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U.S. Department of Health and Human Services

Drugs

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Tentative Approvals - October 2005

  ANDA Number Generic Drug Name Applicant Tentative Approval Date
1 77-291 CYCLOBENZAPRINE HYDROCHLORIDE TABLETS USP, 5 MG   AMIDE PHARMACEUTICAL, INC. 10/4/2005 
2 76-950 GATIFLOXACIN TABLETS 200 MG AND 400 MG   TEVA PHARMACEUTICALS USA 10/5/2005 
3 76-714 PRAVASTATIN SODIUM TABLETS 10 MG, 20 MG, 40 MG, AND 80 MG   DR. REDDY'S LABORATORIES, LIMITED 10/5/2005 
4 77-456 RIBAVIRIN TABLETS 200 MG, 400 MG, AND 600 MG THREE RIVERS PHARMACEUTICALS, LLC 10/20/2005 
5 77-300 ZOLPIDEM TARTRATE TABLETS 5 MG AND 10 MG   PLIVA HRVATSKA D.O.O. 10/28/2005 
6 77-158 OLANZAPINE TABLETS 2.5 MG, 5 MG, 7.5 MG, 10 MG, 15 MG, AND 20 MG   SANDOZ INC. 10/31/2005 
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