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U.S. Department of Health and Human Services

Drugs

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Approvals - May 2001

  ANDA Number Drug Name Applicant Approval Date
1 75-902 FLUVOXAMINE MALEATE TABLETS 25 MG, 50 MG, AND 100 MG TORPHARM 5/7/01
2 76-032 METHYLPHENIDATE HYDROCHLORIDE EXTENDED-RELEASE TABLETS, USP 20 MG ABLE LABORATORIES, INC. 5/9/01
3 75-591 FAMOTIDINE INJECTION (PRESERVATIVE-FREE) 0.4 MG/ML (20 MG/50 ML) SINGLE-DOSE IN GALAXY PLASTIC CONTAINER. BAXTER HEALTHCARE CORPORATION 5/10/01
4 75-607 FAMOTIDINE TABLETS, USP 20 MG, AND 40 MG INVAMED INC. 5/10/01
5 75-602 AMINOCAPROIC ACID TABLETS, USP 500 MG MIKART, INC. 5/24/01
6 40-360 PERPHENAZINE ORAL SOLUTION, USP 16 MG/5 ML (CONCENTRATE) PHARMACEUTICAL ASSOCIATES, INC. 5/25/01
7 75-951 NORETHINDRONE ACETATE TABLETS, USP 5 MG BARR LABORATORIES, INC. 5/25/01
8 75-673 CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE CREAM, USP 1%/0.05% (BASE) TARO PHARMACEUTICALS U.S.A., INC. 5/29/01
9 65-001 CEFUROXIME FOR INJECTION, USP 750 MG/10 ML (VIAL); 1.5 G/20 ML (VIAL); 750 MG/100 ML (INFUSION BOTTLE); AND 1.5 G/100 ML (INFUSION BOTTLE). AMERICAN PHARMACEUTICAL PARTNERS, INC. 5/30/01
10 40-419 ACETAMINOPHEN AND CODEINE TABLETS, USP 300 MG/15 MG, 300 MG/30 MG, AND 300 MG/60 MG. MALLINCKRODT, INC. 5/31/01
11 75-312 FAMOTIDINE TABLETS, USP 10 MG (OVER-THE COUNTER USE) TEVA PHARMACEUTICALS, USA 5/31/01
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