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U.S. Department of Health and Human Services

Drugs

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Tentative Approvals - November 2005

 ANDA NumberGeneric Drug NameApplicantTentative Approval Date
177-695LAMIVUDINE ORAL SOLUTION, 10 MG/ML  AUROBINDO PHARMA LIMITED11/4/2005
277-237ZALEPLON CAPSULES, 5 MG AND 10 MG  ROXANE LABORATORIES, INC.11/4/2005
377-284BUPROPION HYDROCHLORIDE EXTENDED-RELEASE TABLETS USP, 150 MG AND 300 MG  ANCHEN PHARMACEUTICALS, INC.11/14/2005
476-948GATIFLOXACIN TABLETS, 200 MG AND 400 MG  ZYDUS PHARMACEUTICALS USA, INC.11/25/2005 
577-239ZALEPON CAPSULES, 5 MG AND 10 MG  TEVA PHARMACEUTICALS USA11/25/2005 
676-310CABERGOLINE TABLETS, 0.5 MG  PAR PHARMACEUTICAL INC.11/30/2005