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U.S. Department of Health and Human Services

Drugs

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Approvals - October 2003

 ANDA NumberGeneric Drug NameApplicantApproval Date
140-416WARFARIN SODIUM TABLETS, USP 1 MG, 2 MG, 2.5 MG, 3 MG 4 MG, 5 MG, 6 MG, 7.5 MG, AND 10 MG  UPSHER-SMITH LABORATORIES, INC.10/2/2003 
276-048OMEPRAZOLE DELAYED-RELEASE CAPSULES 10 MG AND 20 MG  TORPHARM10/6/2003 
365-151CYCLOSPORINE INJECTION, USP 50 MG/ML PACKAGED IN 250 MG/5 ML AMPOULES  PHARMAFORCE, INC.10/7/2003 
440-440AMPHETAMINE AND DEXTROAMPHETAMINE TABLETS (MIXED SALTS) 5 MG, 7.5 MG, 10 MG, 12.5 MG, 15 MG, 20 MG, AND 30 MG  MALLINCKRODT, INC.10/7/2003 
540-512PYRIDOSTIGMINE BROMIDE TABLETS, USP 60 MG  BARR LABORATORIES, INC.10/8/2003 
676-401VINCRISTINE SULFATE INJECTION, USP 1 MG/ML; PACKAGED IN 5 MG/5 ML MULTIPLE-DOSE VIALS  AMERICAN PHARMACEUTICAL PARTNERS, INC.10/28/2003 
776-281TIZANIDINE HYDROCHLORIDE TABLETS 2 MG (BASE AND 4 MG (BASE)  AMIDE PHARMACEUTICAL, INC.10/20/2003 
840-525PHENTERMINE HYDROCHLORIDE CAPSULES, USP 30 MG  MUTUAL PHARMACEUTICAL COMPANY, INC.10/23/2003 
940-527PHENTERMINE HYDROCHLORIDE CAPSULES, USP 37.5 MG  MUTUAL PHARMACEUTICAL COMPANY, INC.10/23/2003 
1040-526PHENTERMINE HYDROCHLORIDE TABLETS, USP 37.5 MG  MUTUAL PHARMACEUTICAL COMPANY, INC.10/23/2003 
1175-868FENOFIBRATE CAPSULES (MICRONIZED) 67 MG, 134 MG, AND 200 MG  IMPAX LABORATORIES, INC.10/27/2003 
1265-126CEFUROXIME AXETIL TABLETS, USP 250 MG (BASE) AND 500 MG (BASE)  BIOCHEMIE U.S., INC.10/28/2003 
1376-545METFORMIN HYDROCHLORIDE EXTENDED-RELEASE TABLETS 500 MG  IVAX PHARMACEUTICALS, INC.10/28/2003 
1440-520HYDROCODONE BITARTRATE AND ACETAMINOPHEN ORAL SOLUTION 7.5 MG/500 MG PER 15 ML  VINTAGE PHARMACEUTICALS, LLC10/30/2003 
1540-462NOREPINEPHRINE BITARTRATE INJECTION, USP 1 MG (BASE)/ML, PACKAGED IN 4 MG (BASE)/4 ML VIALS  BEDFORD LABORATORIES10/31/2003 
1675-557RANITIDINE CAPSULES 150 MG AND 300 MG  TEVA PHARMACEUTICALS USA10/31/2003