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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 76-692 AMLODIPINE BESYLATE TABLETS, 2.5 MG (BASE), 5 MG (BASE), AND 10 MG (BASE)   DR. REDDY'S LABORATORIES, LTD. 4/3/2006 
2 77-513 RAMIPRIL CAPSULES 1.25 MG 2.5 MG 5 MG 10 MG   PUREPAC PHARMACEUTICAL CO. 4/10/2006 
3 77-081 FEXOFENADINE HYDROCHLORIDE TABLETS 30 MG 60 MG 180 MG   MYLAN PHARMACEUTICALS, INC. 4/11/2006 
4 77-729 ONDANSETRON HYDROCHLORIDE TABLETS 4 MG (BASE), 8 MG (BASE), AND 24 MG (BASE)   TARO PHARMACEUTICAL INDUSTRIES, LTD. 4/14/2006 
5 77-387 ONDANSETRON INJECTION USP, (PRESERVATIVE-FREE) 2 MG/ML; PACKAGED IN 4 MG/2 ML SINGLE-DOSE VIALS.   PHARMAFORCE, INC. 4/14/2006 
6 77-578 FINASTERIDE TABLETS USP, 5 MG   MYLAN PHARMACEUTICALS, INC. 4/14/2006 
7 77-691 SIMVASTATIN TABLETS USP, 5 MG, 10 MG, 20 MG, 40 MG, AND 80 MG   AUROBINDO PHARMA LIMITED 4/19/2006 
8 77-057 PANTOPRAZOLE SODIUM DELAYED-RELEASE TABLETS 20 MG (BASE) AND 40 MG (BASE)   SANDOZ INC. 4/19/2006 
9 77-056 PANTOPRAZOLE SODIUM DELAYED-RELEASE TABLETS 20 MG (BASE) AND 40 MG (BASE)   TEVA PHARMACEUTICALS USA 4/19/2006 
10 77-652 LEVOFLOXACIN TABLETS 250 MG, 500 MG, AND 750 MG   ZYDUS PHARMACEUTICALS USA, INC. 4/20/2006 
11 76-287 FLUOXETINE CAPSULES USP, 10 MG AND 20 MG (RLD = SARAFEM CAPSULES/LILLY)   TEVA PHARMACEUTICALS USA 4/20/2006 
12 77-780 CARVEDILOL TABLETS 2.125 MG, 6.25 MG, 12.5 MG, AND 25 MG   TARO PHARMACEUTICAL INDUSTRIES, LTD. 4/21/2006 
13 76-311 TOPIRAMATE TABLETS 50 MG   PAR PHARMACEUTICAL 4/24/2006 
14 76-341 PRAVASTATIN SODIUM TABLETS 80 MG   APOTEX INC. 4/25/2006 
15 77-245 CIPROFLOXACIN INJECTION USP, 200 MG/20 ML AND 400 MG/40 ML SINGLE-USE VIALS   HOSPIRA INC. 4/27/2006 

 

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