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U.S. Department of Health and Human Services

Drugs

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Tentative Approvals - August 2006

  ANDA Number Generic Drug Name Applicant Tentative Approval Date
1 77-416 RISPERIDONE ORAL SOLUTION 1 MG/ML   RANBAXY LABORATORIES LIMITED 8/3/2006 
2 77-463 NATEGLINIDE TABLETS 60 MG AND 120 MG   PAR PHARMACEUTICAL, INC. 8/10/2006 
3 78-195 NEVIRAPINE TABLETS 200 MG   STRIDES ACROLAB LTD. 8/11/2006 
4 77-166 VENLAFAXINE HYDROCHLORIDE TABLETS 25 MG (BASE), 37.5 MG (BASE), 50 MG (BASE), 75 MG (BASE), AND 100 MG (BASE)   MYLAN PHARMACEUTICALS INC. 8/14/2006 
5 77-732 LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE TABLETS 50 MG/12.5 MG AND 100 MG/25 MG   ROXANE LABORATORIES, INC. 8/16/2006 
6 78-045 FLUOXETINE CAPSULES USP, 10 MG AND 20 MG (RLD=SARAFEM CAPSULES/LILLY)   MYLAN PHARMACEUTICALS, INC. 8/25/2006 
7 77-753 CIPROFLOXACIN AND DEXTROSE (5%) INJECTION USP, 2 MG/ML; PACKAGED IN 200 MG/100 ML AND 400 MG/200 ML SINGLE-USE FLEXIBLE CONTAINERS   HOSPIRA INC. 8/28/2006 
8 78-256 STAVUDINE CAPSULES USP, 30 MG AND 40 MG   STRIDES ACROLAB LIMITED 8/28/2006 
9 77-713 SERTRALINE HYDROCHLORIDE TABLETS 25 MG (BASE), 50 MG (BASE), AND 100 MG (BASE)   SANDOZ INC. 8/29/2006 
10 77-480 ONDANSETRON AND 5% DEXTROSE INJECTION 0.64 MG/ML, PACKAGED IN 32 MG/50 ML FLEXIBLE PLASTIC CONTAINERS   SICOR PHARMACEUTICALS, INC. 8/30/2006 
11 77-763 CLOBETASOL PROPIONATE TOPICAL FOAM 0.05%   PERRIGO ISRAEL PHARMACEUTICAL LTD. 8/30/2006 
12 77-773 ZOLPIDEM TARTRATE TABLETS 5 MG AND 10 MG   WATSON LABORATORIES, INC. 8/31/2006 

 

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