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U.S. Department of Health and Human Services

Drugs

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Tentative Approvals - July 2006

 ANDA NumberGeneric Drug NameApplicantTentative Approval Date
177-112ONDANSETRON HYDROCHLORIDE TABLETS, 4 MG (BASE), 8 MG (BASE), AND 24 MG (BASE)  PLIVA HRVATSKA D.O.O.7/5/2006 
277-275DIDANOSINE TABELTS, 100 MG, 150 MG, AND 200 MG  AUROBINDO PHARMA LIMITED INC.7/10/2006 
377-375AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE CAPSULES, 2.5 MG(BASE)/10 MG, 5 MG(BASE)/10 MG, 5 MG(BASE)/20 MG, AND 10 MG(BASE)/20 MG  MYLAN PHARMACEUTICALS, INC.7/11/2006 
477-179AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE CAPSULES, 2.5 MG(BASE)/10 MG, 5 MG(BASE)/10 MG, 5 MG (BASE)/20 MG, AND 10 MG (BASE)/20 MG  TEVA PHARMACEUTICALS, USA7/11/2006 
577-469FLUOXETINE CAPSULES USP, 10 MG AND 20 MG  SANDOZ INC.7/14/2006 
677-818SERTRALINE HYDROCHLORIDE TABLETS, 25 MG (BASE), 50 MG (BASE), AND 100 MG (BASE)  MUTUAL PHARMACEUTICAL COMPANY, INC.7/14/2006 
777-557ONDANSETRON ORALLY DISINTEGRATING TABLETS, 4 MG AND 8 MG  SUN PHARMACEUTICAL INDUSTRIES LTD.7/17/2006 
877-288ZOLPIDEM TARTRATE TABLETS, 5 MG AND 10 MG  MUTUAL PHARMACEUTICAL COMPANY, INC.7/17/2006 
977-412ESCITALOPRAM OXALATE TABLETS, 5 MG, 10 MG, AND 20 MG  TEVA PHARMACEUTICALS USA7/26/2006 
1077-238ZALEPLON CAPSULES, 5 MG AND 10 MG  GENPHARM INC.7/26/2006 
1177-533TERBINAFINE HYDROCHLORIDE TABLETS, 250 MG (BASE)  INVAGEN PHARMACEUTICALS, INC.7/28/2006 
1276-969METOPROLOL SUCCINATE EXTENDED- RELEASE TABLETS, USP 50 MG, 100 MG, AND 200 MG  SANDOZ INC.7/31/2006 
1377-582ONDANSETRON INJECTION USP, 2 MG/ML, PACKAGED IN 40 MG/20 ML MULTIPLE-DOSE VIALS  PHARMAFORCE, INC.7/31/2006