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U.S. Department of Health and Human Services

Drugs

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Approvals - January 2004

 ANDA NumberGeneric Drug NameApplicantApproval Date
176-691LITHIUM CARBONATE EXTENDED-RELEASE TABLETS, USP 450 MG  ROXANE LABORATORIES, INC.1/5/2004 
276-600METOLAZONE TABLETS, USP 2.5 MG  TEVA PHARMACEUTICALS USA1/6/2004 
376-334NORGESTIMATE AND ETHINYL ESTRADIOL TABLETS 0.25 MG/0.035 MG  ANDRX PHARMACEUTICALS, LLC1/9/2004 
465-156MINOCYCLINE HYDROCHLORIDE TABLETS, USP 50 MG (BASE) 75 MG (BASE) 100 MG (BASE)  RANBAXY LABORATORIES LIMITED1/6/2004 
576-419KETOCONAZOLE SHAMPOO 2%  CLAY-PARK LABS, INC.1/7/2004 
640-538PREDNISONE TABLETS, USP 2.5 MG  WEST-WARD PHARMACEUTICAL CORP.1/8/2004 
765-046CEFUROXIME FOR INJECTION, USP 7.5 G/100 ML PHARMACY BULK PACKAGE  HIKMA FARMACEUTICA (PORTUGAL), LDA1/9/2004 
865-048CEFUROXIME FOR INJECTION, USP 750 MG/10 ML & 1.5 G/20 ML VIALS; AND 750 MG/100 ML & 1.5 G/100 ML INTRAVENOUS INFUSION VIALS  HIKMA FARMACEUTICA (PORTUGAL), LDA1/9/2004 
975-739MESNA INJECTION 100 MG/ML, PACKAGED IN 1G/10 ML MULTIPLE-DOSE VIALS  BEDFORD LABORATORIES1/9/2004 
1076-364HYDROCORTISONE BUTYRATE TOPICAL SOLUTION 0.1%  TARO PHARMACEUTICAL INDUSTRIES LTD.1/14/2004 
1176-494NAPROXEN TABLETS, USP 250 MG, 375 MG, AND 500 MG  WEST-WARD PHARMACEUTICAL CORP1/14/2004 
1275-924DOXEPIN HYDROCHLORIDE ORAL SOLUTION, USP (CONCENTRATE) 10 MG (BASE)/ML  PHARMACEUTICAL ASSOCIATES, INC.1/15/2004 
1376-512CYTARABINE INJECTION 100 MG/ML; PACKAGED IN 2 G/20 ML SINGLE-DOSE VIALS  AMERICAN PHARMACEUTICAL PARTNERS, INC.1/15/2004 
1476-670METOPROLOL TARTRATE TABLETS, USP 25 MG  CARACO PHARMACEUTICAL LABORATORIES, LTD.1/15/2004 
1576-533TIZANIDINE HYDROCHLORIDE TABLETS 2 MG (BASE), AND 4 MG (BASE)  TORPHARM, INC.1/16/2004 
1676-359IBUPROFEN CHEWABLE TABLETS 50 MG (ORANGE & GRAPE FLAVORED), AND 100 MG (ORANGE & GRAPE FLAVORED)  L. PERRIGO COMPANY1/16/2004 
1775-816CALCITRIOL INJECTION 0.001 MG/ML,AND 0.002 MG/ML PACKAGED IN 1 ML SINGLE-DOSE VIALS  MAYNE PHARMA (USA) INC.1/16/2004 
1876-704METOPROLOL TARTRATE TABLETS, USP 25 MG, 50 MG, AND 100 MG  MYLAN PHARMACEUTICALS, INC.1/16/2004 
1965-146CEFACLOR CAPSULES, USP 250 MG AND 500 MG  YUNG SHIN PHARMACEUTICAL INDUSTRIAL CO.1/22/2004 
2076-603BETAMETHASONE DIPROPIONATE CREAM, USP (AUGMENTED) 0.05% (BASE)  ATRIX LABORATORIES, INC.1/23/2004 
2175-913BUPROPION HYDROCHLORIDE EXTENDED-RELEASE TABLETS 100 MG  IMPAX LABORATORIES, INC.1/28/2004 
2276-208LORATADINE AND PSEUDOEPHEDRINE SULFATE EXTENDED-RELEASE TABS 5 MG/120 MG (12 HOUR FORMULATION)  ANDRX PHARMACEUTICALS, INC.1/28/2004 
2376-522METRONIDAZOLE CAPSULES 375 MG  KALI LABORATORIES, INC.1/29/2004 
2465-121GENTAMICIN SULFATE OPHTHALMIC SOLUTION, USP 0.3% (BASE)  ALTANA INC.1/30/2004