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U.S. Department of Health and Human Services

Drugs

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Tentative Approvals - October 2006

 ANDA NumberGeneric Drug NameApplicantTentative Approval Date
178-112DIDANOSINE FOR ORAL SOLUTION (PEDIATRIC POWDER), 10 MG/MLAUROBINDO PHARMA LIMITED INC.10/5/2006
276-440RISPERIDONE ORAL SOLUTION, 1 MG/MLTEVA PHARMACEUTICALS USA10/11/2006
377-126AMIFOSTINE FOR INJECTION USP, 500 MG/VIALSUN PHARMACEUTICALS INDUSTRIES LTD10/16/2006
477-332SUMATRIPTAN SUCCINATE INJECTION, 6 MG (BASE)/0.5 MLSPECTRUM PHARMACEUTICALS, INC.10/16/2006
576-939PRAVASTATIN SODIUM TABLETS, 80 MGCOBALT PHARMACEUTICALS, INC.10/23/2006
678-016ZOLPIDEM TARTRATE TABLETS, 5 MG AND 10 MGGENPHARM INC.10/30/2006
777-388ZOLPIDEM TATRTATE TALBETS, 5 MG AND 10 MGCIPLA LIMITED10/31/2006