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U.S. Department of Health and Human Services

Drugs

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Tentative Approvals - August 2006

 ANDA NumberGeneric Drug NameApplicantTentative Approval Date
177-416RISPERIDONE ORAL SOLUTION 1 MG/ML  RANBAXY LABORATORIES LIMITED8/3/2006 
277-463NATEGLINIDE TABLETS 60 MG AND 120 MG  PAR PHARMACEUTICAL, INC.8/10/2006 
378-195NEVIRAPINE TABLETS 200 MG  STRIDES ACROLAB LTD.8/11/2006 
477-166VENLAFAXINE 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 
577-732LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE TABLETS 50 MG/12.5 MG AND 100 MG/25 MG  ROXANE LABORATORIES, INC.8/16/2006 
678-045FLUOXETINE CAPSULES USP, 10 MG AND 20 MG (RLD=SARAFEM CAPSULES/LILLY)  MYLAN PHARMACEUTICALS, INC.8/25/2006 
777-753CIPROFLOXACIN 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 
878-256STAVUDINE CAPSULES USP, 30 MG AND 40 MG  STRIDES ACROLAB LIMITED8/28/2006 
977-713SERTRALINE HYDROCHLORIDE TABLETS 25 MG (BASE), 50 MG (BASE), AND 100 MG (BASE)  SANDOZ INC.8/29/2006 
1077-480ONDANSETRON AND 5% DEXTROSE INJECTION 0.64 MG/ML, PACKAGED IN 32 MG/50 ML FLEXIBLE PLASTIC CONTAINERS  SICOR PHARMACEUTICALS, INC.8/30/2006 
1177-763CLOBETASOL PROPIONATE TOPICAL FOAM 0.05%  PERRIGO ISRAEL PHARMACEUTICAL LTD.8/30/2006 
1277-773ZOLPIDEM TARTRATE TABLETS 5 MG AND 10 MG  WATSON LABORATORIES, INC.8/31/2006