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U.S. Department of Health and Human Services

Drugs

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Tentative Approvals - June 2005

  ANDA Number Generic Drug Name Applicant Tentative Approval Date
1 77-214 ZOLPIDEM TARTRATE TABLETS 5 MG AND 10 MG   ROXANE LABORATORIES, INC. 6/6/2005 
2 77-464 LAMIVUDINE TABLETS 150 MG AND 300 MG   AUROBINDO PHARMA LIMITED 6/15/2005 
3 77-444 TERBINAFINE HYDROCHLORIDE TABLETS 250 MG (BASE)   RANBAXY LABORATORIES, LTD. 6/16/2005 
4 76-506 ONDANSETRON ORALLY DISINTEGRATING TABLETS 4 MG, AND 8 MG   KALI LABORATORIES, INC. 6/17/2005 
5 77-304 CAFFEINE CITRATE ORAL SOLUTION 10 MG (BASE)/ML   PHARMAFORCE, INC. 6/20/2005 
6 77-233 CAFFEINE CITRATE INJECTION 20 MG (BASE)/ML   PHARMAFORCE, INC. 6/20/2005 
7 77-521 NEVIRAPINE TABLETS 200 MG   AUROBINDO PHARMA LIMITED 6/20/2005 
8 77-429 NEVIRAPINE TABLETS 200 MG   RANBAXY LABORATORIES LIMITED 6/20/2005 
9 77-073 AMLODIPINE BESYLATE TABLETS 2.5 MG (BASE), 5 MG (BASE), AND 10 MG (BASE)   WATSON LABORATORIES, INC. 6/22/2005 
10 77-673 EFAVIRENZ TABLETS 600 MG   AUROBINDO PHARMA LIMITED 6/24/2005 
11 76-802 GLIMEPIRIDE TABLETS 1 MG, 2 MG, AND 4 MG   TEVA PHARMACEUTICALS USA 6/27/2005 
12 77-013 PRAVASTATIN SODIUM TABLETS 10 MG, 20 MG, 40 MG, AND 80 MG   GENPHARM INC. 6/27/2005 
13 77-223 TERBINAFINE HYDROCHLORIDE TABLETS 250 MG (BASE)   ROXANE LABORATORIES, INC. 6/27/2005 
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