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U.S. Department of Health and Human Services

Drugs

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Tentative Approvals - November 2006

  ANDA Number Generic Drug Name Applicant Tentative Approval Date
1 77-472 CETIRIZINE HYDROCHLORIDE SYRUP, 5 MG/5 ML   RANBAXY INC. 11/1/2006 
2 76-601 CETIRIZINE HYDROCHLORIDE SYRUP, 5 MG/5 ML   TARO PHARMACEUTICAL INDUSTRIES, LTD. 11/3/2006 
3 78-119 ABACAVIR SULFATE TABLETS, 300 MG (BASE)   CIPLA LTD. 11/6/2006 
4 77-837 SIMVASTATIN TABLETS USP, 5 MG, 10 MG, 20 MG, 40 MG, 80 MG   ZYDUS PHARMACEUTICALS USA, INC. 11/6/2006 
5 77-243 OLANZAPINE ORALLY DISINTEGRATING TABLETS, 5 MG, 10 MG, 15 MG, AND 20 MG   BARR LABORATORIES, INC. 11/8/2006 
6 77-887 CARVEDILOL TABLETS, 3.125 MG, 6.25 MG, 12.5 MG, AND 25 MG   HIKMA PHARMACEUTICALS 11/14/2006 
7 77-491 PRAVASTATIN SODIUM TABLETS, 80 MG   LEK PHARMACEUTICALS d.d. 11/14/2006 
8 77-256 TRANDOLAPRIL TABLET, 1 MG, 2 MG, AND 4 MG   COREPHARMA, LLC 11/20/2006 
9 77-766 SIMVASTATIN TABLETS USP, 5 MG, 10 MG, 20 MG, 40 MG, AND 80 MG   SANDOZ INC. 11/21/2006 
10 77-730 PRAVASTATIN SODIUM TABLETS, 80 MG   PLIVA HRVATSKA, d.o.o. 11/21/2006 
11 77-406 ONDANSETRON ORALLY DISINTEGRATING TABLETS USP, 16 MG AND 24 MG   KALI LABORATORIES, INC. 11/27/2006 
12 77251 FINASTERIDE TABLETS USP, 5 MG   GEDEON RICHTER LTD. 11/27/2006 
13 77-600 DICLOFENAC SODIUM OPHTHALMIC SOLUTION, 0.1%   APOTEX INC. 11/28/2006 
14 77-718 POLYETHYLENE GLYCOL 3350 NF POWDER FOR ORAL SOLUTION, 17 GRAMS/SCOOPFUL   PENTECH PHARMACEUTICALS, INC. 11/28/2006 
15 77-343 ONDANSETRON INJECTION USP, (PRESERVATIVE-FREE) 2 MG/ML; 2 ML VIALS   APOTEX INC. 11/28/2006 
16 77-544 ONDANSETRON INJECTION USP, 2 MG/ML; 20 ML VIALS   PLIVA HRVATSKA d.o.o. 11/28/2006 
17 76-840 SUMATRIPTAN SUCCINATE TABLETS, 25 MG (BASE), 50 MG (BASE), AND 100 MG (BASE)   TEVA PHARMACEUTICALS USA 11/28/2006 
18 77-845 DICLOFENAC SODIUM OPHTHALMIC SOLUTION, 0.1%   AKORN INC. 11/29/2006 
19 78-053 SERTRALINE HYDROCHLORIDE ORAL CONCENTRATE, 20 MG (BASE)/ML   RANBAXY INC. 11/30/2006 
20 77-368 ONDANSETRON INJECTION USP, 2 MG/ML; 20 ML VIALS   APOTEX INC. 11/30/2006 
21 77-752 SIMVASTATIN TABLETS USP, 10 MG, 20 MG, 40 MG, AND 80 MG   DR. REDDY'S LABORATORIES LIMITED 11/30/2006 
22 77-437 MOXIFLOXACIN HYDROCHLORIDE TABLETS, 400 MG   TEVA PHARMACEUTICALS USA 11/30/2006 

 

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