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U.S. Department of Health and Human Services

Drugs

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Tentative Approvals - August 2001

  ANDA Number Drug Name Applicant Tentative Approval Date
1 75-852 MILRINONE LACTATE INJECTION 1 MG (BASE)/ML BAXTER PHARMACEUTICAL PRODUCTS, INC. 8/2/01
2 75-022 BUSPIRONE HYDROCHLORIDE TABLETS, USP 15 MG (NOTE: 5 MG & 10 MG STRENGTHS WERE PREVIOUSLY TENTATIVELY APPROVED). TEVA PHARMACEUTICALS, USA 8/3/01
3 75-903 LISINOPRIL TABLETS, USP 2.5 MG 5 MG 10 MG, 20 MG 30 MG AND 40 MG GENEVA PHARMACEUTICALS TECHNOLOGY CORP. 8/14/01
4 76-030 FLECAINIDE ACETATE TABLETS, USP 50 MG, 100 MG, AND 150 MG GENEVA PHARMACEUTICALS TECHNOLOGY CORP. 8/20/01
5 75-761 AMIODARONE HYDROCHLORIDE INJECTION 50 MG/ML (3 ML VIALS) AMERICAN PHARMACEUTICAL PARTNERS, INC. 8/23/01
6 76-006 FLUOXETINE HYDROCHLORIDE TABLETS 10 MG (BASE) DR. REDDY'S LABORATORIES LIMITED 8/23/01
7 75-773 PAMIDRONATE DISODIUM FOR INJECTION 30 MG/VIAL, AND 90 MG/VIAL AMERICAN PHARMACEUTICAL PARTNERS, INC. 8/24/01
8 76-016 FLUOXETINE ORAL SOLUTION, USP 20 MG/5 ML ESI LEDERLE 8/24/01
9 75-810 FLUOXETINE HYDROCHLORIDE TABLETS 10 MG (BASE) BARR LABORATORIES, INC. 8/31/01
10 75-817 CIPROFLOXACIN TABLETS, USP 100 MG, 250 MG, 500 MG, AND 750 MG GENPHARM INC. 8/31/01
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