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U.S. Department of Health and Human Services

Drugs

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Approvals - October 2003

  ANDA Number Generic Drug Name Applicant Approval Date
1 40-416 WARFARIN 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 
2 76-048 OMEPRAZOLE DELAYED-RELEASE CAPSULES 10 MG AND 20 MG   TORPHARM 10/6/2003 
3 65-151 CYCLOSPORINE INJECTION, USP 50 MG/ML PACKAGED IN 250 MG/5 ML AMPOULES   PHARMAFORCE, INC. 10/7/2003 
4 40-440 AMPHETAMINE 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 
5 40-512 PYRIDOSTIGMINE BROMIDE TABLETS, USP 60 MG   BARR LABORATORIES, INC. 10/8/2003 
6 76-401 VINCRISTINE SULFATE INJECTION, USP 1 MG/ML; PACKAGED IN 5 MG/5 ML MULTIPLE-DOSE VIALS   AMERICAN PHARMACEUTICAL PARTNERS, INC. 10/28/2003 
7 76-281 TIZANIDINE HYDROCHLORIDE TABLETS 2 MG (BASE AND 4 MG (BASE)   AMIDE PHARMACEUTICAL, INC. 10/20/2003 
8 40-525 PHENTERMINE HYDROCHLORIDE CAPSULES, USP 30 MG   MUTUAL PHARMACEUTICAL COMPANY, INC. 10/23/2003 
9 40-527 PHENTERMINE HYDROCHLORIDE CAPSULES, USP 37.5 MG   MUTUAL PHARMACEUTICAL COMPANY, INC. 10/23/2003 
10 40-526 PHENTERMINE HYDROCHLORIDE TABLETS, USP 37.5 MG   MUTUAL PHARMACEUTICAL COMPANY, INC. 10/23/2003 
11 75-868 FENOFIBRATE CAPSULES (MICRONIZED) 67 MG, 134 MG, AND 200 MG   IMPAX LABORATORIES, INC. 10/27/2003 
12 65-126 CEFUROXIME AXETIL TABLETS, USP 250 MG (BASE) AND 500 MG (BASE)   BIOCHEMIE U.S., INC. 10/28/2003 
13 76-545 METFORMIN HYDROCHLORIDE EXTENDED-RELEASE TABLETS 500 MG   IVAX PHARMACEUTICALS, INC. 10/28/2003 
14 40-520 HYDROCODONE BITARTRATE AND ACETAMINOPHEN ORAL SOLUTION 7.5 MG/500 MG PER 15 ML   VINTAGE PHARMACEUTICALS, LLC 10/30/2003 
15 40-462 NOREPINEPHRINE BITARTRATE INJECTION, USP 1 MG (BASE)/ML, PACKAGED IN 4 MG (BASE)/4 ML VIALS   BEDFORD LABORATORIES 10/31/2003 
16 75-557 RANITIDINE CAPSULES 150 MG AND 300 MG   TEVA PHARMACEUTICALS USA 10/31/2003 

 

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