2009年FDA首次批准的仿制药

2009年一月
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. REDDYS 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

2009年2月
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. REDDYS LABORATORIES LIMITED RISPERDAL M-TAB (ORALLY DISINTEGRATING TABLET 2/24/2009 

2009年三月
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

2009年4月
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

2009年五月
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 5/27/2009

2009年六月
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. REDDYS 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

2009年七月
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

2009年八月
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

 
2009年9月
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. REDDYS 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 - 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

2009年11月

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 

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