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U.S. Department of Health and Human Services

Drugs

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Approvals - October 2001

 ANDA NumberDrug NameApplicantApproval Date
175-839MINOXIDIL TOPICAL SOLUTION, USP (FOR MEN) 5% (OTC)NOVEX PHARMA10/1/01
275-843OXAPROZIN TABLETS 600 MGPUREPAC PHARMACEUTICAL CO.10/3/01
364-163GENTAMICIN SULFATE OPHTHALMIC SOLUTION, USP 0.3% (BASE)AKORN NEW JERSEY, INC.10/12/01
475-765CALCITRIOL CAPSULES 0.25 MCG AND 0.5 MCGTEVA PHARMACEUTICALS USA10/12/01
575-515SOTALOL HYDROCHLORIDE TABLETS 80 MG, 120 MG, 160 MG, AND 240 MGMUTUAL PHARMACEUTICAL COMPANY10/15/01
675-835IPRATROPIUM BROMIDE INHALATION SOLUTION 0.02%BAUSCH & LOMB PHARMACEUTICALS, INC.10/15/01
775-909ENALAPRIL MALEATE AND HYDROCHLOROTHIAZIDE TABLETS, USP 5 MG/12.5 MG AND 10 MG/25 MGDR. REDDY'S LABORATORIES, LTD.10/15/01
875-950FLUVOXAMINE MALEATE TABLETS 50 MG AND 100 MGGENPHARM INC.10/15/01
965-042BLEOMYCIN FOR INJECTION, USP 15 UNITS (BASE)/VIAL AND 30 UNITS (BASE)/VIALBEDFORD LABORATORIES10/17/01
1075-940DACARBAZINE FOR INJECTION, USP 200 MG/VIALFAULDING PHARMACEUTICAL CO.10/18/01
1140-423PREDNISOLONE SYRUP, USP 5 MG/5 MLKV PHARMACEUTICAL COMPANY10/22/01
1275-695BUTORPHANOL TARTRATE INJECTION, USP (PRESERVATIVE-FREE) 1 MG/ML (1 ML VIAL); 2 MG/ML (1 ML & 2 ML VIALS)APOTEX CORP.10/23/01
1375-697BUTORPHANOL TARTRATE INJECTION, USP 2 MG/ML (MULTIPLE-DOSE VIAL)APOTEX CORP.10/23/01
1475-659NIFEDIPINE EXTENDED-RELEASE TABLETS 60 MGELAN PHARMACEUTICAL RESEARCH CORPORATION10/26/01
1576-112IBUPROFEN TABLETS, USP 400 MG, 600 MG, AND 800 MGDR. REDDY'S LABORATORIES, LTD.10/31/01