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U.S. Department of Health and Human Services

Drugs

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Tentative Approvals - November 2005

  ANDA Number Generic Drug Name Applicant Tentative Approval Date
1 77-695 LAMIVUDINE ORAL SOLUTION, 10 MG/ML   AUROBINDO PHARMA LIMITED 11/4/2005
2 77-237 ZALEPLON CAPSULES, 5 MG AND 10 MG   ROXANE LABORATORIES, INC. 11/4/2005
3 77-284 BUPROPION HYDROCHLORIDE EXTENDED-RELEASE TABLETS USP, 150 MG AND 300 MG   ANCHEN PHARMACEUTICALS, INC. 11/14/2005
4 76-948 GATIFLOXACIN TABLETS, 200 MG AND 400 MG   ZYDUS PHARMACEUTICALS USA, INC. 11/25/2005 
5 77-239 ZALEPON CAPSULES, 5 MG AND 10 MG   TEVA PHARMACEUTICALS USA 11/25/2005 
6 76-310 CABERGOLINE TABLETS, 0.5 MG   PAR PHARMACEUTICAL INC. 11/30/2005 
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