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U.S. Department of Health and Human Services

Drugs

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Approvals - September 2003

 ANDA NumberGeneric Drug NameApplicantApproval Date
176-220OFLOXACIN TABLETS 200 MG, 300 MG, AND 400 MG  RANBAXY LABORATORIES LIMITED9/2/2003 
276-093OFLOXACIN TABLETS 200 MG, 300 MG, AND 400 MG  PAR PHARMACEUTICAL, INC.9/2/2003 
376-182OFLOXACIN TABLETS 200 MG, 300 MG, AND 400 MG  TEVA PHARMACEUTICALS USA9/2/2003 
475-958MIDAZOLAM HYDROCHLORIDE SYRUP 2 MG (BASE)/ML  HI-TECH PHARMACAL CO., INC.9/4/2003 
576-094PERGOLIDE MESYLATE TABLETS, USP 0.05 MG (BASE), 0.25 MG (BASE), AND 1 MG (BASE)  IVAX PHARMACEUTICALS S.R.O.9/4/2003 
676-163AMIODARONE HYDROCHLORIDE INJECTION 50 MG/ML; PACKAGED IN 150 MG/3 ML, 450 MG/9 ML, AND 900 MG/18 ML SINGLE-USE VIALS  SICOR PHARMACEUTICALS, INC.9/5/2003 
740-535OXYCODONE AND ACETAMINOPHEN TABLETS, USP 7.5 MG/325 MG AND 10 MG/325 MG  WATSON LABORATORIES, INC.9/5/2003 
876-514MIDODRINE HYDROCHLORIDE TABLETS 2.5 MG AND 5 MG  EON LABS, INC.9/11/2003 
976-467GLIPIZIDE EXTENDED-RELEASE TABLETS 5 MG  WATSON LABORATORIES, INC.9/8/2003 
1040-480AMPHETAMINE AND DEXTROAMPHETAMINE TABLETS (MIXED SALTS) 5 MG, 7.5 MG, 10 MG, 12.5 MG, 15 MG, 20 MG, AND 30 MG  MUTUAL PHARMACEUTICAL COMPANY, INC.9/9/2003 
1140-313PREDNISOLONE SYRUP, USP 15 MG/5 ML  MORTON GROVE PHARMACEUTICALS, INC.9/10/2003 
1276-429PROPOXYPHENE NAPSYLATE AND ACETAMINOPHEN TABLETS, USP 100 MG/500 MG  AAI PHARMA9/10/2003 
1376-577MIDODRINE HYDROCHLORIDE TABLETS 2.5 MG, 5 MG, AND 10 MG  MYLAN PHARMACEUTICALS, INC.9/10/2003 
1476-254BRIMONIDINE TARTRATE OPHTHALMIC SOLUTION 0.2%  ALCON INC.9/16/2003 
1576-302NEFAZODONE HYDROCHLORIDE TABLETS 50 MG, 100 MG, 150 MG, 200 MG, AND 250 MG  EON LABS, INC.9/16/2003 
1665-100CEPHALEXIN TABLETS FOR ORAL SUSPENSION 125 MG AND 250 MG  RANBAXY LABORATORIES LIMITED9/11/2003 
1775-350GABAPENTIN CAPSULES 100 MG, 300 MG, AND 400 MG  PUREPAC PHARMACEUTICAL CO.9/12/2003 
1875-145SELEGILINE HYDROCHLORIDE CAPSULES 5 MG  AAI PHARMA9/15/2003 
1975-763NEFAZODONE HYDROCHLORIDE TABLETS 50 MG, 100 MG, 150 MG, 200 MG, AND 250 MG  IVAX PHARMACEUTICALS, INC.9/16/2003 
2076-072NEFAZODONE HYDROCHLORIDE TABLETS 50 MG, 100 MG, 150 MG, 200 MG, AND 250 MG  GENEVA PHARMACEUTICALS, INC.9/16/2003 
2176-409NEFAZODONE HYDROCHLORIDE TABLETS 50 MG, 100 MG, 150 MG, 200 MG, AND 250 MG  RANBAXY LABORATORIES LIMITED9/16/2003 
2276-037NEFAZODONE HYDROCHLORIDE TABLETS 50 MG, 100 MG, 150 MG, 200 MG, AND 250 MG  TEVA PHARMACEUTICALS USA9/16/2003 
2376-309NEFAZODONE HYDROCHLORIDE TABLETS 50 MG, 100 MG, 150 MG, 200 MG, AND 250 MG  DR. REDDY'S LABORATORIES LIMITED9/16/2003 
2476-196NEFAZODONE HYDROCHLORIDE TABLETS 50 MG, 100 MG, 150 MG, 200 MG, AND 250 MG  ROXANE LABORATORIES, INC.9/16/2003 
2576-129NEFAZODONE HYDROCHLORIDE TABLETS 100 MG, 150 MG, 200 MG, AND 250 MG  MYLAN PHARMACEUTICALS, INC.9/16/2003 
2676-073NEFAZODONE HYDROCHLORIDE TABLETS 100 MG, 150 MG, 200 MG, AND 250 MG  WATSON LABORATORIES, INC.9/16/2003 
2776-206CALCITRIOL INJECTION 0.001 MG/ML (1 MCG/ML)  LYNE LABORATORIES, INC.9/17/2003 
2876-064NORETHINDRONE ACETATE & ETHINYL ESTRADIOL TABLETS, USP & F 1.5 MG/30 MCG (WITH FERROUS FUMARATE, 75 MG)  BARR LABORATORIES, INC.9/18/2003 
2976-081NORETHINDRONE ACETATE & ETHINYL ESTRADIOL TABLETS, USP & FER 1 MG/20 MCG (AND FERROUS FUMARATE, 75 MG)  BARR LABORATORIES, INC.9/18/2003 
3040-451CYANOCOBALAMIN INJECTION, USP 1,000 MCG/ML (1 MG/ML) PACKAGED IN 10 ML MULTIPLE-DOSE VIALS.  PHARMAFORCE, INC.9/23/2003 
3165-124CEFOTAXIME FOR INJECTION, USP 500 MG, 1 G, AND 2 G/VIAL  LUPIN LIMITED9/24/2003 
3240-482HYDROCODONE BITARTRATE AND ACETAMINOPHEN ORAL SOLUTION 7.5 MG/325 MG PER 15 ML  MIKART INC.9/25/2003 
3376-290LIDOCAINE AND PRILOCAINE CREAM 2.5%/2.5%  HI-TECH PHARMACAL CO., INC.9/25/2003 
3475-746CALCITRIOL INJECTION 0.001 MG/ML (1 MCG/ML) AND 0.002 MG/ML (2 MCG/ML) PACKAGED IN 1 ML SINGLE-USE AMPULES  LUITPOLD PHARMACEUTICALS, INC.9/26/2003 
3576-525CARBAMAZEPINE TABLETS, USP 200 MG  TARO PHARMACEUTICAL INDUSTRIES, LTD.9/26/2003 
3676-011LORATADINE ORALLY DISINTEGRATING TABLETS (OTC) 10 MG  IMPAX LABORATORIES, INC.9/29/2003 
3765-125CEFTRIAXONE FOR INJECTION, USP 250 MG, 500 MG, 1 G, AND 2 G/SINGLE-USE VIAL  LUPIN LIMITED9/30/2003 
3840-472AMPHETAMINE AND DEXTROAMPHETAMINE TABLETS (MIXED SALTS) 5 MG, 10 MG, 20 MG, AND 30 MG  ABRIKA PHARMACEUTICALS, LLLP9/30/2003 
3940-537CYPROHEPTADINE HYDROCHLORIDE TABLETS, USP 4 MG  COREPHARMA LLC9/30/2003 
4076-416TIZANIDINE HYDROCHLORIDE TABLETS 2 MG (BASE) AND 4 MG (BASE)  CARACO PHARMACEUTICAL LABORATORIES, LTD.9/29/2003 
4140-518BETHANECHOL CHLORIDE TABLETS, USP 50 MG  WOCKHARDT LIMITED9/29/2003 
4240-532BETHANECHOL CHLORIDE TALBETS, USP 5 MG  WOCKHARDT LIMITED9/29/2003 
4340-534BETHANECHOL CHLORIDE TABLETS, USP 25 MG  WOCKHARDT LIMITED9/29/2003 
4440-533BETHANECHOL CHLORIDE TABLETS 10 MG  WOCKHARDT LIMITED9/29/2003