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U.S. Department of Health and Human Services

Drugs

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Tentative Approvals - December 2005

  ANDA Number Generic Drug Name Applicant Tentative Approval Date
1 77-345 SERTRALINE HYDROCHLORIDE TABLETS, 25 MG (BASE), 50 MG (BASE), AND 100 MG (BASE)   PUREPAC PHARMACEUTICAL COMPANY 12/6/2005 
2 76-748 ROSIGLITAZONE MALEATE TABLETS, 2 MG (BASE), 4 MG (BASE), AND 8 MG (BASE)   DR. REDDY'S LABORATORIES LIMITED 12/7/2005 
3 77-129 RIVASTIGMINE TARTRATE CAPSULES, 1.5 MG (BASE), 3 MG (BASE), 4.5 MG (BASE), AND 6 MG (BASE)   WATSON LABORATORIES, INC. 12/7/2005 
4 77-376 MIRTAZAPINE ORALLY DISINTEGRATING TABLETS, 45 MG   AUROBINDO PHARMA LIMITED 12/8/2005 
5 76-798 PIOGLITAZONE HYDROCHLORIDE TABLETS, 15 MG (BASE), 30 MG (BASE), AND 45 MG (BASE)   WATSON LABORATORIES, INC. 12/13/2005 
6 77-136 TERBINAFINE HYDROCHLORIDE TABLETS, 250 MG (BASE)   GENPHARM INC. 12/13/2005 
7 76-596 MODAFINIL TABLETS, 100 MG AND 200 MG   TEVA PHARMACEUTICALS USA 12/16/2005 
8 77-299 SERTRALINE HYDROCHLORIDE TABLETS, 25 MG (BASE), 50 MG (BASE), AND 100 MG (BASE)   PLIVA HRVATSKA D.O.O. 12/21/2005 
9 77-363 RIVASTIGMINE TARTRATE ORAL SOLUTION, 2 MG (BASE)/ML   RANBAXY INC. 12/21/2005 
10 77-774 STAVUDINE FOR ORAL SOLUTION USP, 1 MG/ML   AUROBINDO PHARMA LIMITED 12/21/2005 
11 76-442 SERTRALINE HYDROCHLORIDE TABLETS, 25 MG (BASE), 50 MG (BASE), AND 100 MG (BASE)   DR. REDDY'S LABORATORIES LIMITED 12/27/2005 
12 77-221 LAMIVUDINE TABLETS, 150 MG AND 300 MG   WATSON LABORATORIES, INC. 12/27/2005 
13 77-378 CARVEDILOL TABLETS, 3.125 MG   CARACO PHARMACEUTICAL LABORATORIES, LTD. 12/27/2005 
14 77-702 NEVIRAPINE ORAL SUSPENSION, 50 MG/5 ML   AUROBINDO PHARMA LIMITED 12/29/2005 
15 77-335 FINASTERIDE TABLETS USP, 1 MG   WATSON LABORATORIES, INC. 12/29/2005 
16 76-532 SIMVASTATIN TABLETS USP, 5 MG, 10 MG, 20 MG, 40 MG, AND 80 MG   TEVA PHARMACEUTICALS USA 12/30/2005
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