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U.S. Department of Health and Human Services

Drugs

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Approvals - February 2003

 ANDA NumberGeneric Drug NameApplicantApproval Date
176-028VINORELBINE TARTRATE INJECTION 10 MG (BASE)/ML; PACKAGED IN 10 MG/ML AND 50 MG/5 ML SINGLE-DOSE VIALSGENSIA SICOR PHARMACEUTICALS, INC.2/3/03
275-822LORATADINE ORALLY DISINTEGRATING TABLETS (OTC) 10 MGWYETH CONSUMER HEALTHCARE2/10/03
340-392PREDNISONE TABLETS, USP 20 MGVINTAGE PHARMACEUTICALS, INC.2/12/03
440-433LIDOCAINE HYDROCHLORIDE JELLY, USP 2% (5 ML & 30 ML TUBES)AKORN INC.2/12/03
570-929TAMOXIFEN CITRATE TABLETS, USP 10 MG (BASE) 20 MG (BASE)BARR LABORATORIES, INC.2/20/03
674-732TAMOXIFEN CITRATE TABLETS, USP 10 MG (BASE) 20 MG (BASE)MYLAN PHARMACEUTICALS, INC.2/20/03
774-858TAMOXIFEN CITRATE TABLETS, USP 20 MG (BASE)PHARMACHEMIE B.V.2/20/03
875-740TAMOXIFEN CITRATE TABLETS, USP 10 MG (BASE) 20 MG (BASE)IVAX PHARMACEUTICALS, INC.2/20/03
975-766CALCITRIOL INJECTION 0.001 MG/ML AND 0.002 MG/ML PACKAGED IN 1 ML SINGLE-DOSE VIALSaaiPHARMA, INC.2/20/03
1075-797TAMOXIFEN CITRATE TABLETS, USP 10 MG (BASE)TEVA PHARMACEUTICALS USA2/20/03
1176-027TAMOXIFEN CITRATE TABLETS, USP 10 MG (BASE) AND 20 MG (BASE)ROXANE LABORATORIES, INC.2/20/03
1276-179TAMOXIFEN CITRATE TABLETS, USP 10 MG (BASE) AND 20 MG (BASE)ANDRX PHARMACEUTICALS, L.L.C.2/20/03
1375-706LORATADINE & PSEUDOEPHEDRINE SULFATE EXTENDED-RELEASE TABLET 10 MG/240 MG (24-HOUR FORMULATION) (OTC)ANDRX PHARMACEUTICALS, L.L.C.2/21/03
1440-447ACETAMINOPHEN AND CODEINE PHOSPHATE TABLETS, USP 500 MG/15 MGANDRX PHARMACEUTICALS, L.L.C.2/26/03
1576-400PROPRANOLOL HYDROCHLORIDE INJECTION, USP 1 MG/MLSABEX, INC.2/26/03
1640-401PREDNISOLONE SYRUP, USP 15 MG/5 MLHI-TECH PHARMACAL CO., INC.2/27/03
1740-449PROMETHAZINE HYDROCHLORIDE SUPPOSITORIES, USP 50 MGABLE LABORATORIES, INC.2/27/03
1875-438MINOXIDIL TOPICAL SOLUTION, USP (FOR MEN) 5% (OTC)MORTON GROVE PHARMACEUTICALS, INC.2/27/03