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【原创】FDA ANDA list 2010
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分享2010 FDA 批准的ANDA (非专利药GENERIC)产品清单.希望对大家的工作有所帮助,也请大家加以评论.(原本是打算以附件的形式,但不知怎回事,没找到这个标志.对不起了)Generic Drug Name Generic Manufacturer Brand Name Approval Date 1 DESLORATADINE TABLETS, 5 MG ORCHID HEALTHCARE CLARINEX TABLETS 2/19/2010 2 IMIQUIMOD CREAM, 5% NYCOMED US, INC. ALDARA CREAM 2/25/2010 First-Time Generics - January 2010 Generic Drug Name Generic Manufacturer Brand Name Approval Date 1 IBUTILIDE FUMARATE INJECTION, 0.1 MG/ML (10 ML SINGLE-DOSE VIALS) BIONICHE PHARMA USA, LLC CORVERT, 0.1 MG/ML 1/11/2010 2 IBUTILIDE FUMARATE INJECTION, 0.1 MG/ML (10 ML SINGLE-DOSE VIALS) GENERAMEDIX, INC. CORVERT, 0.1 MG/ML 1/11/2010 3 IBUTILIDE FUMARATE INJECTION, 0.1 MG/ML (10 ML SINGLE-DOSE VIAL) PHARMAFORCE, INC. CORVERT, 0.1 MG/ML 1/11/2010 |
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FDA ANDA list 2009
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First-Time Generics - December 2009 Generic Drug Name Generic Manufacturer Brand Name Approval Date 1 DONEPEZIL HYDROCHLORIDE ORALLY DISINTEGRATING TABLETS, 5 MG AND 10 MG MUTUAL PHARMACEUTICAL CO., INC. ARICEPT ODT, 5 MG AND 10 MG 12/11/2009 2 COSYNTROPIN FOR INJECTION, 0.25 MG/VIAL GENERAMEDIX, INC. CORTROSYN, 0.25 MG/VIAL 12/17/2009 3 CROMOLYN SODIUM ORAL SOLUTION (CONCENTRATE), 100 MG/5 ML GENERA PHARMACEUTICALS, INC. GASTROCROM 12/18/2009 First-Time Generics - November 2009 Generic Drug Name Generic Manufacturer Brand Name Approval Date 1 KETOROLAC TROMETHAMINE OPHTHALMIC SOLUTION, 0.4% APOTEX INC. ACULAR LS OPHTHALMIC SOLUTION 11/5/2009 2 KETOROLAC TROMETHAMINE OPHTHALMIC SOLUTION, 0.5% ALCON INC. ACULAR OPHTHALMIC SOLUTION 11/5/2009 3 KETOROLAC TROMETHAMINE OPHTHALMIC SOLUTION, 0.4% ALCON INC. ACULAR LS OPHTHALMIC SOLUTION 11/5/2009 4 KETOROLAC TROMETHAMINE OPHTHALMIC SOLUTION, 0.5% AKORN INC. ACULAR OPHTHALMIC SOLUTION 11/5/2009 5 KETOROLAC TROMETHAMINE OPHTHALMIC SOLUTION, 0.4% AKORN INC. ACULAR LS OPHTHALMIC SOLUTION 11/5/2009 6 KETOROLAC TROMETHAMINE OPHTHALMIC SOLUTION, 0.5% SUN PHARMA GLOBAL, INC. ACULAR OPHTHALMIC SOLUTION 11/5/2009 7 NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL TABLETS USP, 1 MG/0.005 MG BARR LABORATORIES, INC. FEMHRT TABLETS 1 MG/0.005 MG 11/6/2009 8 LANSOPRAZOLE DELAYED-RELEASE CAPSULES USP, 15 MG AND 30 MG TEVA PHARMACEUTICALS USA PREVACID DELAYED-RELEASE CAPSULES 11/10/2009 9 PERINDOPRIL ERBUMINE TABLETS, 2 MG, 4 MG AND 8 MG AUROBINDO PHARMA LIMITED ACEON TABLETS 11/10/2009 10 PERINDOPRIL ERBUMINE TABLETS, 2 MG, 4 MG AND 8 MG ROXANE LABORATORIES, INC. ACEON TABLETS 11/10/2009 11 LANSOPRAZOLE DELAYED-RELEASE CAPSULES USP, 15 MG AND 30 MG MATRIX LABORATORIES LIMITED PREVACID DELAYED-RELEASE CAPSULES 11/10/2009 12 PERINDOPRIL ERBUMINE TABLETS, 2 MG, 4 MG AND 8 MG IVAX PHARMACEUTICALS, INC. ACEON TABLETS 11/10/2009 13 TRAMADOL HYDROCHLORIDE EXTENDED-RELEASE TABLETS, 100 MG AND 200 MG PAR PHARMACEUTICAL, INC. ULTRAM ER TABLETS, 100 MG AND 200 MG 11/13/2009 14 NICARDIPINE HYDROCHLORIDE INJECTION, 2.5 MG/ML; PACKAGED IN 25 MG/10 ML SINGLE-DISE VIALS GENERAMEDIX, INC. CARDENE I.V. INJECTION 11/17/2009 15 NICARDIPINE HYDROCHLORIDE INJECTION, 2.5 MG/ML; PACKAGED IN 25 MG/10 ML SINGLE-USE VIALS PHARMAFORCE, INC. CARDENE I.V. INJECTION 11/17/2009 16 NICARDIPINE HYDROCHLORIDE INJECTION, 2.5 MG/ML; PACKAGED IN 25 MG/10 ML SINGLE-USE VIALS NAVINTA, LLC CARDENE I.V. INJECTION 11/17/2009 17 NICARDIPINE HYDROCHLORIDE INJECTION, 2.5 MG/ML, PACKAGED IN 25 MG/10 ML SINGLE-USE AMPULS SUN PHARMA GLOBAL, INC. CARDENE I.V. INJECTION 11/17/2009 18 NICARDIPINE HYDROCHLORIDE INJECTION, 2.5 MG/ML; PACKAGED IN 25 MG/10 ML SINGLE-USE VIALS WOCKHARDT LIMITED CARDENE I.V. INJECTION 11/17/2009 19 NIZATIDINE ORAL SOLUTION, 15 MG/ML AMNEAL PHARMACEUTICALS AXID ORAL SOLUTION 11/18/2009 First-Time Generics - October 2009 Generic Drug Name Generic Manufacturer Brand Name Approval Date 1 POLYETHYLENE GLYCOL 3350 POWDER FOR SOLUTION, (OTC), 17 GRAMS/ SCOOPFUL KREMERS URBAN DEVELOPMENT COMPANY MIRALAX FOR ORAL SOLUTION 10/6/2009 2 POLYETHYLENE GLYCOL 3350 POWDER FOR SOLUTION, (OTC), 17 GRAMS/ SCOOPFUL PERRIGO R&D COMPANY MIRALAX POWDER FOR SOLUTION 10/6/2009 3 POLYETHYLENE GLYCOL 3350 POWDER FOR SOLUTION, (OTC), 17 GRAMS/ SCOOPFUL NOVEL LABORATORIES, INC. MIRALAX POWDER FOR SOLUTION 10/6/2009 4 POLYETHYLENE GLYCOL 3350 POWDER FOR SOLUTION, (OTC), 17 GRAMS/SCOOPFUL OR SINGLE-DOSE POUCH MYLAN PHARMACEUTICALS, INC. MIRALAX POWDER FOR SOLUTION 10/6/2009 5 CLONIDINE HYDROCHLORIDE INJECTION, 0.1 MG/ML AND 0.5 MG/ML PHARMAFORCE, INC. DURACLON INJECTION 10/8/2009 6 BUPRENORPHINE HYDROCHLORIDE SUBLINGUAL TABLETS, 2 MG (BASE) AND 8 MG (BASE) ROXANE LABORATORIES, INC. SUBUTEX SUBLINGUAL TABLETS 10/8/2009 7 CHLOROTHIAZIDE SODIUM FOR INJECTION USP, 500 MG/VIAL APP PHARMACEUTICALS, INC. DIURIL INJECTION, 500 MG/VIAL 10/16/2009 8 CHENODIOL TABLETS, 250 MG NEXGEN PHARMA, INC. CHENIX TABLETS, 250 MG 10/22/2009 9 ORAL TRANSMUCOSAL FENTANYL CITRATE, 200 MCG, 400 MCG, 600 MCG, 800 MCG, 1200 MCG AND 1600 MCH BARR LABORATORIES, INC. ACTIQ 10/30/2009 10 ORAL TRANSMUCOSAL FENTANYL CITRATE, 200 MCG, 400 MCG, 600 MCG, 800 MCG, 1200 MCG AND 1600 MCG MALLINCKRODT INC. ACTIQ ORAL TRANSMUCOSAL LOZENGE 10/30/2009 First-Time Generics - October 2009 Generic Drug Name Generic Manufacturer Brand Name Approval Date 1 POLYETHYLENE GLYCOL 3350 POWDER FOR SOLUTION, (OTC), 17 GRAMS/ SCOOPFUL KREMERS URBAN DEVELOPMENT COMPANY MIRALAX FOR ORAL SOLUTION 10/6/2009 2 POLYETHYLENE GLYCOL 3350 POWDER FOR SOLUTION, (OTC), 17 GRAMS/ SCOOPFUL PERRIGO R&D COMPANY MIRALAX POWDER FOR SOLUTION 10/6/2009 3 POLYETHYLENE GLYCOL 3350 POWDER FOR SOLUTION, (OTC), 17 GRAMS/ SCOOPFUL NOVEL LABORATORIES, INC. MIRALAX POWDER FOR SOLUTION 10/6/2009 4 POLYETHYLENE GLYCOL 3350 POWDER FOR SOLUTION, (OTC), 17 GRAMS/SCOOPFUL OR SINGLE-DOSE POUCH MYLAN PHARMACEUTICALS, INC. MIRALAX POWDER FOR SOLUTION 10/6/2009 5 CLONIDINE HYDROCHLORIDE INJECTION, 0.1 MG/ML AND 0.5 MG/ML PHARMAFORCE, INC. DURACLON INJECTION 10/8/2009 6 BUPRENORPHINE HYDROCHLORIDE SUBLINGUAL TABLETS, 2 MG (BASE) AND 8 MG (BASE) ROXANE LABORATORIES, INC. SUBUTEX SUBLINGUAL TABLETS 10/8/2009 7 CHLOROTHIAZIDE SODIUM FOR INJECTION USP, 500 MG/VIAL APP PHARMACEUTICALS, INC. DIURIL INJECTION, 500 MG/VIAL 10/16/2009 8 CHENODIOL TABLETS, 250 MG NEXGEN PHARMA, INC. CHENIX TABLETS, 250 MG 10/22/2009 9 ORAL TRANSMUCOSAL FENTANYL CITRATE, 200 MCG, 400 MCG, 600 MCG, 800 MCG, 1200 MCG AND 1600 MCH BARR LABORATORIES, INC. ACTIQ 10/30/2009 10 ORAL TRANSMUCOSAL FENTANYL CITRATE, 200 MCG, 400 MCG, 600 MCG, 800 MCG, 1200 MCG AND 1600 MCG MALLINCKRODT INC. ACTIQ ORAL TRANSMUCOSAL LOZENGE 10/30/2009 First-Time Generics - September 2009 Generic Drug Name Generic Manufacturer Brand Name Approval Date 1 NORETHINDRONE ACETATE & ETHINYL ESTRADIOL TABLETS USP, & FE 1 MG/0.02 MG WITH 75 MG FERROUS FUMARATE (24-DAY REGIMEN) WATSON LABORATOTRIES, INC. LOESTRIN 24 FE TABLETS 9/1/2009 2 TEMAZEPAM CAPSULES USP, 7.5 MG MUTUAL PHARMACEUTICAL COMPANY, INC. RESTORIL CAPSULES 9/8/2009 3 NATEGLINIDE TABLETS, 60 MG AND 120 MG PAR PHARMACEUTICAL, INC. STARLIX TABLETS 9/9/2009 4 NATEGLINIDE TABLETS, 60 MG AND 120 MG DR. REDDY'S LABORATORIES, LIMITED STARLIX TABLETS 9/9/2009 5 NATEGLINIDE TABLETS, 60 MG AND 120 MG TEVA PHARMACEUTICALS USA STARLIX TABLETS 9/9/2009 6 PIPERACILLIN AND TAZOBACTAM FOR INJECTION, 36 G (BASE)/4.5 G (BASE)/VIAL, (PHARMACY BULK PACKAGE) ORCHID HEALTHCARE ZOSYN FOR INJECTION (PHARMACY BULK PACKAGE) 9/15/2009 7 PIPERACILLIN AND TAZOBACTAM FOR INJECTION, 2 G (BASE)/250 MG (BASE)/VIAL, 3 G (BASE)/375 MG (BASE)/VIAL AND 4 G (BASE)/500 MG (BASE)/VIAL ORCHID HEALTHCARE ZOSYN FOR INJECTION 9/15/2009 First-Time Generics - August 2009 Generic Drug Name Generic Manufacturer Brand Name Approval Date 1 AZELASTINE HYDROCHLORIDE OPHTHALMIC SOLUTION,0.05% APOTEX INC. OPTIVAR OPHTHALMIC SOLUTION 8/3/2009 2 OXALIPLATIN INJECTION,5 MG/ML; (PRESERVATIVE-FREE),PACKAGED IN 50 MG/10 ML AND100 MG/20 MLSINGLE-USE VIALS HOSPIRA WORLDWIDE PTY ELOXATIN INJECTION 8/7/2009 3 OXALIPLATIN FOR INJECTION,(PRESERVATIVE-FREE),PACKAGED IN 50 MG AND100 MG SINGLE-USE VIALS SUN PHARMA GLOBAL, FZE ELOXATIN FOR INJECTION 8/7/2009 4 OXALIPLATIN FOR INJECTION,50 MG AND100 MG(PRESERVATIVE-FREE)SINGLE-USE VIALS FRESENIUS KABI ONCOLOGY, PLC ELOXATIN FOR INJECTION 8/7/2009 5 TACROLIMUS CAPSULES0.5 MG,1 MG AND5 MG SANDOZ, INC. PROGRAF CAPSULES, 0.5 MG, 1 MG AND 5 MG 8/10/2009 6 CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE GEL1% (BASE)/5% DOW PHARMACEUTICAL SCIENCES, INC. BENZACLIN TOPICAL GEL 8/11/2009 7 ASPIRIN AND DIPYRIDAMOLE EXTENDED-RELEASE CAPSULES,25 MG/200 MG BARR LABORATORIES, INC. AGGRENOX EXTENDED-RELEASE CAPSULES 8/14/2009 8 CLONIDINE TRANSDERMAL SYSTEM, USP0.1 MG/DAY,0.2 MG/DAY AND0.3 MG/DAY AVEVA DRUG DELIVERY SYSTEMS, INC. CATAPRES-TTS 8/18/2009 9 LEVONORGESTREL TABLETS, (RX/OTC)0.75 MG WATSON LABORATORIES, INC. PLAN B TABLETS 8/28/2009 First-Time Generics - July 2009 Generic Drug Name Generic Manufacturer Brand Name Approval Date 1 BICALUTAMIDE TABLETS USP,50 MG MYLAN PHARMACEUTICALS, INC. CASODEX TABLETS 7/6/2009 2 BICALUTAMIDE TABLETS USP,50 MG ACCORD HEALTHCARE INC., USA CASODEX TABLETS 7/6/2009 3 BICALUTAMIDE TABLETS USP,50 MG SUN PHARMA GLOBAL, INC. CASODEX TABLETS 7/6/2009 4 BICALUTAMIDE TABLETS USP,50 MG ZYDUS PHARMACEUTICALS USA, INC. CASODEX TABLETS 7/6/2009 5 BICALUTAMIDE TABLETS USP,50 MG TEVA PHARMACEUTICALS USA CASODEX TABLETS 7/6/2009 6 BICALUTAMIDE TABLETS USP,50 MG SANDOZ INC. CASODEX TABLETS 7/6/2009 7 BICALUTAMIDE TABLETS USP,50 MG SYNTHON PHARMACEUTICALS, INC. CASODEX TABLETS 7/6/2009 8 BICALUTAMIDE TABLETS USP,50 MG KUDCO IRELAND, LTD. CASODEX TABLETS 7/6/2009 9 BENZTROPINE MESYLATE INJECTION USP,1 MG/ML NEXUS PHARMACEUTICALS INC. COGENTIN INJECTION, 1 MG/ML 7/28/2009 10 TRIAMCINOLONE ACETONIDE NASAL SPRAY0.055 MG/SPRAY BARR LABORATORIES, INC. NASACORT AQ NASAL SPRAY, 0.055 MG/SPRAY 7/30/2009 11 BETAMETHASONE ACETATE & BETAMETHASONE SODIUM PHOSPHATEINJECTABLE SUSPENSION USP,6 MG/ML(3 MG (BASE)/ML AND 3 MG/ML,RESPECTIVELY) PHARMAFORCE, INC. CELESTONE SOLUSPAN INJECTABLE SUSPENSION 7/31/2009 First-Time Generics - June 2009 Generic Drug Name Generic Manufacturer Brand Name Approval Date 1 TRIAMCINOLONE ACETONIDE INJECTABLE SUSPENSION USP, 40 MG/ML; PACKAGED IN 40 MG/1 ML VIALS AND 200 MG/5 ML AND 400 MG/10 ML MULTIPLE-DOSE VIALS SANDOZ CANADA INC. KENALOG-40 INJECTABLE SUSPENSION 6/1/2009 2 OMEPRAZOLE MAGNESIUM DELAYED-RELEASE CAPSULES, (OTC) 20 MG (BASE) DR. REDDY'S LABORATORIES LIMITED PRILOSEC OTC DELAYED-RELEASE CAPSULES 6/5/2009 3 MELPHALAN HYDROCHLORIDE FOR INJECTION, 50 MG (BASE)/VIAL SYNERX PHARMA, LLC ALKERAN FOR INJECTION 6/9/2009 4 LEVONORGESTREL TABLETS (Rx) 0.75 MG WATSON LABORATORIES, INC. PLAN B (LEVONORGESTREL) TABLETS, 0.75 MG 6/24/2009 5 OXCARBAZEPINE ORAL SUSPENSION, 300 MG/5 ML RANBAXY LABORATORIES LIMITED TRILEPTAL ORAL SUSPENSION 6/26/2009 6 NORGESTIMATE AND ETHINYL ESTRADIOL TABLETS USP, 0.180 MG/0.025 MG; 0.215 MG/0.025 MG AND 0.250 MG/0.025 MG (28-DAY REGIMEN) BARR LABORATORIES, INC. ORTHO TRI CYCLIN LO 6/29/2009 First-Time Generics - May 2009 Generic Drug Name Generic Manufacturer Brand Name Approval Date 1 TRIAMCINOLONE ACETONIDE INJECTABLE SUSPENSION USP, 10 MG/ML; PACKAGED IN 50 MG/5 ML MULTIPLE-DOSE VIALS SANDOZ CANADA, INC. KENALOG-10 INJECTABLE SUSPENSION 5/27/2 First-Time Generics - April 2009 Generic Drug Name Generic Manufacturer Brand Name Approval Date 1 TOPIRAMATE CAPSULES (SPRINKLE), 15 MG AND 25 MG BARR LABORATORIES, INC. TOPAMAX SPRINKLE CAPSULES 4/15/2009 2 TOPIRAMATE CAPSULES (SPRINKLE), 15 MG AND 25 MG COBALT LABORATORIES, INC. TOPAMAX SPRINKLE CAPSULES 4/15/2009 3 LORAZEPAM ORAL CONCENTRATE, USP 2 MG/ML PADDOCK LABORATORIES, INC. INTENSOL 4/28/2009 4 AZELASTINE HYDROCHLORIDE NASAL SOLUTION (NASAL SPRAY), 0.1% [125 MCG (BASE)/SPRAY] APOTEX INC. ASTELIN NASAL SPRAY 4/30/2009 5 MIVACURIUM CHLORIDE INJECTION, 2 MG (BASE)/ML; PACKAGED IN 10 MG (BASE)/5 ML AND 20 MG (BASE)/10 ML SINGLE-DOSE VIALS EBEWE PARENTA PHARMACEUTICALS, INC. MIVACRON INJECTION 4/30/2009 6 RISPERIDONE ORALLY DISINTEGRATING TABLETS, 0.25 MG, 0.5 MG, 2 MG, 3 MG AND 4 MG KALI LABORATORIES, INC. RISPERDAL-M TAB (ORALLY DISINTEGRATING TABLET 4/30/2009 |
2楼2010-04-01 09:02:20
FDA ANDA list 2009续
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First-Time Generics - March 2009 Generic Drug Name Generic Manufacturer Brand Name Approval Date 1 MALATHION LOTION, USP 0.5% SYNERX PHARMA, LLC OVIDE LOTION, 0.5% 3/6/2009 2 APRACLONIDINE OPHTHALMIC SOLUTION, USP 0.5% (BASE) AKORN, INC. IOPIDINE OPHTHALMIC SOLUTION, 0.5% 3/12/2009 3 LIOTHYRONINE SODIUM TABLETS, USP 5 MCG, 25 MCG, AND 50 MCG COASTAL PHARMACEUTICALS CYTOMEL TABLETS 3/20/2009 4 LEVALBUTEROL INHALATION SOLUTION USP, (CONCENTRATE) 0.25% (1.25 MG/0.5ML) DEY LP XOPENEX INHALATION SOLUTION (CONCENTRATE) 3/20/2009 5 IBUPROFEN CAPSULES, 200 MG (LIQUID FILLED CAPSULE) (OTC) BANNER PHARMACAPS, INC. ADVIL LIQUI-GELS CAPSULES 3/24/2009 6 TOPIRAMATE TABLETS, 25 MG, 50 MG, 100 MG AND 200 MG TEVA PHARMACEUTICALS USA TOPAMAX TABLETS 3/27/2009 7 TOPIRAMATE TABLETS, 25 MG, 50 MG, 100 MG AND 200 MG ZYDUS PHARMACEUTICALS USA, INC. TOPAMAX TABLETS 3/27/2009 8 TOPIRAMATE TABLETS, 25 MG, 50 MG AND 100 MG UNICHEM LABORATORIES LIMITED TOPAMAX TABLETS 3/27/2009 9 TOPIRAMATE TABLETS, 25 MG, 50 MG, 100 MG AND 200 MG AUROBINDO PHARMA LIMITED TOPAMAX TABLETS 3/27/2009 10 TOPIRAMATE TABLETS, 25 MG, 50 MG, 100 MG AND 200 MG INVAGEN PHARMACEUTICALS, INC TOPAMAX TABLETS 3/27/2009 11 TOPIRAMATE TABLETS, 25 MG, 50 MG, 100 MG AND 200 MG SUN PHARMACEUTICAL INDUSTRIES, LTD. TOPAMAX TABLETS 3/27/2009 12 TOPIRAMATE TABLETS, 25 MG, 100 MG AND 200 MG BARR LABORATORIES, INC. TOPAMAX TABLETS 3/27/2009 13 TOPIRAMATE TABLETS, 25 MG, 50 MG, 100 MG AND 200 MG ROXANE LABORATORIES, INC. TOPAMAX TABLETS 3/27/2009 14 TOPIRAMATE TABLETS, 25 MG, 50 MG, 100 MG AND 200 MG GLENMARK GENERICS LIMITED TOPAMAX TABLETS 3/27/2009 15 TOPIRAMATE TABLETS, 25 MG, 50 MG, 100 MG AND 200 MG COBALT LABORATORIES TOPAMAX TABLETS 3/27/2009 16 TOPIRAMATE TABLETS, 25 MG, 50 MG, 100 MG AND 200 MG APOTEX INC. TOPAMAX TABLETS 3/27/2009 17 TOPIRAMATE TABLETS, 25 MG, 50 MG, 100 MG AND 200 MG MYLAN PHARMACEUTICALS INC. TOPAMAX TABLETS 3/27/2009 18 TOPIRAMATE TABLETS, 25 MG, 50 MG, 100 MG AND 200 MG CIPLA LIMITED TOPAMAX TABLETS 3/27/2009 19 TOPIRAMATE TABLETS, 25 MG, 50 MG, 100 MG AND 200 MG PAR PHARMACEUTICAL, INC TOPAMAX TABLETS 3/27/2009 20 TOPIRAMATE TABLETS, 25 MG, 100 MG AND 200 MG RANBAXY LABLRATORIES LIMITED TOPAMAX TABLETS 3/27/2009 21 TOPIRAMATE TABLETS, 25 MG, 50 MG, 100 MG AND 200 MG TORRENT PHARMACEUTICALS LIMITED TOPAMAX TABLETS 3/27/2009 22 DROSPIRENONE AND ETHINYL ESTRADIOL TABLETS, 3 MG/0.02 MG (28-DAY REGIMEN) BARR LABORATORIES, INC. YAZ TABLETS 3/30/2009 23 CARBAMAZEPINE EXTENDED-RELEASE TABLETS USP, 100 MG, 200 MG AND 400 MG TARO PHARMACEUTICALS USA, INC. TEGRETOL-XR TABLETS 3/31/2009 First-Time Generics - February 2009 Generic Drug Name Generic Manufacturer Brand Name Approval Date 1 MINOCYCLINE HYDROCHLORIDE EXTENDED-RELEASE TABLETS, 45 MG (BASE), 90 MG (BASE) AND 135 MG (BASE) IMPAX LABORATORIES, INC. SOLODYN TABLETS 2/3/2009 2 SUMATRIPTAN SUCCINATE INJECTION, 4 MG (BASE)/0.5 ML AND 6 MG (BASE)/0.5 ML; SINGLE-DOSE VIALS SANDOZ CANADA, INC. IMITREX INJECTION, SINGLE DOSE VIALS 2/6/2009 3 SUMATRIPTAN SUCCINATE INJECTION, 6 MG (BASE)/0.5 ML; SINGLE-DOSE VIALS BEDFORD LABORATORIES IMITREX INJECTION, 6 MG (BASE)/0.5 ML 2/6/2009 4 SUMATRIPTAN SUCCINATE INJECTION, 6 MG (BASE)/0.5 ML; SINGLE-DOSE VIALS TEVA PARENTERAL MEDICINES IMITREX INJECTION, 6 MG (BASE)/0.5 ML 2/6/2009 5 SUMATRIPTAN SUCCINATE INJECTION (SYRINGE), 4 MG (BASE)/0.5 ML AND 6 MG (BASE)/0.5 ML; PRE-FILLED SYRINGES TEVA PARENTERAL MEDICINES IMITREX INJECTION, 8 MG/ML, 12 MG/ML SYRINGE 2/6/2009 6 SUMATRIPTAN SUCCINATE TABLETS, 25 MG (BASE), 50 MG (BASE) AND 100 MG (BASE) TEVA PHARMACEUTICALS USA IMITREX TABLETS 2/9/2009 7 SUMATRIPTAN SUCCINATE TABLETS, 100 MG RANBAXY LABORATORIES LIMITED IMITREX TABLETS 2/9/2009 8 RISPERIDONE ORALLY DISINTEGRATING TABLETS, 0.5 MG AND 2 MG DR. REDDY'S LABORATORIES LIMITED RISPERDAL M-TAB (ORALLY DISINTEGRATING TABLET 2/24/2009 First-Time Generics - January 2009 Generic Drug Name Generic Manufacturer Brand Name Approval Date 1 ALPRAZOLAM ORALLY DISINTEGRATING TABLETS, 0.25 MG, 0.5 MG, 1 MG AND 2 MG KALI LABORATORIES, INC. NIRAVAM ORALLY DISINTEGRATING TABLETS 1/9/2009 2 LEVETIRACETAM ORAL SOLUTION, 100 MG/ML ACTAVIS MID ATLANTIC LLC KEPPRA ORAL SOLUTION 1/15/2009 3 LEVETIRACETAM ORAL SOLUTION, 100 MG/ML AUROBINDO PHARMA LTD KEPPRA ORAL SOLUTION, 100 MG/ML 1/15/2009 4 LEVETIRACETAM ORAL SOLUTION, 100 MG/ML TOLMAR INC. KEPPRA ORAL SOLUTION 1/15/2009 5 LEVETIRACETAM ORAL SOLUTION, 100 MG/ML ROXANE LABORATORIES, INC. KEPPRA ORAL SOLUTION 1/15/2009 6 DIVALPROEX SODIUM DELAYED RELEASE CAPSULES (SPRINKLE), 125 MG (VALPROIC ACID EQUIVALENT) DR. REDDY'S LABORATORIES, INC. DEPAKOTE SPRINKLE CAPSULES, 125 MG 1/23/2009 7 DIVALPROEX SODIUM EXTENDED-RELEASE TABLETS, 250 MG AND 500 MG MYLAN PHARMACEUTICALS, INC. DEPAKOTE ER TABLETS, 250 MG AND 500 MG 1/29/2009 8 RISPERIDONE ORAL SOLUTION, 1 MG/ML TEVA PHARMACEUTICALS USA RISPERDAL ORAL SOLUTION 1/30/2009 9 GALANTAMINE HYDROBROMIDE ORAL SOLUTION, 4 MG/ML ROXANE LABORATORIES, INC. RAZADYNE ORAL SOLUTION 1/30/2009 |
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