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U.S. Department of Health and Human Services

Drugs

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Tentative Approvals - November 2006

 ANDA NumberGeneric Drug NameApplicantTentative Approval Date
177-472CETIRIZINE HYDROCHLORIDE SYRUP, 5 MG/5 ML  RANBAXY INC.11/1/2006 
276-601CETIRIZINE HYDROCHLORIDE SYRUP, 5 MG/5 ML  TARO PHARMACEUTICAL INDUSTRIES, LTD.11/3/2006 
378-119ABACAVIR SULFATE TABLETS, 300 MG (BASE)  CIPLA LTD.11/6/2006 
477-837SIMVASTATIN TABLETS USP, 5 MG, 10 MG, 20 MG, 40 MG, 80 MG  ZYDUS PHARMACEUTICALS USA, INC.11/6/2006 
577-243OLANZAPINE ORALLY DISINTEGRATING TABLETS, 5 MG, 10 MG, 15 MG, AND 20 MG  BARR LABORATORIES, INC.11/8/2006 
677-887CARVEDILOL TABLETS, 3.125 MG, 6.25 MG, 12.5 MG, AND 25 MG  HIKMA PHARMACEUTICALS11/14/2006 
777-491PRAVASTATIN SODIUM TABLETS, 80 MG  LEK PHARMACEUTICALS d.d.11/14/2006 
877-256TRANDOLAPRIL TABLET, 1 MG, 2 MG, AND 4 MG  COREPHARMA, LLC11/20/2006 
977-766SIMVASTATIN TABLETS USP, 5 MG, 10 MG, 20 MG, 40 MG, AND 80 MG  SANDOZ INC.11/21/2006 
1077-730PRAVASTATIN SODIUM TABLETS, 80 MG  PLIVA HRVATSKA, d.o.o.11/21/2006 
1177-406ONDANSETRON ORALLY DISINTEGRATING TABLETS USP, 16 MG AND 24 MG  KALI LABORATORIES, INC.11/27/2006 
1277251FINASTERIDE TABLETS USP, 5 MG  GEDEON RICHTER LTD.11/27/2006 
1377-600DICLOFENAC SODIUM OPHTHALMIC SOLUTION, 0.1%  APOTEX INC.11/28/2006 
1477-718POLYETHYLENE GLYCOL 3350 NF POWDER FOR ORAL SOLUTION, 17 GRAMS/SCOOPFUL  PENTECH PHARMACEUTICALS, INC.11/28/2006 
1577-343ONDANSETRON INJECTION USP, (PRESERVATIVE-FREE) 2 MG/ML; 2 ML VIALS  APOTEX INC.11/28/2006 
1677-544ONDANSETRON INJECTION USP, 2 MG/ML; 20 ML VIALS  PLIVA HRVATSKA d.o.o.11/28/2006 
1776-840SUMATRIPTAN SUCCINATE TABLETS, 25 MG (BASE), 50 MG (BASE), AND 100 MG (BASE)  TEVA PHARMACEUTICALS USA11/28/2006 
1877-845DICLOFENAC SODIUM OPHTHALMIC SOLUTION, 0.1%  AKORN INC.11/29/2006 
1978-053SERTRALINE HYDROCHLORIDE ORAL CONCENTRATE, 20 MG (BASE)/ML  RANBAXY INC.11/30/2006 
2077-368ONDANSETRON INJECTION USP, 2 MG/ML; 20 ML VIALS  APOTEX INC.11/30/2006 
2177-752SIMVASTATIN TABLETS USP, 10 MG, 20 MG, 40 MG, AND 80 MG  DR. REDDY'S LABORATORIES LIMITED11/30/2006 
2277-437MOXIFLOXACIN HYDROCHLORIDE TABLETS, 400 MG  TEVA PHARMACEUTICALS USA11/30/2006