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U.S. Department of Health and Human Services

Drugs

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Approvals - March 2004

 ANDA NumberGeneric Drug NameApplicantApproval Date
176-833METOLAZONE TABLETS, USP 5 MG  TEVA PHARMACEUTICALS USA3/1/2004 
275-006CHLORHEXIDINE GLUCONATE ORAL RINSE, USP 0.12%  MORTON GROVE PHARMACEUTICALS, INC.3/3/2004 
375-989LORATADINE AND PSEUDOEPHEDRINE SULFATE EXTENDED-RELEASE TABL 10 MG/240 MG (24-HOUR FORMULATION) (OTC)  IMPAX LABORATORIES, INC.3/4/2004 
475-716PAROXETINE HYDROCHLORIDE TABLETS 10 MG (BASE), 20 MG (BASE), 30 MG (BASE), AND 40 MG (BASE)  ALPHAPHARM PTY. LTD.3/8/2004 
575-566PAROXETINE HYDROCHLORIDE TABLETS 10 MG (BASE), 20 MG (BASE), 30 MG (BASE) AND 40 MG (BASE)  SANDOZ INC.3/8/2004 
640-521PHENYTOIN ORAL SUSPENSION, USP 125 MG/5 ML  TARO PHARMACEUTICAL INDUSTRIES LTD.3/8/2004 
776-168OXYCODONE HYDROCHLORIDE EXTENDED-RELEASE TABLETS 80 MG  TEVA PHARMACEUTICALS USA3/23/2004 
865-162AMOXICILLIN & CLAVULANATE POTASSIUM FOR ORAL SUSPENSION, US 600 MG/42.9 MG (BASE)/5 ML  TEVA PHARMACEUTICALS USA3/12/2004 
940-503HYDROCORTISONE CREAM, USP 2.5%  VINTAGE PHARMACEUTICALS, LLC3/12/2004 
1076-518NAPROXEN SODIUM & PSEUDOEPHEDRINE HCL EXTENDED-RELEASE TABLE 200 MG (BASE)/120 MG  L. PERRIGO COMPANY3/17/2004 
1176-019DEFEROXAMINE MESYLATE FOR INJECTION, USP 500 MG/VIAL AND 2 G/VIAL  ABBOTT LABORATORIES3/17/2004 
1240-524PROMETHAZINE HYDROCHLORIDE INJECTION, USP 25 MG/ML AND 50 MG/ML PACKAGED IN 1 ML AMPULES  BEDFORD LABORATORIES3/17/2004 
1376-561DICLOFENAC POTASSIUM TABLETS 50 MG  TORPHARM, INC.3/18/2004 
1476-642HYDROCODONE BITARTRATE AND IBUPROFEN TABLETS 5 MG/200 MG  INTERPHARM, INC.3/18/2004 
1575-923OXYCODONE HYDROCHLORIDE EXTENDED-RELEASE TABLETS 10 MG, 20 MG, AND 40 MG  ENDO PHARMACEUTICALS, INC.3/23/2004 
1665-177COLISTIMETHATE FOR INJECTION, USP 150 MG (BASE)/VIAL  PADDOCK LABORATORIES, INC.3/19/2004 
1765-194CLINDAMYCIN HYDROCHLORIDE CAPSULES, USP 150 MG (BASE), AND 300 MG (BASE)  COREPHARMA LLC3/22/2004 
1876-648NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS) CAPSULES 100 MG  MYLAN PHARMACEUTICALS, INC.3/22/2004 
1965-094DEMECLOCYCLINE HYDROCHLORIDE TABLETS, USP 150 MG AND 300 MG  IMPAX LABORATORIES, INC.3/22/2004 
2075-414NIFEDIPINE EXTENDED-RELEASE TABLETS, USP 90 MG  MARTEC SCIENTIFIC, INC.3/23/2004 
2176-335NORGESTIMATE AND ETHINYL ESTRADIOL TABLETS 0.18 MG/0.035 MG, 0.215 MG/0.035 MG, AND 0.25 MG/0.035 MG PACKAGED AS A TRIPHASIC REGIMEN (28-DAY CYCLE)  ANDRX PHARMACEUTICALS, LLC3/26/2004 
2276-796FUROSEMIDE TABLETS, USP 20 MG, 40 MG, AND 80 MG  VINTAGE PHARMACEUTICALS, LLC3/26/2004 
2376-585MICONAZOLE NITRATE SUPPOSITORIES & MICONAZOLE NITRATE CREAM 100 MG/2% (COMBINATION PACKAGE) (OTC)  G & W LABORATORIES, INC.3/26/2004 
2465-112ERYTHROMYCIN AND BENZOYL PEROXIDE TOPICAL GEL, USP 3%/5%  ATRIX LABORATORIES, INC.3/29/2004 
2576-357MICONAZOLE NITRATE CREAM 4% & MICONAZOLE NITRATE CREAM 2% 4%/2% (COMBINATION PACKAGE) (OTC)  L. PERRIGO COMPANY3/30/2004 
2676-374QUINAPRIL HYDROCHLORIDE & HYDROCHLOROTHIAZIDE TABLETS 10 MG (BASE)/12.5 MG, 20 MG (BASE)/12.5 MG, AND 20 MG (BASE)/25 MG  AMIDE PHARMACEUTICAL, INC.3/31/2004 
2765-184CLINDAMYCIN PHOSPHATE TOPICAL SOLUTION, USP 1% (BASE)  TARO PHARMACEUTICAL INDUSTRIES LTD.3/31/2004