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U.S. Department of Health and Human Services

Drugs

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Tentative Approvals - June 2006

  ANDA Number Generic Drug Name Applicant Tentative Approval Date
1 77-296 DIVALPROEX SODIUM DELAYED-RELEASE TABLETS USP, 125 MG, 250 MG, AND 500 MG (VALPROIC ACID EQUIVALENT)   WOCKHARDT LIMITED 6/5/2006 
2 77-431 EXEMESTANE TABLETS, 25 MG   ROXANE LABORATORIES, INC. 6/7/2006 
3 77-365 ONDANSETRON INJECTION USP, 2 MG/ML; 40 ML MULTIPLE-DOSE VIALS   BAXTER HEALTHCARE CORPORATION 6/9/2006 
4 77-541 ONDANSETRON INJECTION USP, (PRESERVATIVE-FREE) 2 MG/ML; 2 ML SINGLE-DOSE VIALS   BAXTER HEALTHCARE CORPORATION 6/9/2006 
5 77-254 DIVALPROEX SODIUM DELAYED-RELEASE TABLETS USP, 125 MG, 250 MG, AND 500 MG (VALPROIC ACID EQUIVALENT)   GENPHARM INC. 6/9/2006 
6 77-050 ONDANSETRON HYDROCHLORIDE TABLETS, 4 MG (BASE) AND 8 MG (BASE)   SUN PHARMACEUTICAL INDUSTRIES, LTD. 6/9/2006 
7 77-130 RIVASTIGMINE TARTRATE CAPSULES, 3 MG (BASE), 4.5 MG (BASE), AND 6 MG (BASE)   DR. REDDY'S LABORATORIES LIMITED 6/13/2006 
8 77-157 LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE TABLETS, 50 MG/12.5 MG AND 100 MG/25 MG   TEVA PHARMACEUTICALS USA 6/13/2006 
9 77-751 PRAVASTATIN SODIUM TABLETS, 10 MG, 20 MG, 40 MG, AND 80 MG   ZYDUS PHARMACEUTICALS USA, INC. 6/13/2006 
10 77-473 ONDANSETRON INJECTION USP, 2 MG/ML; 20 ML MULTIPLE-DOSE VIALS   HOSPIRA INC. 6/15/2006 
11 77-548 ONDANSETRON INJECTION USP, (PRESERVATIVE-FREE) 2 MG/ML; 2 ML SINGLE-DOSE VIALS   HOSPIRA, INC. 6/15/2006 
12 76-630 LAMOTRIGINE TABLETS, (CHEWABLE) 5 MG AND 25 MG   GENPHARM INC. 6/19/2006 
13 77-428 LAMOTRIGINE TABLETS, 25 MG, 100 MG, 150 MG, AND 200 MG   GENPHARM INC. 6/21/2006 
14 77-392 LAMOTRIGINE TABLETS, 25 MG, 100 MG, 150 MG, AND 200 MG   ROXANE LABORATORIES, INC. 6/21/2006 
15 77-058 PANTOPRAZOLE SODIUM DELAYED-RELEASE TABLETS, 20 MG (BASE) AND 40 MG (BASE)   SUN PHARMACEUTICAL INDUSTRIES LTD. 6/22/2006 
16 77-980 LAMIVUDINE ORAL SOLUTION, 10 MG/ML   CIPLA LIMITED 6/22/2006 
17 77-516 AMLODIPINE BESYLATE TABLETS, 2.5 MG (BASE), 5 MG (BASE) AND 10 MG (BASE)   KALI LABORATORIES, INC. 6/23/2006 
18 77-950 ABACAVIR SULFATE ORAL SOLUTION, 20 MG/ML   AUROBINDO PHARMA LIMITED INC. 6/27/2006 
19 77-672 STAVUDINE CAPSULES USP, 15 MG AND 20 MG   AUROBINDO PHARMA LIMITED 6/27/2006

 

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