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U.S. Department of Health and Human Services

Drugs

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Approvals - September 2004

 ANDA NumberGeneric Drug NameApplicantApproval Date
175-987OXAPROZIN TABLETS, USP 600 MG  TORPHARM, INC.9/2/2004 
276-352AMANTADINE HYDROCHLORIDE SYRUP, USP 50 MG/ 5 ML  SILARX PHARMACEUTICALS, INC.9/10/2004 
376-372BRIMONIDINE TARTRATE OPHTHALMIC SOLUTION 0.2%  IVAX PHARMACEUTICALS, INC.9/10/2004 
476-639CIPROFLOXACIN TABLETS, USP 250 MG, 500 MG, AND 750 MG  UNIQUE PHARMACEUTICAL LABORATORIES9/10/2004 
576-865FLUTICASONE PROPIONATE CREAM 0.05%  KV PHARMACEUTICAL COMPANY9/10/2004 
676-775NICOTINE POLACRILEX GUM, USP (OTC) 2 MG (BASE) REGULAR FLAVOR  L. PERRIGO COMPANY9/16/2004 
776-776NICOTINE POLACRILEX GUM, USP (OTC) 2 MG (BASE) ORANGE FLAVOR  L. PERRIGO COMPANY9/16/2004 
876-777NICOTINE POLACRILEX GUM, USP (OTC) 2 MG (BASE) MINT FLAVOR  L. PERRIGO COMPANY9/16/2004 
976-778NICOTINE POLACRILEX GUM, USP (OTC) 4 MG (BASE) ORANGE FLAVOR  L. PERRIGO COMPANY9/16/2004 
1076-779NICOTINE POLACRILEX GUM, USP (OTC) 4 MG (BASE) MINT FLAVOR  L. PERRIGO COMPANY9/16/2004 
1176-789NICOTINE POLACRILEX GUM, USP (OTC) 4 MG (BASE) REGULAR FLAVOR  L. PERRIGO COMPANY9/16/2004 
1240-510ERGOTAMINE TARTRATE AND CAFFEINE TABLETS, USP 1 MG/100 MG  WEST-WARD PHARMACEUTICAL CORP.9/17/2004 
1365-133CYCLOSPORIN ORAL SOLUTION, USP 100 MG/ML  MORTON GROVE PHARMACEUTICALS, INC.9/17/2004 
1476-751MESALAMINE RECTAL SUSPENSION, USP (ENEMA) 4 G/60 ML  AGIS INDUSTRIES (1983), LTD.9/17/2004 
1576-729CARBAMAZEPINE ORAL SUSPENSION, USP 100 MG/5 ML  TARO PHARMACEUTICAL INDUSTRIES, LTD.9/20/2004 
1676-858LEVOCARNITINE TABLETS, USP 330 MG  COREPHARMA LLC9/20/2004 
1776-427MILRINONE LACTATE INJECTION 1 MG (BASE)/ML; PACKAGED IN 10 MG (BASE)/10 ML AND 20 MG (BASE)/20 ML SINGLE-DOSE VIALS  APOTEX CORP.9/21/2004 
1876-557LORATADINE AND PSEUDOEPHEDRINE SULFATE EXTENDED-RELEASE TABL 10 MG/240 MG (OTC) (24-HOUR FORMULATION)  RANBAXY LABORATORIES LIMITED9/22/2004 
1976-925IBUPROFEN ORAL SUSPENSION, USP 100 MG/5 ML  PERRIGO R & D COMPANY9/23/2004 
2065-174CLARITHROMYCIN TABLETS, USP 250 MG AND 500 MG  RANBAXY LABORATORIES LIMITED9/24/2004 
2165-206CLINDAMYCIN INJECTION, USP 150 MG/ML (PHARMACY BULK PACKAGE)  BEDFORD LABORATORIES9/24/2004 
2276-962BROMOCRIPTINE MESYLATE TABLETS, USP 2.5 MG (BASE)  MYLAN PHARMACEUTICALS, INC.9/24/2004 
2340-415WARFARIN SODIUM TABLETS, USP 1 MG, 2 MG, 2.5 MG, 3 MG, 4 MG, 5 MG, 6 MG, 7.5 MG, AND 10 MG  GENPHARM INC.9/27/2004 
2476-318OXYCODONE HYDROCHLORIDE EXTENDED-RELEASE TABLETS 80 MG  IMPAX LABORATORIES, INC.9/27/2004 
2576-068DEXRAZOXANE FOR INJECTION 250 MG AND 500 MG; PACKAGED IN SINGLE-DOSE VIALS  BEDFORD LABORATORIES9/28/2004 
2676-464HALOPERIDOL INJECTION, USP 5 MG/ML; PACKAGED IN 1 ML AMPULES  SABEX 2002 INC.9/29/2004 
2776-783NORETHINDRONE AND ETHINYL ESTRADIOL TABLETS, USP 0.5 MG/0.035 MG AND 1 MG/0.035 MG (28-DAY REGIMEN) (ARANELLE TABLETS)  BARR LABORATORIES, INC.9/29/2004 
2876-911CLORAZEPATE DIPOTASSIUM TABLETS, USP 3.75 MG, 7.5 MG, AND 15 MG  RANBAXY LABORATORIES LIMITED9/29/2004 
2940-522NOREPINEPHRINE BITARTRATE INJECTION, USP 1 MG (BASE)/ML; PACKAGED IN 4 MG (BASE)/4 ML AMPOULES  PHARMAFORCE, INC.9/30/2004 
3076-321TIZANIDINE HYDROCHLORIDE TABLETS 2 MG (BASE) AND 4 MG (BASE)  IVAX PHARMACEUTICALS, INC.9/30/2004 
3176-841MESALAMINE RECTAL SUSPENSION, USP (ENEMA) 4 G/60 ML  TEVA PHARMACEUTICALS USA9/30/2004