ACETATE, DESMOPRESSIN ACETATE DESVENLAFAXINE FUMARATE, DESVENLAFAXINE FUMARATE DEXMETHYLPHENIDATE HYDROCHLORIDE, DEXMETHYLPHENIDATE HYDROCHLORIDE DILTIAZEM HYDROCHLORIDE, DILTIAZEM HYDROCHLORIDE DOXORUBICIN HYDROCHLORIDE, DOXORUBICIN HYDROCHLORIDE DULOXETINE HYDROCHLORIDE, DULOXETINE HYDROCHLORIDE ENALAPRILAT, ENALAPRILAT EPIRUBICIN HYDROCHLORIDE, EPIRUBICIN HYDROCHLORIDE EPOPROSTENOL SODIUM, EPOPROSTENOL SODIUM B - 111 DECEMBER 2013 - APPROVED DRUG PRODUCT LIST APPENDIX B - PRODUCT NAME SORTED BY APPLICANT ** T ** * TEVA PHARMACEUTICALS USA ETOPOSIDE, ETOPOSIDE FLUCONAZOLE IN SODIUM CHLORIDE 0.9%, FLUCONAZOLE FLUDARABINE PHOSPHATE, FLUDARABINE PHOSPHATE FLUOROURACIL, FLUOROURACIL FLUOXETINE HYDROCHLORIDE, FLUOXETINE HYDROCHLORIDE GRANISETRON HYDROCHLORIDE, GRANISETRON HYDROCHLORIDE HALOPERIDOL DECANOATE, HALOPERIDOL DECANOATE HALOPERIDOL, HALOPERIDOL LACTATE IDARUBICIN HYDROCHLORIDE PFS, IDARUBICIN HYDROCHLORIDE IFOSFAMIDE, IFOSFAMIDE IFOSFAMIDE/MESNA KIT, IFOSFAMIDE IRINOTECAN HYDROCHLORIDE, IRINOTECAN HYDROCHLORIDE LANSOPRAZOLE, AMOXICILLIN AND CLARITHROMYCIN, AMOXICILLIN LEUCOVORIN CALCIUM, LEUCOVORIN CALCIUM LEUPROLIDE ACETATE, LEUPROLIDE ACETATE LEVALBUTEROL HYDROCHLORIDE, LEVALBUTEROL HYDROCHLORIDE LEVOCARNITINE, LEVOCARNITINE MEDROXYPROGESTERONE ACETATE, MEDROXYPROGESTERONE ACETATE MESNA, MESNA METHYLPREDNISOLONE ACETATE, METHYLPREDNISOLONE ACETATE METOCLOPRAMIDE HYDROCHLORIDE, METOCLOPRAMIDE HYDROCHLORIDE MITOXANTRONE HYDROCHLORIDE, MITOXANTRONE HYDROCHLORIDE NOREPINEPHRINE BITARTRATE, NOREPINEPHRINE BITARTRATE OCTREOTIDE ACETATE, OCTREOTIDE ACETATE PAMIDRONATE DISODIUM, PAMIDRONATE DISODIUM PANCURONIUM BROMIDE, PANCURONIUM BROMIDE PARICALCITOL, PARICALCITOL PIOGLITAZONE HYDROCHLORIDE, PIOGLITAZONE HYDROCHLORIDE PROMETHAZINE HYDROCHLORIDE, PROMETHAZINE HYDROCHLORIDE PROPOFOL, PROPOFOL RAMELTEON, RAMELTEON SULFAMETHOXAZOLE AND TRIMETHOPRIM, SULFAMETHOXAZOLE SUMATRIPTAN SUCCINATE, SUMATRIPTAN SUCCINATE TOBRAMYCIN SULFATE, TOBRAMYCIN SULFATE TOBRAMYCIN, TOBRAMYCIN TOPOTECAN HYDROCHLORIDE, TOPOTECAN HYDROCHLORIDE VECURONIUM BROMIDE, VECURONIUM BROMIDE VINCRISTINE SULFATE PFS, VINCRISTINE SULFATE VINORELBINE TARTRATE, VINORELBINE TARTRATE ZANOSAR, STREPTOZOCIN * TEVA PHARMACEUTICALS USA INC AMOXICILLIN AND CLAVULANATE POTASSIUM, AMOXICILLIN CAPECITABINE, CAPECITABINE ESTRADIOL AND NORETHINDRONE ACETATE, ESTRADIOL IMIQUIMOD, IMIQUIMOD METRONIDAZOLE, METRONIDAZOLE OXYBUTYNIN CHLORIDE, OXYBUTYNIN CHLORIDE RABEPRAZOLE SODIUM, RABEPRAZOLE SODIUM TRAZODONE HYDROCHLORIDE, TRAZODONE HYDROCHLORIDE TEVA PHARMS USA INC * TEVA PHARMACEUTICALS USA INC ADASUVE, LOXAPINE TEVA WOMENS * TEVA WOMENS HEALTH INC ENJUVIA, ESTROGENS, CONJUGATED SYNTHETIC B PARAGARD T 380A, COPPER PREFEST, ESTRADIOL REVIA, NALTREXONE HYDROCHLORIDE ZEBETA, BISOPROLOL FUMARATE ZIAC, BISOPROLOL FUMARATE THE PHARMA NETWORK * THE PHARMA NETWORK LLC BENZONATATE, BENZONATATE THE PHARMANETWORK B - 112 DECEMBER 2013 - APPROVED DRUG PRODUCT LIST APPENDIX B - PRODUCT NAME SORTED BY APPLICANT ** T ** * THE PHARMANETWORK LLC METHADONE HYDROCHLORIDE, METHADONE HYDROCHLORIDE THEPHARMANETWORK LLC * THEPHARMANETWORK LLC THERMAZENE, SILVER SULFADIAZINE THERAVANCE INC * THERAVANCE INC VIBATIV, TELAVANCIN HYDROCHLORIDE THREE RIVERS PHARMS * THREE RIVERS PHARMACEUTICALS LLC ANASTROZOLE, ANASTROZOLE RIBASPHERE, RIBAVIRIN RIBAVIRIN, RIBAVIRIN TOPOTECAN HYDROCHLORIDE, TOPOTECAN HYDROCHLORIDE TOLMAR * TOLMAR INC ADAPALENE, ADAPALENE ATRIDOX, DOXYCYCLINE HYCLATE CALCIPOTRIENE AND BETAMETHASONE DIPROPIONATE, BETAMETHASONE DIPROPIONATE CALCIPOTRIENE, CALCIPOTRIENE CICLOPIROX, CICLOPIROX DICLOFENAC SODIUM , DICLOFENAC SODIUM IMIQUIMOD, IMIQUIMOD LEVETIRACETAM, LEVETIRACETAM METRONIDAZOLE, METRONIDAZOLE MOMETASONE FUROATE, MOMETASONE FUROATE RANITIDINE HYDROCHLORIDE, RANITIDINE HYDROCHLORIDE TOLMAR THERAP * TOLMAR THERAPEUTICS INC ELIGARD, LEUPROLIDE ACETATE TORPHARM * TORPHARM INC RANITIDINE HYDROCHLORIDE, RANITIDINE HYDROCHLORIDE (OTC) TORRENT PHARM * TORRENT PHARMA INC METFORMIN HYDROCHLORIDE, METFORMIN HYDROCHLORIDE TORRENT PHARMS * TORRENT PHARMACEUTICALS LIMITED LEVOFLOXACIN, LEVOFLOXACIN * TORRENT PHARMACEUTICALS LTD AMLODIPINE BESYLATE, AMLODIPINE BESYLATE CARBAMAZEPINE, CARBAMAZEPINE CITALOPRAM HYDROBROMIDE, CITALOPRAM HYDROBROMIDE DONEPEZIL HYDROCHLORIDE, DONEPEZIL HYDROCHLORIDE ISOSORBIDE MONONITRATE, ISOSORBIDE MONONITRATE LAMOTRIGINE, LAMOTRIGINE LEVETIRACETAM, LEVETIRACETAM LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE LOSARTAN POTASSIUM, LOSARTAN POTASSIUM METFORMIN HYDROCHLORIDE, METFORMIN HYDROCHLORIDE PANTOPRAZOLE SODIUM, PANTOPRAZOLE SODIUM PRAMIPEXOLE DIHYDROCHLORIDE, PRAMIPEXOLE DIHYDROCHLORIDE RISPERIDONE, RISPERIDONE SERTRALINE HYDROCHLORIDE, SERTRALINE HYDROCHLORIDE TOPIRAMATE, TOPIRAMATE ZOLPIDEM TARTRATE, ZOLPIDEM TARTRATE * TORRENT PHARMACEUTICALS LTD. ALFUZOSIN HYDROCHLORIDE, ALFUZOSIN HYDROCHLORIDE TORRENT PHARMS LLC * TORRENT PHARMACEUTICALS LLC CETIRIZINE HYDROCHLORIDE ALLERGY, CETIRIZINE HYDROCHLORIDE (OTC) CETIRIZINE HYDROCHLORIDE HIVES RELIEF, CETIRIZINE HYDROCHLORIDE (OTC) OLANZAPINE, OLANZAPINE VENLAFAXINE HYDROCHLORIDE, VENLAFAXINE HYDROCHLORIDE B - 113 DECEMBER 2013 - APPROVED DRUG PRODUCT LIST APPENDIX B - B - 114 PRODUCT NAME SORTED BY APPLICANT ** T ** TORRENT PHARMS LTD * TORRENT PHARMACEUTICALS LTD CLOPIDOGREL BISULFATE, CLOPIDOGREL BISULFATE DULOXETINE HYDROCHLORIDE, DULOXETINE HYDROCHLORIDE ESCITALOPRAM OXALATE, ESCITALOPRAM OXALATE FELODIPINE, FELODIPINE LAMOTRIGINE, LAMOTRIGINE LEVETIRACETAM, LEVETIRACETAM MONTELUKAST SODIUM, MONTELUKAST SODIUM OLANZAPINE, OLANZAPINE PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE, METFORMIN HYDROCHLORIDE PIOGLITAZONE HYDROCHLORIDE, PIOGLITAZONE HYDROCHLORIDE QUETIAPINE FUMARATE, QUETIAPINE FUMARATE RABEPRAZOLE SODIUM, RABEPRAZOLE SODIUM SILDENAFIL CITRATE, SILDENAFIL CITRATE TELMISARTAN AND AMLODIPINE, AMLODIPINE BESYLATE TRAZODONE HYDROCHLORIDE, TRAZODONE HYDROCHLORIDE TRIS PHARMA INC * TRIS PHARMA INC CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY, CETIRIZINE HYDROCHLORIDE (OTC) CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF, CETIRIZINE HYDROCHLORIDE (OTC) DEXTROAMPHETAMINE SULFATE, DEXTROAMPHETAMINE SULFATE DEXTROMETHORPHAN POLISTIREX, DEXTROMETHORPHAN POLISTIREX (OTC) HYDROCODONE BITARTRATE AND ACETAMINOPHEN, ACETAMINOPHEN HYDROCODONE POLISTIREX AND CHLORPHENIRAMINE POLISTIREX, CHLORPHENIRAMINE POLISTIREX IBUPROFEN, IBUPROFEN (OTC) KARBINAL ER, CARBINOXAMINE MALEATE LEVETIRACETAM, LEVETIRACETAM METHYLPHENIDATE HYDROCHLORIDE, METHYLPHENIDATE HYDROCHLORIDE PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE, CODEINE PHOSPHATE PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE, DEXTROMETHORPHAN PROMETHAZINE HYDROCHLORIDE, PROMETHAZINE HYDROCHLORIDE RISPERIDONE, RISPERIDONE THEOPHYLLINE, THEOPHYLLINE TWI PHARMS INC * TWI PHARMACEUTICALS INC CYCLOBENZAPRINE HYDROCHLORIDE, CYCLOBENZAPRINE HYDROCHLORIDE ** U ** UCB INC * UCB INC KEPPRA XR, LEVETIRACETAM KEPPRA, LEVETIRACETAM LORTAB, ACETAMINOPHEN METADATE CD, METHYLPHENIDATE HYDROCHLORIDE NEUPRO, ROTIGOTINE NIRAVAM, ALPRAZOLAM PARCOPA, CARBIDOPA TUSSIONEX PENNKINETIC, CHLORPHENIRAMINE POLISTIREX UNIRETIC, HYDROCHLOROTHIAZIDE UNIVASC, MOEXIPRIL HYDROCHLORIDE VIMPAT, LACOSAMIDE XYZAL, LEVOCETIRIZINE DIHYDROCHLORIDE UCLA BIOMEDICAL * UCLA BIOMEDICAL CYCLOTRON AMMONIA N 13, AMMONIA N-13 FLUDEOXYGLUCOSE F18, FLUDEOXYGLUCOSE F-18 UCYCLYD * UCYCLYD PHARMA INC AMMONUL, SODIUM BENZOATE UNICHEM * UNICHEM LABORATORIES LTD BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE, BISOPROLOL FUMARATE CETIRIZINE HYDROCHLORIDE ALLERGY, CETIRIZINE HYDROCHLORIDE (OTC) CETIRIZINE HYDROCHLORIDE HIVES, CETIRIZINE HYDROCHLORIDE (OTC) DECEMBER 2013 - APPROVED DRUG PRODUCT LIST APPENDIX B - PRODUCT NAME SORTED BY APPLICANT ** U ** * UNICHEM LABORATORIES LTD CLONIDINE HYDROCHLORIDE, CLONIDINE HYDROCHLORIDE HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE MELOXICAM, MELOXICAM ZALEPLON, ZALEPLON UNICHEM LABS LTD * UNICHEM LABORATORIES LIMITED DIVALPROEX SODIUM, DIVALPROEX SODIUM * UNICHEM LABORATORIES LTD AMLODIPINE BESYLATE, AMLODIPINE BESYLATE LAMOTRIGINE, LAMOTRIGINE TIZANIDINE HYDROCHLORIDE, TIZANIDINE HYDROCHLORIDE TOPIRAMATE, TOPIRAMATE UNICHEM PHARMS (USA) * UNICHEM PHARMACEUTICALS (USA) INC BISOPROLOL FUMARATE, BISOPROLOL FUMARATE 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 TINIDAZOLE, TINIDAZOLE UNITED BIOMEDCL * UNITED BIOMEDICAL INC TERBUTALINE SULFATE, TERBUTALINE SULFATE UNITED GUARDIAN * UNITED GUARDIAN INC RENACIDIN, CITRIC ACID UNITED THERAP * UNITED THERAPEUTICS CORP ORENITRAM, TREPROSTINIL REMODULIN, TREPROSTINIL TYVASO, TREPROSTINIL UNIV TX MD ANDERSON * UNIV TEXAS MD ANDERSON CANCER CENTER FLUDEOXYGLUCOSE F18, FLUDEOXYGLUCOSE F-18 SODIUM FLUORIDE F-18, SODIUM FLUORIDE F-18 UPSHER SMITH * UPSHER SMITH LABORATORIES INC AMLODIPINE BESYLATE, AMLODIPINE BESYLATE BETHANECHOL CHLORIDE, BETHANECHOL CHLORIDE DIVALPROEX SODIUM, DIVALPROEX SODIUM DIVIGEL, ESTRADIOL FORTICAL, CALCITONIN SALMON RECOMBINANT LAMOTRIGINE, LAMOTRIGINE LOSARTAN POTASSIUM, LOSARTAN POTASSIUM MORPHINE SULFATE, MORPHINE SULFATE NIACOR, NIACIN NYSTATIN, NYSTATIN ORVATEN, MIDODRINE HYDROCHLORIDE OXANDROLONE, OXANDROLONE PACERONE, AMIODARONE HYDROCHLORIDE PREVALITE, CHOLESTYRAMINE PROPRANOLOL HYDROCHLORIDE, PROPRANOLOL HYDROCHLORIDE SORINE, SOTALOL HYDROCHLORIDE TOPIRAMATE, TOPIRAMATE ZALEPLON, ZALEPLON UPSHER SMITH LABS * UPSHER SMITH LABORATORIES INC KLOR-CON M10, POTASSIUM CHLORIDE KLOR-CON M15, POTASSIUM CHLORIDE KLOR-CON M20, POTASSIUM CHLORIDE B - 115 DECEMBER 2013 - APPROVED DRUG PRODUCT LIST APPENDIX B - PRODUCT NAME SORTED BY APPLICANT ** U ** UPSHER-SMITH LABS * UPSHER-SMITH LABORATORIES INC KLOR-CON, POTASSIUM CHLORIDE US PHARMS HOLDINGS I * US PHARMACEUTICALS HOLDINGS I LLC LOPRESSOR HCT, HYDROCHLOROTHIAZIDE LOPRESSOR, METOPROLOL TARTRATE LOTENSIN HCT, BENAZEPRIL HYDROCHLORIDE LOTENSIN, BENAZEPRIL HYDROCHLORIDE METHERGINE, METHYLERGONOVINE MALEATE PARLODEL, BROMOCRIPTINE MESYLATE US WORLDMEDS * US WORLDMEDS LLC APOKYN, APOMORPHINE HYDROCHLORIDE DANTROLENE SODIUM, DANTROLENE SODIUM USL PHARMA * USL PHARMA INC AMANTADINE HYDROCHLORIDE, AMANTADINE HYDROCHLORIDE BENZTROPINE MESYLATE, BENZTROPINE MESYLATE ESTRADIOL, ESTRADIOL FLUOXYMESTERONE, FLUOXYMESTERONE JANTOVEN, WARFARIN SODIUM ** V ** VALEANT * VALEANT PHARMACEUTICALS INTERNATIONAL ANCOBON, FLUCYTOSINE BONTRIL PDM, PHENDIMETRAZINE TARTRATE BONTRIL, PHENDIMETRAZINE TARTRATE D.H.E. 45, DIHYDROERGOTAMINE MESYLATE DIASTAT ACUDIAL, DIAZEPAM DIASTAT, DIAZEPAM MIGRANAL, DIHYDROERGOTAMINE MESYLATE MOTOFEN, ATROPINE SULFATE MYSOLINE, PRIMIDONE PHRENILIN FORTE, ACETAMINOPHEN PHRENILIN WITH CAFFEINE AND CODEINE, ACETAMINOPHEN VALEANT BERMUDA * VALEANT INTERNATIONAL BERMUDA APLENZIN, BUPROPION HYDROBROMIDE BENZACLIN, BENZOYL PEROXIDE CARAC, FLUOROURACIL DERMATOP E EMOLLIENT, PREDNICARBATE DERMATOP, PREDNICARBATE ELIDEL, PIMECROLIMUS ISORDIL, ISOSORBIDE DINITRATE KLARON, SULFACETAMIDE SODIUM NORITATE, METRONIDAZOLE PENLAC, CICLOPIROX RETIN-A, TRETINOIN VENLAFAXINE HYDROCHLORIDE, VENLAFAXINE HYDROCHLORIDE XENAZINE, TETRABENAZINE XERESE, ACYCLOVIR ZOVIRAX, ACYCLOVIR VALEANT INTL * VALEANT INTERNATIONAL BARBADOS SRL ATIVAN, LORAZEPAM CARDIZEM CD, DILTIAZEM HYDROCHLORIDE CARDIZEM LA, DILTIAZEM HYDROCHLORIDE CARDIZEM, DILTIAZEM HYDROCHLORIDE DICLOFENAC SODIUM, DICLOFENAC SODIUM DILTIAZEM HYDROCHLORIDE, DILTIAZEM HYDROCHLORIDE FENOFIBRATE, FENOFIBRATE NIFEDIPINE, NIFEDIPINE PENTOXIFYLLINE, PENTOXIFYLLINE B - 116 DECEMBER 2013 - APPROVED DRUG PRODUCT LIST APPENDIX B - PRODUCT NAME SORTED BY APPLICANT ** V ** * VALEANT INTERNATIONAL BARBADOS SRL RENOVA, TRETINOIN RETIN-A MICRO, TRETINOIN RETIN-A, TRETINOIN TIAZAC, DILTIAZEM HYDROCHLORIDE ULTRAM ER, TRAMADOL HYDROCHLORIDE VASERETIC, ENALAPRIL MALEATE VASOTEC, ENALAPRIL MALEATE WELLBUTRIN XL, BUPROPION HYDROCHLORIDE * VALEANT INTERNATIONAL SRL BENZAMYCIN, BENZOYL PEROXIDE VALEANT LUXEMBOURG * VALEANT PHARMACEUTICALS LUXEMBOURG SARL BENZAMYCIN PAK, BENZOYL PEROXIDE ERTACZO, SERTACONAZOLE NITRATE GRIFULVIN V, GRISEOFULVIN, MICROSIZE TARGRETIN, BEXAROTENE VALEANT PHARM INTL * VALEANT PHARMACEUTICALS INTERNATIONAL ANDROID 10, METHYLTESTOSTERONE ANDROID 25, METHYLTESTOSTERONE EFUDEX, FLUOROURACIL TESTRED, METHYLTESTOSTERONE ZELAPAR, SELEGILINE HYDROCHLORIDE VALEANT PHARMS * VALEANT PHARMACEUTICALS NORTH AMERICA MEPHYTON, PHYTONADIONE TENSILON PRESERVATIVE FREE, EDROPHONIUM CHLORIDE TENSILON, EDROPHONIUM CHLORIDE VALEANT PHARMS INC * VALEANT PHARMACEUTICALS INTERNATIONAL INC VISUDYNE, VERTEPORFIN VALEANT PHARMS LLC * VALEANT PHARMACEUTICALS NORTH AMERICA LLC CAPITAL AND CODEINE, ACETAMINOPHEN MACUGEN, PEGAPTANIB SODIUM MESTINON, PYRIDOSTIGMINE BROMIDE TASMAR, TOLCAPONE TIMOPTIC-XE, TIMOLOL MALEATE VALIDUS PHARMS * VALIDUS PHARMACEUTICALS LLC ROCALTROL, CALCITRIOL VALIDUS PHARMS INC * VALIDUS PHARMACEUTICALS INC EQUETRO, CARBAMAZEPINE MARPLAN, ISOCARBOXAZID VANSEN PHARMA * VANSEN PHARMA SPECTRACEF, CEFDITOREN PIVOXIL VEROSCIENCE * VEROSCIENCE LLC CYCLOSET, BROMOCRIPTINE MESYLATE VERSAPHARM * VERSAPHARM INC CICLOPIROX, CICLOPIROX CLINDAMYCIN PHOSPHATE, CLINDAMYCIN PHOSPHATE DEMECLOCYCLINE HYDROCHLORIDE, DEMECLOCYCLINE HYDROCHLORIDE DESOXIMETASONE, DESOXIMETASONE ERYTHROMYCIN, ERYTHROMYCIN ETHOSUXIMIDE, ETHOSUXIMIDE RIFAMPIN, RIFAMPIN VERSAPHARM INC * VERSAPHARM INC RIFAMPIN, RIFAMPIN B - 117 DECEMBER 2013 - APPROVED DRUG PRODUCT LIST APPENDIX B - PRODUCT NAME SORTED BY APPLICANT ** V ** * VERSAPHARM INC TRIAMCINOLONE ACETONIDE, TRIAMCINOLONE ACETONIDE * VERSAPHARM INCORPORATED TRANEXAMIC ACID, TRANEXAMIC ACID VERTEX PHARMS * VERTEX PHARMACEUTICALS INC INCIVEK, TELAPREVIR KALYDECO, IVACAFTOR VESTIQ PHARMS * VESTIQ PHARMACEUTICALS INC ORAVIG, MICONAZOLE ZUPLENZ, ONDANSETRON VICURON * VICURON PHARMACEUTICALS INC ERAXIS, ANIDULAFUNGIN VIFOR FRESENIUS * VIFOR FRESENIUS MEDICAL CARE RENAL PHARMA FRANCE VELPHORO, SUCROFERRIC OXYHYDROXIDE VIIV HLTHCARE * VIIV HEALTHCARE CO COMBIVIR, LAMIVUDINE EPIVIR, LAMIVUDINE EPZICOM, ABACAVIR SULFATE LEXIVA, FOSAMPRENAVIR CALCIUM RESCRIPTOR, DELAVIRDINE MESYLATE RETROVIR, ZIDOVUDINE SELZENTRY, MARAVIROC TIVICAY, DOLUTEGRAVIR SODIUM 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 FOLIC ACID, FOLIC ACID GLIMEPIRIDE, GLIMEPIRIDE GLYCOPYRROLATE, GLYCOPYRROLATE HYDROCORTISONE AND ACETIC ACID, ACETIC ACID, GLACIAL HYDROCORTISONE, HYDROCORTISONE LIDOCAINE HYDROCHLORIDE VISCOUS, LIDOCAINE HYDROCHLORIDE LIDOCAINE HYDROCHLORIDE, LIDOCAINE HYDROCHLORIDE LISINOPRIL, LISINOPRIL NYSTATIN, NYSTATIN PHENYLEPHRINE HYDROCHLORIDE AND PROMETHAZINE HYDROCHLORIDE, PHENYLEPHRINE PREDNISOLONE SODIUM PHOSPHATE, PREDNISOLONE SODIUM PHOSPHATE PREDNISOLONE, PREDNISOLONE PROMETH HYDROCHLORIDE,PHENYLEPHRINE HYDROCHLORIDE W/CODEINE PHOSPHATE, CODEINE PROMETHAZINE DM, DEXTROMETHORPHAN HYDROBROMIDE PROMETHAZINE HYDROCHLORIDE, PROMETHAZINE HYDROCHLORIDE PROMETHAZINE WITH CODEINE, CODEINE PHOSPHATE RISPERIDONE, RISPERIDONE SPIRONOLACTONE, SPIRONOLACTONE SULFAMETHOXAZOLE AND TRIMETHOPRIM, SULFAMETHOXAZOLE TRAZODONE HYDROCHLORIDE, TRAZODONE HYDROCHLORIDE TRIAMCINOLONE ACETONIDE, TRIAMCINOLONE ACETONIDE VALPROIC ACID, VALPROIC ACID VENLAFAXINE HYDROCHLORIDE, VENLAFAXINE HYDROCHLORIDE B - 118 DECEMBER 2013 - APPROVED DRUG PRODUCT LIST APPENDIX B - PRODUCT NAME SORTED BY APPLICANT ** V ** * VINTAGE PHARMACEUTICALS LLC ZOLPIDEM TARTRATE, ZOLPIDEM TARTRATE VINTAGE PHARMS * VINTAGE PHARMACEUTICALS DISULFIRAM, DISULFIRAM GILDAGIA, ETHINYL ESTRADIOL GRISEOFULVIN, GRISEOFULVIN, MICROSIZE LEVETIRACETAM, LEVETIRACETAM PROPRANOLOL HYDROCHLORIDE, PROPRANOLOL HYDROCHLORIDE * VINTAGE PHARMACEUTICALS INC ACETAMINOPHEN AND CODEINE PHOSPHATE, ACETAMINOPHEN ALLOPURINOL, ALLOPURINOL BACLOFEN, BACLOFEN BUTALBITAL, ACETAMINOPHEN AND CAFFEINE, ACETAMINOPHEN BUTALBITAL, ACETAMINOPHEN, CAFFEINE AND CODEINE PHOSPHATE, ACETAMINOPHEN CLONAZEPAM, CLONAZEPAM CYCLOBENZAPRINE HYDROCHLORIDE, CYCLOBENZAPRINE HYDROCHLORIDE DEXAMETHASONE, DEXAMETHASONE DIAZEPAM, DIAZEPAM 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) ISOSORBIDE MONONITRATE, ISOSORBIDE MONONITRATE LACTULOSE, LACTULOSE LEVETIRACETAM, LEVETIRACETAM LORAZEPAM, LORAZEPAM METHOCARBAMOL, METHOCARBAMOL METOCLOPRAMIDE HYDROCHLORIDE, METOCLOPRAMIDE HYDROCHLORIDE NYSTATIN, NYSTATIN OXYBUTYNIN CHLORIDE, OXYBUTYNIN CHLORIDE OXYCODONE AND ACETAMINOPHEN, ACETAMINOPHEN OXYCODONE HYDROCHLORIDE, OXYCODONE HYDROCHLORIDE PHENTERMINE HYDROCHLORIDE, PHENTERMINE HYDROCHLORIDE PREDNISONE, PREDNISONE PRIMIDONE, PRIMIDONE PROMETHAZINE HYDROCHLORIDE, PROMETHAZINE HYDROCHLORIDE PROPAFENONE HYDROCHLORIDE, PROPAFENONE HYDROCHLORIDE RANITIDINE HYDROCHLORIDE, RANITIDINE HYDROCHLORIDE SOTALOL HYDROCHLORIDE, SOTALOL HYDROCHLORIDE SULFASALAZINE, SULFASALAZINE TORSEMIDE, TORSEMIDE VINTAGE PHARMS LLC * VINTAGE PHARMACEUTICALS LLC CYCLAFEM 1/35, ETHINYL ESTRADIOL CYCLAFEM 7/7/7, ETHINYL ESTRADIOL EMOQUETTE, DESOGESTREL FELODIPINE, FELODIPINE GILDESS FE 1.5/30, ETHINYL ESTRADIOL GILDESS FE 1/20, ETHINYL ESTRADIOL LETROZOLE, LETROZOLE LEVETIRACETAM, LEVETIRACETAM MONTELUKAST SODIUM, MONTELUKAST SODIUM MORPHINE SULFATE, MORPHINE SULFATE MYCOPHENOLATE MOFETIL, MYCOPHENOLATE MOFETIL MYZILRA, ETHINYL ESTRADIOL ORSYTHIA, ETHINYL ESTRADIOL PERCOCET, ACETAMINOPHEN PREVIFEM, ETHINYL ESTRADIOL TRI-PREVIFEM, ETHINYL ESTRADIOL ZYDONE, ACETAMINOPHEN B - 119 DECEMBER 2013 - APPROVED DRUG PRODUCT LIST APPENDIX B - PRODUCT NAME SORTED BY APPLICANT ** V ** VIROPHARMA * VIROPHARMA INC VANCOCIN HYDROCHLORIDE, VANCOMYCIN HYDROCHLORIDE VIRTUS PHARM * VIRTUS PHARMACEUTICAL INC ACARBOSE , ACARBOSE VISTA PHARMS * VISTA PHARMACEUTICALS INC SULFAMETHOXAZOLE AND TRIMETHOPRIM, SULFAMETHOXAZOLE VISTAPHARM * VISTAPHARM INC ALBUTEROL SULFATE, ALBUTEROL SULFATE HYDROCODONE BITARTRATE AND ACETAMINOPHEN, ACETAMINOPHEN LACTULOSE, LACTULOSE METHADONE HYDROCHLORIDE, METHADONE HYDROCHLORIDE METOCLOPRAMIDE HYDROCHLORIDE, METOCLOPRAMIDE HYDROCHLORIDE MORPHINE SULFATE, MORPHINE SULFATE NYSTATIN, NYSTATIN OXYCODONE HYDROCHLORIDE, OXYCODONE HYDROCHLORIDE PHENYTOIN, PHENYTOIN VIVIMED LABS * VIVIMED LABS ALATHUR PRIVATE LTD DONEPEZIL HYDROCHLORIDE, DONEPEZIL HYDROCHLORIDE LOSARTAN POTASSIUM, LOSARTAN POTASSIUM VIVUS * VIVUS INC QSYMIA, PHENTERMINE HYDROCHLORIDE STENDRA, AVANAFIL ** W ** WARNER CHILCOTT * WARNER CHILCOTT CO LLC LO MINASTRIN FE, ETHINYL ESTRADIOL NORETHINDRONE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE, * WARNER CHILCOTT INC LOESTRIN 24 FE, ETHINYL ESTRADIOL LOESTRIN FE 1/20, ETHINYL ESTRADIOL WARNER CHILCOTT LLC * WARNER CHILCOTT CO LLC ACTONEL, RISEDRONATE SODIUM ASACOL HD, MESALAMINE ASACOL, MESALAMINE ATELVIA, RISEDRONATE SODIUM CHOLEDYL SA, OXTRIPHYLLINE DELZICOL, MESALAMINE ENABLEX, DARIFENACIN HYDROBROMIDE ESTROSTEP FE, ETHINYL ESTRADIOL FEMCON FE, ETHINYL ESTRADIOL FEMHRT, ETHINYL ESTRADIOL FEMTRACE, ESTRADIOL ACETATE LO LOESTRIN FE, ETHINYL ESTRADIOL LOESTRIN 21 1.5/30, ETHINYL ESTRADIOL LOESTRIN 21 1/20, ETHINYL ESTRADIOL LOESTRIN FE 1.5/30, ETHINYL ESTRADIOL MINASTRIN 24 FE, ETHINYL ESTRADIOL OVCON-35, ETHINYL ESTRADIOL SARAFEM, FLUOXETINE HYDROCHLORIDE WARNER CHILCOTT US * WARNER CHILCOTT US LLC ESTRACE, ESTRADIOL WARNER IRELAND * WARNER CHILCOTT IRELAND LTD FEMRING, ESTRADIOL ACETATE WATSON LABS ETHINYL ESTRADIOL B - 120 DECEMBER 2013 - APPROVED DRUG PRODUCT LIST APPENDIX B - PRODUCT NAME SORTED BY APPLICANT ** W ** * WATSON LABORATORIES ACETAMINOPHEN AND PENTAZOCINE HYDROCHLORIDE, ACETAMINOPHEN ANASTROZOLE, ANASTROZOLE 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 PIOGLITAZONE HYDROCHLORIDE, PIOGLITAZONE HYDROCHLORIDE PROPAFENONE HYDROCHLORIDE, PROPAFENONE HYDROCHLORIDE TRAMADOL HYDROCHLORIDE, TRAMADOL HYDROCHLORIDE * WATSON LABORATORIES INC ACARBOSE, ACARBOSE ACETOHEXAMIDE, ACETOHEXAMIDE AFEDITAB CR, NIFEDIPINE ALBUTEROL SULFATE AND IPRATROPIUM BROMIDE, ALBUTEROL SULFATE ALBUTEROL SULFATE, ALBUTEROL SULFATE ALENDRONATE SODIUM, ALENDRONATE SODIUM ALORA, ESTRADIOL AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE, AMLODIPINE BESYLATE AMLODIPINE BESYLATE, AMLODIPINE BESYLATE AMOXAPINE, AMOXAPINE ANDRODERM, TESTOSTERONE BUPROPION HYDROCHLORIDE, BUPROPION HYDROCHLORIDE BUTALBITAL, ACETAMINOPHEN AND CAFFEINE, ACETAMINOPHEN CABERGOLINE, CABERGOLINE CARBOPLATIN, CARBOPLATIN CHLORZOXAZONE, CHLORZOXAZONE CIPROFLOXACIN HYDROCHLORIDE, CIPROFLOXACIN HYDROCHLORIDE CITALOPRAM HYDROBROMIDE, CITALOPRAM HYDROBROMIDE CLINDAMYCIN HYDROCHLORIDE, CLINDAMYCIN HYDROCHLORIDE COL-PROBENECID, COLCHICINE CRINONE, PROGESTERONE CROMOLYN SODIUM, CROMOLYN SODIUM CYCLOBENZAPRINE HYDROCHLORIDE, CYCLOBENZAPRINE HYDROCHLORIDE CYCLOSPORINE, CYCLOSPORINE DEFEROXAMINE MESYLATE, DEFEROXAMINE MESYLATE DESMOPRESSIN ACETATE, DESMOPRESSIN ACETATE DESOGESTREL AND ETHINYL ESTRADIOL, DESOGESTREL DILACOR XR, DILTIAZEM HYDROCHLORIDE DOXYCYCLINE, DOXYCYCLINE DROSPIRENONE AND ETHINYL ESTRADIOL, DROSPIRENONE ERGOLOID MESYLATES, ERGOLOID MESYLATES FENTANYL CITRATE, FENTANYL CITRATE FENTANYL-100, FENTANYL FENTANYL-25, FENTANYL FENTANYL-50, FENTANYL FENTANYL-75, FENTANYL FOSINOPRIL SODIUM, FOSINOPRIL SODIUM GABAPENTIN, GABAPENTIN GALANTAMINE HYDROBROMIDE, GALANTAMINE HYDROBROMIDE GELNIQUE, OXYBUTYNIN CHLORIDE GLIMEPIRIDE, GLIMEPIRIDE GLIPIZIDE, GLIPIZIDE HYDROCODONE BITARTRATE AND ACETAMINOPHEN, ACETAMINOPHEN IPRATROPIUM BROMIDE, IPRATROPIUM BROMIDE ISRADIPINE, ISRADIPINE LAMOTRIGINE, LAMOTRIGINE LEVONORGESTREL AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL, ETHINYL ESTRADIOL LEVONORGESTREL AND ETHINYL ESTRADIOL, ETHINYL ESTRADIOL B - 121 DECEMBER 2013 - APPROVED DRUG PRODUCT LIST APPENDIX B - PRODUCT NAME SORTED BY APPLICANT ** W ** * WATSON LABORATORIES INC LEVONORGESTREL, LEVONORGESTREL LEVONORGESTREL, LEVONORGESTREL (OTC) LISINOPRIL, LISINOPRIL LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE LOSARTAN POTASSIUM, LOSARTAN POTASSIUM LOW-OGESTREL-21, ETHINYL ESTRADIOL LOXAPINE SUCCINATE, LOXAPINE SUCCINATE MEPROBAMATE, MEPROBAMATE METOCLOPRAMIDE HYDROCHLORIDE, METOCLOPRAMIDE HYDROCHLORIDE METRONIDAZOLE, METRONIDAZOLE MINOXIDIL, MINOXIDIL MIRTAZAPINE, MIRTAZAPINE NABUMETONE, NABUMETONE NALOXONE HYDROCHLORIDE AND PENTAZOCINE HYDROCHLORIDE, NALOXONE HYDROCHLORIDE NATEGLINIDE, NATEGLINIDE NEOMYCIN AND POLYMYXIN B SULFATE, NEOMYCIN SULFATE NICOTINE POLACRILEX, NICOTINE POLACRILEX (OTC) NIZATIDINE, NIZATIDINE NORCO, ACETAMINOPHEN 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+50 28-DAY, MESTRANOL OGESTREL 0.5/50-28, ETHINYL ESTRADIOL OXYCODONE AND ACETAMINOPHEN, ACETAMINOPHEN OXYCODONE AND ASPIRIN, ASPIRIN OXYCODONE AND ASPIRIN, ASPIRIN OXYCODONE HYDROCHLORIDE AND IBUPROFEN, IBUPROFEN PRAMIPEXOLE DIHYDROCHLORIDE, PRAMIPEXOLE DIHYDROCHLORIDE PRAVASTATIN SODIUM, PRAVASTATIN SODIUM PREDNISOLONE, PREDNISOLONE PROMETHAZINE HYDROCHLORIDE, PROMETHAZINE HYDROCHLORIDE QUASENSE, ETHINYL ESTRADIOL QUINIDINE GLUCONATE, QUINIDINE GLUCONATE QUINIDINE SULFATE, QUINIDINE SULFATE RAMIPRIL, RAMIPRIL RAPAFLO, SILODOSIN RISPERIDONE, RISPERIDONE RIVASTIGMINE TARTRATE, RIVASTIGMINE TARTRATE SERTRALINE HYDROCHLORIDE, SERTRALINE HYDROCHLORIDE SIMVASTATIN, SIMVASTATIN SUMATRIPTAN SUCCINATE, SUMATRIPTAN SUCCINATE TACROLIMUS, TACROLIMUS TAMOXIFEN CITRATE, TAMOXIFEN CITRATE TELMISARTAN, TELMISARTAN TETRACYCLINE HYDROCHLORIDE, TETRACYCLINE HYDROCHLORIDE TOPIRAMATE, TOPIRAMATE TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN, ACETAMINOPHEN TRANDOLAPRIL, TRANDOLAPRIL TRELSTAR, TRIPTORELIN PAMOATE TRI-NORINYL 28-DAY, ETHINYL ESTRADIOL TRIHEXYPHENIDYL HYDROCHLORIDE, TRIHEXYPHENIDYL HYDROCHLORIDE TRIVORA-28, ETHINYL ESTRADIOL VALACYCLOVIR HYDROCHLORIDE, VALACYCLOVIR HYDROCHLORIDE VANCOMYCIN HYDROCHLORIDE, VANCOMYCIN HYDROCHLORIDE ZOLPIDEM TARTRATE, ZOLPIDEM TARTRATE 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 B - 122 DECEMBER 2013 - APPROVED DRUG PRODUCT LIST APPENDIX B - PRODUCT NAME SORTED BY APPLICANT ** W ** * WATSON LABORATORIES INC OXYTROL, OXYBUTYNIN PROGESTERONE, PROGESTERONE WATSON LABS FLORIDA * WATSON LABORATORIES INC FLORIDA ALPRAZOLAM, ALPRAZOLAM BUPROPION HYDROCHLORIDE, BUPROPION HYDROCHLORIDE CIPROFLOXACIN EXTENDED RELEASE, CIPROFLOXACIN DILTIAZEM HYDROCHLORIDE, DILTIAZEM HYDROCHLORIDE DIVALPROEX SODIUM, DIVALPROEX SODIUM DOXYCYCLINE HYCLATE, DOXYCYCLINE HYCLATE GLIMEPIRIDE, GLIMEPIRIDE HYDROCODONE BITARTRATE AND IBUPROFEN, HYDROCODONE BITARTRATE LEVETIRACETAM, LEVETIRACETAM METFORMIN HYDROCHLORIDE, METFORMIN HYDROCHLORIDE METOPROLOL SUCCINATE, METOPROLOL SUCCINATE POTASSIUM CHLORIDE, POTASSIUM CHLORIDE RISPERIDONE, RISPERIDONE WATSON LABS INC * WATSON LABORATORIES INC ALBUTEROL SULFATE, ALBUTEROL SULFATE AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE, AMLODIPINE BESYLATE AMMONIUM LACTATE, AMMONIUM LACTATE ARMODAFINIL, ARMODAFINIL BUDESONIDE, BUDESONIDE BUPROPION HYDROCHLORIDE, BUPROPION HYDROCHLORIDE CICLOPIROX, CICLOPIROX CYCLOSPORINE, CYCLOSPORINE DEXMETHYLPHENIDATE HYDROCHLORIDE, DEXMETHYLPHENIDATE HYDROCHLORIDE DICLOFENAC SODIUM AND MISOPROSTOL, DICLOFENAC SODIUM FIORICET W/ CODEINE, ACETAMINOPHEN FIORINAL W/CODEINE, ASPIRIN FIORINAL, ASPIRIN GELNIQUE 3%, OXYBUTYNIN IBANDRONATE SODIUM, IBANDRONATE SODIUM INDOMETHACIN, INDOMETHACIN IRBESARTAN AND HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE IRBESARTAN, IRBESARTAN KADIAN, MORPHINE SULFATE LAMOTRIGINE, LAMOTRIGINE LEVALBUTEROL HYDROCHLORIDE, LEVALBUTEROL HYDROCHLORIDE LEVETIRACETAM, LEVETIRACETAM LEVOFLOXACIN, LEVOFLOXACIN LEVONORGESTREL, LEVONORGESTREL LEVONORGESTREL, LEVONORGESTREL (OTC) LIDOCAINE, LIDOCAINE METHYLPHENIDATE HYDROCHLORIDE, METHYLPHENIDATE HYDROCHLORIDE PREGABALIN, PREGABALIN PROMETHAZINE HYDROCHLORIDE, PROMETHAZINE HYDROCHLORIDE RASAGILINE MESYLATE, RASAGILINE MESYLATE ROPINIROLE HYDROCHLORIDE, ROPINIROLE HYDROCHLORIDE SILDENAFIL CITRATE, SILDENAFIL CITRATE URSODIOL, URSODIOL VALSARTAN AND HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE WATSON LABS INC FL * WATSON LABORATORIES INC FLORIDA DOXYCYCLINE HYCLATE, DOXYCYCLINE HYCLATE FLUTAMIDE, FLUTAMIDE TRANEXAMIC ACID, TRANEXAMIC ACID TROSPIUM CHLORIDE, TROSPIUM CHLORIDE ZOLPIDEM TARTRATE, ZOLPIDEM TARTRATE WATSON PHARMS * WATSON PHARMACEUTICALS TENUATE DOSPAN, DIETHYLPROPION HYDROCHLORIDE TENUATE, DIETHYLPROPION HYDROCHLORIDE B - 123 DECEMBER 2013 - APPROVED DRUG PRODUCT LIST APPENDIX B - PRODUCT NAME SORTED BY APPLICANT ** W ** * WATSON PHARMACEUTICALS INC ACTIGALL, URSODIOL WEILL MEDCL COLL * WEILL MEDICAL COLLEGE CORNELL UNIV FLUDEOXYGLUCOSE F18, FLUDEOXYGLUCOSE F-18 WELLSPRING PHARM * WELLSPRING PHARMACEUTICAL CORP DIBENZYLINE, PHENOXYBENZAMINE HYDROCHLORIDE DUVOID, BETHANECHOL CHLORIDE WEST WARD * WEST WARD INC ERGOTAMINE TARTRATE AND CAFFEINE, CAFFEINE ISOSORBIDE DINITRATE, ISOSORBIDE DINITRATE * WEST WARD PHARMACEUTICAL CORP BUTALBITAL, ACETAMINOPHEN AND CAFFEINE, ACETAMINOPHEN BUTALBITAL, ACETAMINOPHEN, CAFFEINE AND CODEINE PHOSPHATE, BUTALBITAL, ASPIRIN AND CAFFEINE, ASPIRIN CHLOROQUINE PHOSPHATE, CHLOROQUINE PHOSPHATE CORTISONE ACETATE, CORTISONE ACETATE DOXYCYCLINE HYCLATE, DOXYCYCLINE HYCLATE HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE HYDROXYCHLOROQUINE SULFATE, HYDROXYCHLOROQUINE SULFATE ISOSORBIDE MONONITRATE, ISOSORBIDE MONONITRATE LITHIUM CARBONATE, LITHIUM CARBONATE PRIMIDONE, PRIMIDONE ZALEPLON, ZALEPLON WEST WARD PHARM CORP * WEST WARD PHARMACEUTICAL CORP NAPROXEN, NAPROXEN PHENYLEPHRINE HYDROCHLORIDE, PHENYLEPHRINE HYDROCHLORIDE WEST WARD PHARMS * WEST WARD PHARMACEUTICALS CORP RISPERIDONE, RISPERIDONE WEST-WARD PHARM CORP * WEST-WARD PHARMACEUTICAL CORP CEFOTETAN, CEFOTETAN DISODIUM FLUDROCORTISONE ACETATE, FLUDROCORTISONE ACETATE WI MEDCL CYCLOTRON * WISCONSIN MEDICAL CYCLOTRON LLC FLUDEOXYGLUCOSE F-18, FLUDEOXYGLUCOSE F-18 WILSHIRE PHARMS INC * WILSHIRE PHARMACEUTICALS INC LAMOTRIGINE, LAMOTRIGINE WOCKHARDT * WOCKHARDT AMERICAS INC FAMOTIDINE, FAMOTIDINE * WOCKHARDT EU OPERATIONS (SWISS) AG BROMFED-DM, BROMPHENIRAMINE MALEATE FLUTICASONE PROPIONATE, FLUTICASONE PROPIONATE LEVETIRACETAM, LEVETIRACETAM LINDANE, LINDANE PHENYTOIN, PHENYTOIN * WOCKHARDT LTD ADENOSINE, ADENOSINE AMIODARONE HYDROCHLORIDE, AMIODARONE HYDROCHLORIDE AMLODIPINE BESYLATE, AMLODIPINE BESYLATE AZITHROMYCIN, AZITHROMYCIN BETAXOLOL HYDROCHLORIDE, BETAXOLOL HYDROCHLORIDE BETHANECHOL CHLORIDE, BETHANECHOL CHLORIDE CEFOTAXIME SODIUM, CEFOTAXIME SODIUM CEFOTAXIME, CEFOTAXIME SODIUM CEFPROZIL, CEFPROZIL CEFTAZIDIME, CEFTAZIDIME CEFTRIAXONE, CEFTRIAXONE SODIUM CEFUROXIME AXETIL, CEFUROXIME AXETIL ACETAMINOPHEN B - 124 DECEMBER 2013 - APPROVED DRUG PRODUCT LIST APPENDIX B - PRODUCT NAME SORTED BY APPLICANT ** W ** * WOCKHARDT LTD CETIRIZINE HYDROCHLORIDE ALLERGY, CETIRIZINE HYDROCHLORIDE (OTC) CETIRIZINE HYDROCHLORIDE, CETIRIZINE HYDROCHLORIDE CLARITHROMYCIN, CLARITHROMYCIN DIVALPROEX SODIUM, DIVALPROEX SODIUM DONEPEZIL HYDROCHLORIDE, DONEPEZIL HYDROCHLORIDE EXTENDED PHENYTOIN SODIUM, PHENYTOIN SODIUM FAMOTIDINE, FAMOTIDINE (OTC) FOSPHENYTOIN SODIUM, FOSPHENYTOIN SODIUM FUROSEMIDE, FUROSEMIDE KETOROLAC TROMETHAMINE, KETOROLAC TROMETHAMINE LEVETIRACETAM, LEVETIRACETAM LEVOFLOXACIN, LEVOFLOXACIN LISINOPRIL, LISINOPRIL METOPROLOL SUCCINATE, METOPROLOL SUCCINATE MIDAZOLAM HYDROCHLORIDE, MIDAZOLAM HYDROCHLORIDE NICARDIPINE HYDROCHLORIDE, NICARDIPINE HYDROCHLORIDE ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE, ONDANSETRON HYDROCHLORIDE ONDANSETRON HYDROCHLORIDE, ONDANSETRON HYDROCHLORIDE PANTOPRAZOLE SODIUM, PANTOPRAZOLE SODIUM PROMETHAZINE HYDROCHLORIDE, PROMETHAZINE HYDROCHLORIDE RANITIDINE HYDROCHLORIDE, RANITIDINE HYDROCHLORIDE RANITIDINE HYDROCHLORIDE, RANITIDINE HYDROCHLORIDE (OTC) RISPERIDONE, RISPERIDONE ROPINIROLE HYDROCHLORIDE, ROPINIROLE HYDROCHLORIDE SERTRALINE HYDROCHLORIDE, SERTRALINE HYDROCHLORIDE SUMATRIPTAN SUCCINATE, SUMATRIPTAN SUCCINATE TAMSULOSIN HYDROCHLORIDE, TAMSULOSIN HYDROCHLORIDE TERBINAFINE HYDROCHLORIDE, TERBINAFINE HYDROCHLORIDE TIMOLOL MALEATE, TIMOLOL MALEATE VALACYCLOVIR HYDROCHLORIDE, VALACYCLOVIR HYDROCHLORIDE VENLAFAXINE HYDROCHLORIDE, VENLAFAXINE HYDROCHLORIDE ZOLPIDEM TARTRATE, ZOLPIDEM TARTRATE ZONISAMIDE, ZONISAMIDE WOCKHARDT EU OPERATN * WOCKHARDT EU OPERATIONS SWISS AG AMOXICILLIN AND CLAVULANATE POTASSIUM, AMOXICILLIN DEXAMETHASONE, DEXAMETHASONE TRIAMCINOLONE ACETONIDE, TRIAMCINOLONE ACETONIDE WOCKHARDT LTD * WOCKHARDT LTD ALFUZOSIN HYDROCHLORIDE, ALFUZOSIN HYDROCHLORIDE BUPROPION HYDROCHLORIDE, BUPROPION HYDROCHLORIDE CARBIDOPA, LEVODOPA AND ENTACAPONE, CARBIDOPA CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY, FEXOFENADINE HYDROCHLORIDE (OTC) CHILDREN'S FEXOFENADINE HYDROCHLORIDE HIVES, FEXOFENADINE HYDROCHLORIDE (OTC) CLOPIDOGREL BISULFATE, CLOPIDOGREL BISULFATE ENTACAPONE, ENTACAPONE FELODIPINE, FELODIPINE FEXOFENADINE HYDROCHLORIDE ALLERGY, FEXOFENADINE HYDROCHLORIDE (OTC) FEXOFENADINE HYDROCHLORIDE HIVES, FEXOFENADINE HYDROCHLORIDE (OTC) LAMOTRIGINE, LAMOTRIGINE LANSOPRAZOLE, LANSOPRAZOLE (OTC) ROPINIROLE HYDROCHLORIDE, ROPINIROLE HYDROCHLORIDE ZIPRASIDONE HYDROCHLORIDE, ZIPRASIDONE HYDROCHLORIDE WOCKHARDT USA * WOCKHARDT USA INC EXTENDED PHENYTOIN SODIUM, PHENYTOIN SODIUM GRANISETRON HYDROCHLORIDE, GRANISETRON HYDROCHLORIDE OCTREOTIDE ACETATE (PRESERVATIVE FREE), OCTREOTIDE ACETATE OCTREOTIDE ACETATE, OCTREOTIDE ACETATE * WOCKHARDT USA LLC ENALAPRIL MALEATE, ENALAPRIL MALEATE LANSOPRAZOLE, LANSOPRAZOLE TOPIRAMATE, TOPIRAMATE B - 125 DECEMBER 2013 - APPROVED DRUG PRODUCT LIST APPENDIX B - PRODUCT NAME SORTED BY APPLICANT ** W ** WORLD GEN * WORLD GEN LLC AMLODIPINE BESYLATE, AMLODIPINE BESYLATE WRASER PHARMS * WRASER PHARMACEUTICALS LLC CETRAXAL, CIPROFLOXACIN HYDROCHLORIDE WYETH PHARMS * WYETH PHARMACEUTICALS INC SUB PFIZER INC LO/OVRAL-28, ETHINYL ESTRADIOL WYETH PHARMS INC * WYETH PHARMACEUTICALS INC BOSULIF, BOSUTINIB MONOHYDRATE CORDARONE, AMIODARONE HYDROCHLORIDE EFFEXOR XR, VENLAFAXINE HYDROCHLORIDE INDERAL, PROPRANOLOL HYDROCHLORIDE INDERIDE-40/25, HYDROCHLOROTHIAZIDE 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 TRECATOR, ETHIONAMIDE ZOSYN IN PLASTIC CONTAINER, PIPERACILLIN SODIUM ZOSYN, PIPERACILLIN SODIUM WYETH PHARMS PFIZER * WYETH PHARMACEUTICALS INC WHOLLY OWNED SUB PFIZER INC DUAVEE, BAZEDOXIFENE ACETATE ** X ** X GEN PHARMS * X GEN PHARMACEUTICALS INC ACETAZOLAMIDE SODIUM, ACETAZOLAMIDE SODIUM AMPHOTERICIN B, AMPHOTERICIN B COLISTIMETHATE SODIUM, COLISTIMETHATE SODIUM HYDRO-RX, HYDROCORTISONE LEVETIRACETAM, LEVETIRACETAM LIOTHYRONINE SODIUM, LIOTHYRONINE SODIUM NEOMYCIN AND POLYMYXIN B SULFATE, NEOMYCIN SULFATE NEOMYCIN SULFATE, NEOMYCIN SULFATE NYSTATIN, NYSTATIN TOBRAMYCIN SULFATE, TOBRAMYCIN SULFATE X-GEN PHARMS * X-GEN PHARMACEUTICALS INC PHENYTOIN SODIUM, PHENYTOIN SODIUM PROMETHAZINE HYDROCHLORIDE, PROMETHAZINE HYDROCHLORIDE X-GEN PHARMS INC * X-GEN PHARMACEUTICALS INC TRANEXAMIC ACID, TRANEXAMIC ACID XELLIA PHARMS APS * XELLIA PHARMACEUTICALS APS POLYMYXIN B SULFATE, POLYMYXIN B SULFATE XENOPORT INC * XENOPORT INC HORIZANT, GABAPENTIN ENACARBIL XOMA * XOMA (US) LLC ACEON, PERINDOPRIL ERBUMINE XSPIRE * XSPIRE LLC NALFON, FENOPROFEN CALCIUM XTTRIUM * XTTRIUM LABORATORIES INC B - 126 DECEMBER 2013 - APPROVED DRUG PRODUCT LIST APPENDIX B - PRODUCT NAME SORTED BY APPLICANT ** * XTTRIUM LABORATORIES INC CHLORHEXIDINE GLUCONATE, X ** CHLORHEXIDINE GLUCONATE ** Y ** Z ** YUNG SHIN PHARM * YUNG SHIN PHARMACEUTICAL INDUSTRIAL CO LTD CEFACLOR, CEFACLOR CEPHALEXIN, CEPHALEXIN ** ZACH SYSTEMS * ZACH SYSTEMS SPA DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE, DORZOLAMIDE HYDROCHLORIDE DORZOLAMIDE HYDROCHLORIDE, DORZOLAMIDE HYDROCHLORIDE ZAMBON SPA * ZAMBON SPA ITALY MONUROL, FOSFOMYCIN TROMETHAMINE ZOGENIX INC * ZOGENIX INC SUMAVEL DOSEPRO, SUMATRIPTAN SUCCINATE ZOHYDRO ER, HYDROCODONE BITARTRATE ZYDUS HLTHCARE * ZYDUS HEALTHCARE USA LLC LANSOPRAZOLE, LANSOPRAZOLE 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 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 ANASTROZOLE, ANASTROZOLE BICALUTAMIDE, BICALUTAMIDE BROMOCRIPTINE MESYLATE, BROMOCRIPTINE MESYLATE CARVEDILOL, CARVEDILOL CLOPIDOGREL BISULFATE, CLOPIDOGREL BISULFATE DIPYRIDAMOLE, DIPYRIDAMOLE DIVALPROEX SODIUM, DIVALPROEX SODIUM DONEPEZIL HYDROCHLORIDE, DONEPEZIL HYDROCHLORIDE DULOXETINE HYDROCHLORIDE, DULOXETINE HYDROCHLORIDE ESCITALOPRAM OXALATE, ESCITALOPRAM OXALATE ETHOSUXIMIDE, ETHOSUXIMIDE FINASTERIDE, FINASTERIDE B - 127 DECEMBER 2013 - APPROVED DRUG PRODUCT LIST APPENDIX B - PRODUCT NAME SORTED BY APPLICANT ** Z ** * ZYDUS PHARMACEUTICALS USA INC GABAPENTIN, GABAPENTIN GALANTAMINE HYDROBROMIDE, GALANTAMINE HYDROBROMIDE GLIPIZIDE AND METFORMIN HYDROCHLORIDE, GLIPIZIDE HYDROXYCHLOROQUINE SULFATE, HYDROXYCHLOROQUINE SULFATE INDOMETHACIN, INDOMETHACIN IRBESARTAN, IRBESARTAN LAMOTRIGINE, LAMOTRIGINE LEVETIRACETAM, LEVETIRACETAM LEVOFLOXACIN, LEVOFLOXACIN LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE LOSARTAN POTASSIUM, LOSARTAN POTASSIUM OMEPRAZOLE, OMEPRAZOLE PIOGLITAZONE HYDROCHLORIDE, PIOGLITAZONE HYDROCHLORIDE PRAMIPEXOLE DIHYDROCHLORIDE, PRAMIPEXOLE DIHYDROCHLORIDE PROPRANOLOL HYDROCHLORIDE, PROPRANOLOL HYDROCHLORIDE RAMIPRIL, RAMIPRIL RANITIDINE HYDROCHLORIDE, RANITIDINE HYDROCHLORIDE RISPERIDONE, RISPERIDONE ROPINIROLE HYDROCHLORIDE, ROPINIROLE HYDROCHLORIDE SIROLIMUS, SIROLIMUS TAMSULOSIN HYDROCHLORIDE, TAMSULOSIN HYDROCHLORIDE TOPIRAMATE, TOPIRAMATE TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN, ACETAMINOPHEN TRAMADOL HYDROCHLORIDE, TRAMADOL HYDROCHLORIDE VENLAFAXINE HYDROCHLORIDE, VENLAFAXINE HYDROCHLORIDE ZOLMITRIPTAN, ZOLMITRIPTAN B - 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