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U.S. Department of Health and Human Services

Drugs

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Tentative Approvals - August 2001

 ANDA NumberDrug NameApplicantTentative Approval Date
175-852MILRINONE LACTATE INJECTION 1 MG (BASE)/MLBAXTER PHARMACEUTICAL PRODUCTS, INC.8/2/01
275-022BUSPIRONE HYDROCHLORIDE TABLETS, USP 15 MG (NOTE: 5 MG & 10 MG STRENGTHS WERE PREVIOUSLY TENTATIVELY APPROVED).TEVA PHARMACEUTICALS, USA8/3/01
375-903LISINOPRIL TABLETS, USP 2.5 MG 5 MG 10 MG, 20 MG 30 MG AND 40 MGGENEVA PHARMACEUTICALS TECHNOLOGY CORP.8/14/01
476-030FLECAINIDE ACETATE TABLETS, USP 50 MG, 100 MG, AND 150 MGGENEVA PHARMACEUTICALS TECHNOLOGY CORP.8/20/01
575-761AMIODARONE HYDROCHLORIDE INJECTION 50 MG/ML (3 ML VIALS)AMERICAN PHARMACEUTICAL PARTNERS, INC.8/23/01
676-006FLUOXETINE HYDROCHLORIDE TABLETS 10 MG (BASE)DR. REDDY'S LABORATORIES LIMITED8/23/01
775-773PAMIDRONATE DISODIUM FOR INJECTION 30 MG/VIAL, AND 90 MG/VIALAMERICAN PHARMACEUTICAL PARTNERS, INC.8/24/01
876-016FLUOXETINE ORAL SOLUTION, USP 20 MG/5 MLESI LEDERLE8/24/01
975-810FLUOXETINE HYDROCHLORIDE TABLETS 10 MG (BASE)BARR LABORATORIES, INC.8/31/01
1075-817CIPROFLOXACIN TABLETS, USP 100 MG, 250 MG, 500 MG, AND 750 MGGENPHARM INC.8/31/01