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U.S. Department of Health and Human Services

Drugs

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Tentative Approvals - October 2005

 ANDA NumberGeneric Drug NameApplicantTentative Approval Date
177-291CYCLOBENZAPRINE HYDROCHLORIDE TABLETS USP, 5 MG  AMIDE PHARMACEUTICAL, INC.10/4/2005 
276-950GATIFLOXACIN TABLETS 200 MG AND 400 MG  TEVA PHARMACEUTICALS USA10/5/2005 
376-714PRAVASTATIN SODIUM TABLETS 10 MG, 20 MG, 40 MG, AND 80 MG  DR. REDDY'S LABORATORIES, LIMITED10/5/2005 
477-456RIBAVIRIN TABLETS 200 MG, 400 MG, AND 600 MGTHREE RIVERS PHARMACEUTICALS, LLC10/20/2005 
577-300ZOLPIDEM TARTRATE TABLETS 5 MG AND 10 MG  PLIVA HRVATSKA D.O.O.10/28/2005 
677-158OLANZAPINE TABLETS 2.5 MG, 5 MG, 7.5 MG, 10 MG, 15 MG, AND 20 MG  SANDOZ INC.10/31/2005