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U.S. Department of Health and Human Services

Drugs

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Tentative Approvals - December 2003

 ANDA NumberGeneric Drug NameApplicantTentative Approval Date
175-428GABAPENTIN CAPSULES 100 MG 300 MG 400 MG  GENEVA PHARMACEUTICALS, INC.12/10/2003 
276-276LEVOFLOXACIN TABLETS 250 MG 500 MG  MYLAN PHARMACEUTICALS INC.12/10/2003 
376-488MESNA INJECTION 100 MG/ML; PACKAGED IN 1 G/10 ML MULTIPLE-DOSE VIALS  BIONICHE PHARMA (CANADA) LTD.12/17/2003 
476-448TOPIRAMATE CAPSULES 15 MG, AND 25 MG  BARR LABORATORIES, INC.12/17/2003 
576-499MOMETASONE FUROATE TOPICAL SOLUTION, USP 0.1%  ATRIX LABORATORIES, INC.12/19/2003 
676-377TERBINAFINE HYDROCHLORIDE TABLETS 250 MG (BASE)  TEVA PHARMACEUTICALS USA12/19/2003 
776-390TERBINAFINE HYDROCHLORIDE TABLETS 250 MG (BASE)  DR. REDDY'S LABORATORIES LIMITED12/19/2003 
876-446OXYCODONE HYDROCHLORIDE EXTENDED-RELEASE TABLETS 10 MG, 20 MG, AND 40 MG  IMPAX LABORATORIES, INC.12/23/2003 
976-652POLYETHYLENE GLYCOL 3350 POWDER FOR ORAL SOLUTION 17 G/SCOOPFUL  SCHWARZ PHARMA, INC.12/23/2003 
1076-617FLUCONAZOLE 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 
1176-584ALENDRONATE SODIUM TABLETS 5 MG (BASE), 10 MG (BASE), 35 MG (BASE), AND 70 MG (BASE)  MYLAN PHARMACEUTICALS, INC.