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U.S. Department of Health and Human Services

Drugs

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Approvals - October 2001

  ANDA Number Drug Name Applicant Approval Date
1 75-839 MINOXIDIL TOPICAL SOLUTION, USP (FOR MEN) 5% (OTC) NOVEX PHARMA 10/1/01
2 75-843 OXAPROZIN TABLETS 600 MG PUREPAC PHARMACEUTICAL CO. 10/3/01
3 64-163 GENTAMICIN SULFATE OPHTHALMIC SOLUTION, USP 0.3% (BASE) AKORN NEW JERSEY, INC. 10/12/01
4 75-765 CALCITRIOL CAPSULES 0.25 MCG AND 0.5 MCG TEVA PHARMACEUTICALS USA 10/12/01
5 75-515 SOTALOL HYDROCHLORIDE TABLETS 80 MG, 120 MG, 160 MG, AND 240 MG MUTUAL PHARMACEUTICAL COMPANY 10/15/01
6 75-835 IPRATROPIUM BROMIDE INHALATION SOLUTION 0.02% BAUSCH & LOMB PHARMACEUTICALS, INC. 10/15/01
7 75-909 ENALAPRIL MALEATE AND HYDROCHLOROTHIAZIDE TABLETS, USP 5 MG/12.5 MG AND 10 MG/25 MG DR. REDDY'S LABORATORIES, LTD. 10/15/01
8 75-950 FLUVOXAMINE MALEATE TABLETS 50 MG AND 100 MG GENPHARM INC. 10/15/01
9 65-042 BLEOMYCIN FOR INJECTION, USP 15 UNITS (BASE)/VIAL AND 30 UNITS (BASE)/VIAL BEDFORD LABORATORIES 10/17/01
10 75-940 DACARBAZINE FOR INJECTION, USP 200 MG/VIAL FAULDING PHARMACEUTICAL CO. 10/18/01
11 40-423 PREDNISOLONE SYRUP, USP 5 MG/5 ML KV PHARMACEUTICAL COMPANY 10/22/01
12 75-695 BUTORPHANOL TARTRATE INJECTION, USP (PRESERVATIVE-FREE) 1 MG/ML (1 ML VIAL); 2 MG/ML (1 ML & 2 ML VIALS) APOTEX CORP. 10/23/01
13 75-697 BUTORPHANOL TARTRATE INJECTION, USP 2 MG/ML (MULTIPLE-DOSE VIAL) APOTEX CORP. 10/23/01
14 75-659 NIFEDIPINE EXTENDED-RELEASE TABLETS 60 MG ELAN PHARMACEUTICAL RESEARCH CORPORATION 10/26/01
15 76-112 IBUPROFEN TABLETS, USP 400 MG, 600 MG, AND 800 MG DR. REDDY'S LABORATORIES, LTD. 10/31/01
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