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U.S. Department of Health and Human Services

Drugs

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Approvals - April 2003

 ANDA NumberGeneric Drug NameApplicantApproval Date
176-391ALBUTEROL SULFATE INHALATION SOLUTION 0.5% (BASE)NOVEX PHARMA4/1/2003 
276-371TIZANIDINE HYDROCHLORIDE TABLETS 2 MG (BASE) AND 4 MG (BASE)BARR LABORATORIES, INC.4/9/2003 
375-883AMMONIUM LACTATE CREAM 12% (BASE)TARO PHARMACEUTICALS U.S.A., INC.4/10/2003 
475-401DILTIAZEM HYDROCHLORIDE EXTENDED-RELEASE CAPSULES, USP 120 MG, 180 MG, 240 MG, 300 MG, AND 360 MG (ONCE-A-DAY DOSAGE)ANDRX PHARMACEUTICALS, L.L.P.4/10/2003 
576-023HYDROCODONE BITARTRATE AND IBUPROFEN TABLETS 7.5 MG/200 MGTEVA PHARMACEUTICALS USA4/11/2003 
640-504PROMETHAZINE HYDROCHLORIDE SUPPOSITORIES, USP 12.5 MG, AND 25 MGABLE LABORATORIES, INC.4/11/2003 
776-356ISOTRETINOIN CAPSULES, USP 10 MGBARR LABORATORIES, INC.4/11/2003 
876-135ISOTRETINOIN CAPSULES, USP 20 MG AND 40 MGBARR LABORATORIES, INC.4/11/2003 
940-491DEXAMETHASONE SODIUM PHOSPHATE INJECTION, USP EQ. TO 10 MG DEXAMETHASONE PHOSPHATE/ML (PRESERVATIVE-FREE)AMERICAN PHARMACEUTICAL PARTNERS, INC.4/11/2003 
1065-131MINOCYCLINE HYDROCHLORIDE TABLETS, USP 50 MG (BASE), 75 MG (BASE), AND 100 MG (BASE)PAR PHARMACEUTICAL, INC.4/16/2003 
1176-156IPRATROPIUM BROMIDE NASAL SOLUTION (NASAL SPRAY) 0.03% (0.021 MG/SPRAY)NOVEX PHARMA4/18/2003 
1276-155IPRATROPIUM BROMIDE NASAL SOLUTION (NASAL SPRAY) 0.06% (0.042 MG/SPRAY)NOVEX PHARMA4/18/2003 
1376-369PERMETHRIN CREAM 5%CLAY-PARK LABS, INC.4/21/2003 
1440-467TRIAMCINOLONE ACETONIDE LOTION, USP 0.025% AND 0.1%ALTANA, INC.4/21/2003 
1576-382LITHIUM CARBONATE EXTENDED-RELEASE TABLETS, USP 300 MGABLE LABORATORIES, INC.4/21/2003 
1640-502PYRIDOSTIGMINE BROMIDE TABLETS, USP 60 MGIMPAX LABORATORIES, INC.4/24/2003 
1765-118CEFUROXIME AXETIL TABLETS, USP 125 MG (BASE), 250 MG (BASE), AND 500 MG (BASE)RANBAXY LABORATORIES LIMITED4/25/2003 
1840-458CARBINOXAMINE MALEATE ORAL SOLUTION 4 MG/5 MLMIKART, INC.4/25/2003 
1976-394AMIODARONE HYDROCHLORIDE INJECTION 50 MG/ML; PACKAGED IN 150 MG/3 ML SINGLE-USE VIALSAPOTEX CORP.4/25/2003 
2076-444HYDROMORPHONE HYDROCHLORIDE INJECTION, USP 10 MG/ML; PACKAGED IN 10 MG/1 ML, 50 MG/5 ML, AND 500 MG/50 ML SINGLE-USE VIALSFAULDING PHARMACEUTICAL COMPANY4/25/2003 
2174-504TAMOXIFEN CITRATE TABLETS, USP 10 MG (BASE) AND 20 MG (BASE)TEVA PHARMACEUTICALS, USA4/28/2003 
2240-475DIHYDROERGOTAMINE MESYLATE INJECTION, USP 1 MG/ML; SINGLE-DOSE AMPULESPADDOCK LABORATORIES, INC.4/28/2003 
2375-862LEVONORGESTREL AND ETHINYL ESTRADIOL TABLETS, USP 0.1 MG AND 0.02 MG, RESPECTIVELY, (21- AND 28-DAY REGIMENS)BARR LABORATORIES, INC.4/29/2003