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U.S. Department of Health and Human Services

Drugs

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Approvals - May 2002

 ANDA NumberDrug NameApplicantApproval Date
165-036IDARUBICIN HYDROCHLORIDE INJECTION 1 MG/ML; (5 MG/5 ML, 10 MG/10 ML, AND 20 MG/20 ML SINGLE-DOSE VIALS)GENSIA SICOR PHARMACEUTICALS, INC.5/1/02
265-037IDARUBICIN HYDROCHLORIDE FOR INJECTION, USP 5 MG, 10 MG, AND 20 MG SINGLE-DOSE VIALSGENSIA SICOR PHARMACEUTICALS, INC.5/1/02
375-774AMMONIUM LACTATE CREAM 12% (BASE)CLAY-PARK LABS, INC.5/1/02
475-594PAMIDRONATE DISODIUM FOR INJECTION 30 MG/VIAL 90 MG/VIALAESGEN, INC.5/6/02
575-773PAMIDRONATE DISODIUM FOR INJECTION 30 MG/VIAL AND 90 MG/VIALAMERICAN PHARMACEUTICAL PARTNERS, INC.5/6/02
676-131PACLITAXEL INJECTION 6 MG/ML (PACKAGED IN 30 MG/5 ML, 100 MG/16.7 ML, AND 300 MG/50 ML MULTIPLE-DOSE VIALS)ABBOTT LABORATORIES5/8/02
765-040CYCLOSPORINE CAPSULES, USP 25 MG AND 100 MGTORPHARM5/9/02
875-388BUSPIRONE HYDROCHLORIDE TABLETS, USP 5 MG, 10 MG, AND 15 MGPHARMEX PRODUCTS, INC.5/9/02
975-846OXAPROZIN TABLETS 600 MGIVAX PHARMACEUTICALS, INC.5/13/02
1076-110TORSEMIDE TABLETS 5 MG, 10 MG, 20 MG, AND 100 MGTEVA PHARMACEUTICALS USA5/14/02
1176-207PAMIDRONATE DISODIUM INJECTION 3 MG/ML (PACKAGED IN 30 MG/10 ML SINGLE-USE VIALS), AND 9 MG/ML (PACKAGED IN 90 MG/10 ML SINGLE-USE VIALS)AMERICAN PHARMACEUTICAL PARTNERS, INC.5/17/02
1265-010NEOMYCIN SULFATE ORAL SOLUTION, USP 125 MG/5 MLPHARMA-TEK, INC.5/23/02
1375-866LEVONORGESTREL AND ETHINYL ESTRADIOL TABLETS, USP 0.15 MG/0.03 MG; PACKAGED IN 21-DAY (PORTIA-21) AND 28-DAY (PORTIA-28) CYCLESBARR LABORATORIES, INC.5/23/02
1440-466DIPHENHYDRAMINE HYDROCHLORIDE INJECTION, USP 50 MG/ML, (1 ML FILL IN 2 ML SINGLE- DOSE VIAL).AMERICAN PHARMACEUTICAL PARTNERS, INC.5/28/02
1575-510MILRINONE LACTATE IN 5% DEXTROSE INJECTION 0.2 MG (BASE)/ML; 100 ML SINGLE-DOSE VIAL FOR INFUSIONESI LEDERLE5/28/02
1675-530MILRINONE LACTATE INJECTION 1 MG (BASE)/ML; 10 MG (BASE)/10 ML & 20 MG (BASE)/20 ML SINGLE-DOSE VIALSESI LEDERLE5/28/02
1775-660MILRINONE LACTATE INJECTION 1 MG (BASE)/ML, PACKAGED IN 10 MG (BASE)/10 ML, 20 MG (BASE)/20 ML, AND 50 MG (BASE)/50 ML SINGLE-DOSE VIALSBEDFORD LABORATORIES5/28/02
1875-830MILRINONE LACTATE INJECTION 1 MG (BASE)/ML; PACKAGED IN 10 ML, 20 ML, AND 50 ML VIALSFAULDING PHARMACEUTICAL CO.5/28/02
1975-834MILRINONE LACTATE IN 5% DEXTROSE INJECTION 0.2 MG (BASE)/ML, PACKAGED IN 100 ML AND 200 ML SINGLE-DOSE PLASTIC CONTAINERS FOR INTRAVENOUS INFUSIONBAXTER HEALTHCARE CORPORATION5/28/02
2075-852MILRINONE LACTATE INJECTION 1 MG (BASE)/ML, PACKAGED IN 10 MG (BASE)/10 ML, 20 MG (BASE)/20 ML, AND 50 MG (BASE)/50 ML SINGLE-DOSE VIALSBAXTER HEALTHCARE CORPORATION5/28/02
2175-884MILRINONE LACTATE INJECTION 1 MG (BASE)/ML, PACKAGED IN 10 MG (BASE)/10 ML AND 20 MG (BASE)/20 ML SINGLE-DOSE VIALSABBOTT LABORATORIES5/28/02
2275-885MILRINONE LACTATE IN 5% DEXTROSE INJECTION 0.2 MG (BASE)/ML, PACKAGED IN 100 ML AND 200 ML SINGLE-DOSE FLEXIBLE CONTAINERSABBOTT LABORATORIES5/28/02
2375-936MILRINONE LACTATE INJECTION 1 MG (BASE)/ML; PACKAGED IN 10 MG (BASE)/10 ML, 20 MG (BASE)/20 ML, AND 50 MG (BASE)/50 ML SINGLE-DOSE VIALSAMERICAN PHARMACEUTICAL PARTNERS, INC.5/28/02
2476-078IFOSFAMIDE FOR INJECTION, USP 1 G AND 3 G SINGLE-DOSE VIALSAMERICAN PHARMACEUTICAL PARTNERS, INC.5/28/02
2575-586METAPROTERENOL SULFATE INHALATION SOLUTION, USP 0.4% (10 MG/2.5 ML) AND 0.6% (15 MG/2.5 ML) UNIT-DOSE VIALSMORTON GROVE PHARMACEUTICALS, INC.5/30/02
2665-082CEFPODOXIME PROXETIL FOR ORAL SUSPENSION 50 MG (BASE)/5 ML AND 100 MG (BASE)/5 MLRANBAXY LABORATORIES LIMITED5/31/02
2776-229AMCINONIDE CREAM, USP 0.1%TARO PHARMACEUTICAL INDUSTRIES LTD.5/31/02