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U.S. Department of Health and Human Services

Drugs

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Tentative Approvals - July 2005

  ANDA Number Generic Drug Name Applicant Tentative Approval Date
1 77-672 STAVUDINE CAPSULES USP, 30 MG AND 40 MG   AUROBINDO PHARMA LIMITED 7/1/2005 
2 77-558 LAMIVUDINE AND ZIDOVUDINE TABLETS 150 MG/300 MG   AUROBINDO PHARMA LTD. 7/6/2005 
3 76-715 MODAFINIL TABLETS 100 MG AND 200 MG   CARLSBAD TERCHNOLOGY, INC. 7/13/2005 
4 77-327 ZIDOVUDINE TABLETS USP, 300 MG   RANBAXY LABORATORIES LIMITED 7/13/2005 
5 76-914 TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN TABLETS 37.5 MG/325 MG   TEVA PHARMACEUTICALS USA 7/18/2005 
6 76-447 FEXOFENADINE HYDROCHLORIDE TABLETS 30 MG, 60 MG, AND 180 MG   TEVA PHARMACEUTICALS, USA 7/19/2005 
7 76-875 GLIMEPIRIDE TABLETS 1 MG, 2 MG, 4 MG, AND 8 MG   RANBAXY LABORATORIES LIMITED 7/20/2005 
8 76-944 SERTRALINE HYDROCHLORIDE TABLETS 25 MG (BASE), 50 MG (BASE), AND 100 MG (BASE)   ANDRX PHARMACEUTICALS, LLC 7/21/2005 
9 76-844 ZIDOVUDINE TABLETS USP, 300 MG   ROXANE LABORATORIES, INC. 7/27/2005 
10 77-366 GLIMEPIRIDE TABLETS 3 MG AND 6 MG   RANBAXY LABORATORIES LIMITED 7/27/2005 
11 77-009 ONDANSETRON ORAL SOLUTION USP, 4 MG/5 ML   TARO PHARMACEUTICAL INDUSTRIES, LTD. 7/28/2005 
12 76-572 SUMATRIPTAN SUCCINATE TABLETS 100 MG (BASE)   RANBAXY LABORATORIES LIMITED 7/29/2005 
13 76-554 SUMATRIPTAN SUCCINATE TABLETS 25 MG (BASE) AND 50 MG (BASE)   RANBAXY LABORATORIES LIMITED 7/29/2005 
14 76-933 SUMATRIPTAN SUCCINATE TABLETS 25 MG (BASE), 50 MG (BASE), AND 100 MG (BASE)   COBALT PHARMACEUTICALS, INC. 7/29/2005 
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