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U.S. Department of Health and Human Services

Drugs

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Tentative Approvals - December 2004

 ANDA NumberGeneric Drug NameApplicantTentative Approval Date
176-788MOMETASONE FUROATE TOPICAL SOLUTION, USP (LOTION) 0.1%  TARO PHARMACEUTICALS USA, INC.12/3/2004 
276-679MOMETASONE FUROATE CREAM, USP 0.1%  TARO PHARMACEUTICALS USA, INC.12/3/2004 
375-719SERTRALINE HYDROCHLORIDE TABLETS 25 MG (BASE), 50 MG (BASE), AND 100 MG (BASE)  IVAX PHARMACEUTICALS, INC.12/9/2004 
476-605GABAPENTIN TABLETS 600 MG AND 800 MG  RANBAXYLABORATORIES LIMITED12/9/2004 
576-610OXYCODONE HYDROCHLORIDE EXTENDED-RELEASE TABLETS 10 MG, 20 MG, AND 40 MG  TEVA PHARMACEUTICALS USA12/9/2004 
676-864METFORMIN HYDROCHLORIDE EXTENDED-RELEASE TABLETS 750 MG  TEVA PHARMACEUTICALS USA12/13/2004 
776-672GABAPENTIN ORAL SOLUTION 250 MG/5 ML  TARO PHARMACEUTICAL INDUSTRIES LTD.12/14/2004 
876-327TOPIRAMATE TABLETS 25 MG, 100 MG, AND 200 MGRANBAXY LABORATORIES LIMITED12/15/2004 
976-747ROSIGLITAZONE MALEATE TABLETS 2 MG (BASE), 4 MG (BASE), AND 8 MG (BASE)  TEVA PHARMACEUTICALS USA12/20/2004 
1076-960ONDANSETRON HYDROCHLORIDE ORAL SOLUTION 4 MG (BASE)/5 ML  ROXANE LABORATORIES, INC.12/20/2004 
1176-719AMLODIPINE BESYLATE TABLETS 2.5 MG (BASE), 5 MG (BASE), AND 10 MG (BASE)  APOTEX INC.12/29/2004