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U.S. Department of Health and Human Services

Drugs

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Tentative Approvals - March 2006

  ANDA Number Generic Drug Name Applicant Tentative Approval Date
1 76-317 TOPIRAMATE TABLETS 50 MG   TEVA PHARMACEUTICALS USA 3/3/2006 
2 77-447 MOMETASONE FUROATE CREAM USP, 0.1%   G & W LABORATORIES, INC. 3/7/2006 
3 77-678 MOMETASONE FUROATE TOPICAL SOLUTION USP, 0.1%   G & W LABORATORIES, INC. 3/7/2006 
4 76-974 ONDANSETRON INJECTION USP, 2 MG/ML; PACKAGED IN 40 MG/20 ML MULTIPLE-DOSE VIALS   AMERICAN PHARMACEUTICAL PARTNERS, INC. 3/7/2006 
5 76-972 ONDANSETRON INJECTION USP, (PRESERVATIVE-FREE) 2 MG/ML; PACKAGED IN 4 MG/2 ML SINGLE-DOSE VIALS   AMERICAN PHARMACEUTICAL PARTNERS, INC. 3/7/2006 
6 77-614 CARVEDILOL TABLETS 3.125 MG, 6.25 MG, 12.5 MG, AND 25 MG   ZYDUS PHARMACEUTICALS USA, INC. 3/10/2006 
7 77-200 KETOTIFEN FUMARATE OPHTHALMIC SOLUTION 0.025%   ALCON RESEARCH, LTD. 3/17/2006 
8 77-511 TERBINAFINE HYDROCHLORIDE CREAM 1%   TARO PHARMACEUTICALS USA INC. 3/22/2006 
9 76-954 GATIFLOXACIN TABLETS 200 MG AND 400 MG   DR. REDDY'S LABORATORIES LIMITED 3/27/2006 
10 77-137 TERBINAFINE HYDROCHLORIDE TABLETS, 250 MG (BASE)   WATSON LABORATORIES, INC. 3/28/2006 
11 77-131 RIVASTIGMINE TARTRATE CAPSULES, 1.5 MG (BASE), 3 MG (BASE), 4.5 MG (BASE), AND 6 MG (BASE)   SUN PHARMACEUTICAL INDUSTRIES LTD. 3/29/2006 
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