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U.S. Department of Health and Human Services

Drugs

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Tentative Approvals - March 2006.

 ANDA NumberGeneric Drug NameApplicantTentative Approval Date
176-317TOPIRAMATE TABLETS 50 MG  TEVA PHARMACEUTICALS USA3/3/2006 
277-447MOMETASONE FUROATE CREAM USP, 0.1%  G & W LABORATORIES, INC.3/7/2006 
377-678MOMETASONE FUROATE TOPICAL SOLUTION USP, 0.1%  G & W LABORATORIES, INC.3/7/2006 
476-974ONDANSETRON INJECTION USP, 2 MG/ML; PACKAGED IN 40 MG/20 ML MULTIPLE-DOSE VIALS  AMERICAN PHARMACEUTICAL PARTNERS, INC.3/7/2006 
576-972ONDANSETRON INJECTION USP, (PRESERVATIVE-FREE) 2 MG/ML; PACKAGED IN 4 MG/2 ML SINGLE-DOSE VIALS  AMERICAN PHARMACEUTICAL PARTNERS, INC.3/7/2006 
677-614CARVEDILOL TABLETS 3.125 MG, 6.25 MG, 12.5 MG, AND 25 MG  ZYDUS PHARMACEUTICALS USA, INC.3/10/2006 
777-200KETOTIFEN FUMARATE OPHTHALMIC SOLUTION 0.025%  ALCON RESEARCH, LTD.3/17/2006 
877-511TERBINAFINE HYDROCHLORIDE CREAM 1%  TARO PHARMACEUTICALS USA INC.3/22/2006 
976-954GATIFLOXACIN TABLETS 200 MG AND 400 MG  DR. REDDY'S LABORATORIES LIMITED3/27/2006 
1077-137TERBINAFINE HYDROCHLORIDE TABLETS, 250 MG (BASE)  WATSON LABORATORIES, INC.3/28/2006 
1177-131RIVASTIGMINE TARTRATE CAPSULES, 1.5 MG (BASE), 3 MG (BASE), 4.5 MG (BASE), AND 6 MG (BASE)  SUN PHARMACEUTICAL INDUSTRIES LTD.3/29/2006