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U.S. Department of Health and Human Services

Drugs

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Tentative Approvals - June 2006

 ANDA NumberGeneric Drug NameApplicantTentative Approval Date
177-296DIVALPROEX SODIUM DELAYED-RELEASE TABLETS USP, 125 MG, 250 MG, AND 500 MG (VALPROIC ACID EQUIVALENT)  WOCKHARDT LIMITED6/5/2006 
277-431EXEMESTANE TABLETS, 25 MG  ROXANE LABORATORIES, INC.6/7/2006 
377-365ONDANSETRON INJECTION USP, 2 MG/ML; 40 ML MULTIPLE-DOSE VIALS  BAXTER HEALTHCARE CORPORATION6/9/2006 
477-541ONDANSETRON INJECTION USP, (PRESERVATIVE-FREE) 2 MG/ML; 2 ML SINGLE-DOSE VIALS  BAXTER HEALTHCARE CORPORATION6/9/2006 
577-254DIVALPROEX SODIUM DELAYED-RELEASE TABLETS USP, 125 MG, 250 MG, AND 500 MG (VALPROIC ACID EQUIVALENT)  GENPHARM INC.6/9/2006 
677-050ONDANSETRON HYDROCHLORIDE TABLETS, 4 MG (BASE) AND 8 MG (BASE)  SUN PHARMACEUTICAL INDUSTRIES, LTD.6/9/2006 
777-130RIVASTIGMINE TARTRATE CAPSULES, 3 MG (BASE), 4.5 MG (BASE), AND 6 MG (BASE)  DR. REDDY'S LABORATORIES LIMITED6/13/2006 
877-157LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE TABLETS, 50 MG/12.5 MG AND 100 MG/25 MG  TEVA PHARMACEUTICALS USA6/13/2006 
977-751PRAVASTATIN SODIUM TABLETS, 10 MG, 20 MG, 40 MG, AND 80 MG  ZYDUS PHARMACEUTICALS USA, INC.6/13/2006 
1077-473ONDANSETRON INJECTION USP, 2 MG/ML; 20 ML MULTIPLE-DOSE VIALS  HOSPIRA INC.6/15/2006 
1177-548ONDANSETRON INJECTION USP, (PRESERVATIVE-FREE) 2 MG/ML; 2 ML SINGLE-DOSE VIALS  HOSPIRA, INC.6/15/2006 
1276-630LAMOTRIGINE TABLETS, (CHEWABLE) 5 MG AND 25 MG  GENPHARM INC.6/19/2006 
1377-428LAMOTRIGINE TABLETS, 25 MG, 100 MG, 150 MG, AND 200 MG  GENPHARM INC.6/21/2006 
1477-392LAMOTRIGINE TABLETS, 25 MG, 100 MG, 150 MG, AND 200 MG  ROXANE LABORATORIES, INC.6/21/2006 
1577-058PANTOPRAZOLE SODIUM DELAYED-RELEASE TABLETS, 20 MG (BASE) AND 40 MG (BASE)  SUN PHARMACEUTICAL INDUSTRIES LTD.6/22/2006 
1677-980LAMIVUDINE ORAL SOLUTION, 10 MG/ML  CIPLA LIMITED6/22/2006 
1777-516AMLODIPINE BESYLATE TABLETS, 2.5 MG (BASE), 5 MG (BASE) AND 10 MG (BASE)  KALI LABORATORIES, INC.6/23/2006 
1877-950ABACAVIR SULFATE ORAL SOLUTION, 20 MG/ML  AUROBINDO PHARMA LIMITED INC.6/27/2006 
1977-672STAVUDINE CAPSULES USP, 15 MG AND 20 MG  AUROBINDO PHARMA LIMITED6/27/2006