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Tentative Approvals - October 2006

  ANDA Number Generic Drug Name Applicant Tentative Approval Date
1 78-112 DIDANOSINE FOR ORAL SOLUTION (PEDIATRIC POWDER), 10 MG/ML AUROBINDO PHARMA LIMITED INC. 10/5/2006
2 76-440 RISPERIDONE ORAL SOLUTION, 1 MG/ML TEVA PHARMACEUTICALS USA 10/11/2006
3 77-126 AMIFOSTINE FOR INJECTION USP, 500 MG/VIAL SUN PHARMACEUTICALS INDUSTRIES LTD 10/16/2006
4 77-332 SUMATRIPTAN SUCCINATE INJECTION, 6 MG (BASE)/0.5 ML SPECTRUM PHARMACEUTICALS, INC. 10/16/2006
5 76-939 PRAVASTATIN SODIUM TABLETS, 80 MG COBALT PHARMACEUTICALS, INC. 10/23/2006
6 78-016 ZOLPIDEM TARTRATE TABLETS, 5 MG AND 10 MG GENPHARM INC. 10/30/2006
7 77-388 ZOLPIDEM TATRTATE TALBETS, 5 MG AND 10 MG CIPLA LIMITED 10/31/2006

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Date created: November 15, 2006

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