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U.S. Department of Health and Human Services

Drugs

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Tentative Approvals - December 2003

  ANDA Number Generic Drug Name Applicant Tentative Approval Date
1 75-428 GABAPENTIN CAPSULES 100 MG 300 MG 400 MG   GENEVA PHARMACEUTICALS, INC. 12/10/2003 
2 76-276 LEVOFLOXACIN TABLETS 250 MG 500 MG   MYLAN PHARMACEUTICALS INC. 12/10/2003 
3 76-488 MESNA INJECTION 100 MG/ML; PACKAGED IN 1 G/10 ML MULTIPLE-DOSE VIALS   BIONICHE PHARMA (CANADA) LTD. 12/17/2003 
4 76-448 TOPIRAMATE CAPSULES 15 MG, AND 25 MG   BARR LABORATORIES, INC. 12/17/2003 
5 76-499 MOMETASONE FUROATE TOPICAL SOLUTION, USP 0.1%   ATRIX LABORATORIES, INC. 12/19/2003 
6 76-377 TERBINAFINE HYDROCHLORIDE TABLETS 250 MG (BASE)   TEVA PHARMACEUTICALS USA 12/19/2003 
7 76-390 TERBINAFINE HYDROCHLORIDE TABLETS 250 MG (BASE)   DR. REDDY'S LABORATORIES LIMITED 12/19/2003 
8 76-446 OXYCODONE HYDROCHLORIDE EXTENDED-RELEASE TABLETS 10 MG, 20 MG, AND 40 MG   IMPAX LABORATORIES, INC. 12/23/2003 
9 76-652 POLYETHYLENE GLYCOL 3350 POWDER FOR ORAL SOLUTION 17 G/SCOOPFUL   SCHWARZ PHARMA, INC. 12/23/2003 
10 76-617 FLUCONAZOLE INJECTION (IN 0.9% SODIUM CHLORIDE INJECTION) 2 MG/ML; PACKAGED IN 200 MG/100 ML AND 400 MG/200 ML SINGLE-DOSE VIALS   SICOR PHARMACEUTICALS, INC. 12/24/2003 
11 76-584 ALENDRONATE SODIUM TABLETS 5 MG (BASE), 10 MG (BASE), 35 MG (BASE), AND 70 MG (BASE)   MYLAN PHARMACEUTICALS, INC.
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