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U.S. Department of Health and Human Services

Drugs

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Tentative Approvals - March 2005

  ANDA Number Generic Drug Name Applicant Tentative Approval Date
1 76-520 FENOFIBRATE TABLETS 54 MG, 107 MG, AND 160 MG   PAR PHARMACEUTICAL 3/3/2005 
2 76-575 TOPIRAMATE CAPSULES 15 MG AND 25 MG   TEVA PHARMACEUTICALS USA 3/9/2005 
3 77-065 TERBINAFINE HYDROCHLORIDE TABLETS 250 MG (BASE)   GEDEON RICHTER LTD. 3/10/2005 
4 76-799 PIOGLITAZONE HYDROCHLORIDE TABLETS 15 MG (BASE), 30 MG (BASE), AND 45 MG (BASE)   ALPHAPHARM PTY, LTD. 3/15/2005 
5 76-415 OLANZAPINE TABLETS 2.5 MG, 5 MG, 7.5 MG, 10 MG, 15 MG, AND 20 MG   TEVA PHARMACEUTICALS USA 3/24/2005 
6 76-846 AMLODIPINE BESYLATE TABLETS 2.5 MG (BASE), 5 MG (BASE), AND 10 MG (BASE)   TEVA PHARMACEUTICALS USA 3/24/2005 
7 76-866 OLANZAPINE TABLETS 2.5 MG, 5 MG, 7.5 MG, 10 MG, 15 MG, AND 20 MG   MYLAN PHARMACEUTICALS INC. 3/25/2005 
8 76-826 LEVOFLOXACIN OPHTHALMIC SOLUTION 0.5%   HI-TECH PHARMACAL CO., INC. 3/28/2005 
9 75-959 OCTREOTIDE ACETATE INJECTION (MULTIPLE DOSE VIALS) 0.2 MG/ML AND 1.0 MG/ML   SICOR PHARMACEUTICALS, INC. 3/28/2005 
10 75-957 OCTREOTIDE ACETATE INJECTION 0.05 MG/ML, 0.1 MG/ML, AND 0.5 MG/ML   SICOR PHARMACEUTICALS, INC. 3/28/2005 
11 76-904 RISPERIDONE ORAL SOLUTION 1 MG/ML   ROXANE LABORATORIES, INC. 3/30/2005 
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