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U.S. Department of Health and Human Services

Drugs

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Approvals - October 2006

 ANDA NumberGeneric Drug NameApplicantApproval Date
178-008MELOXICAM TABLETS, 7.5 MG AND 15 MGAUROBINDO PHARMA LIMITED10/2/2006
277-534CITALOPRAM HYDROBROMIDE TABLETS, 10 MG (BASE), 20 MG (BASE), AND 40 MG (BASE)INVAGEN PHARMACEUTICALS, INC.10/3/2006
377-743RIBAVIRIN TABLETS, 200 MGSANDOZ INC.10/3/2006
477-894GABAPENTIN TABLETS, 100 MG, 300 MG, AND 400 MGAPOTEX INC.10/10/2006
577-824RANITIDINE TABLETS USP, 150 MG AND 300 MGINTERPHARM INC.10/13/2006
677-960VALPROIC ACID SYRUP (VALPROIC ACID ORAL SOLUTION, USP), 250 MG/5 MLVINTAGE PHARMACEUTICALS, LLC10/13/2006
765-307CEFADROXIL FOR ORAL SUSPENSION USP, 250 MG/5 ML AND 500 MG/5 MLORCHID HEALTHCARE10/16/2006
877-625ZONISAMIDE CAPSULES, 25 MG, 50 MG, AND 100 MGZYDUS PHARMACEUTICALS USA,INC.10/16/2006
976-341PRAVASTATIN SODIUM TALBETS, 10 MG, 20 MG, AND 40 MGAPOTEX INC.10/23/2006
1076-397PRAVASTATIN SODIUM TABLETS, 10 MG, 20 MG, AND 40 MGLEK PHARMACEUTICALS d.d.10/23/2006
1176-714PRAVASTATIN SODIUM TABLETS, 10 MG, 20 MG, AND 40 MGDR. REDDY'S LABORATORIES LIMITED10/23/2006
1276-939PRAVASTATIN SODIUM TABLETS, 10 MG, 20 MG, AND 40 MGCOBALT PHARMACEUTICALS, INC.10/23/2006
1377-013PRAVASTATIN SODIUM TABLETS, 10 MG, 20 MG, AND 40 MGGENPHARM INC.10/23/2006
1477-904PRAVASTATIN SODIUM TABLETS, 10 MG, 20 MG, AND 40 MGWATSON LABORATORIES, INC.10/23/2006
1577-510COLESTIPOL HYDROCHLORIDE TABLETS, 1 GIMPAX LABORATORIES, INC.10/24/2006
1640-603PROMETHAZINE HYDROCHLORIDE SUPPOSITORIES USP, 12.5 MG AND 25 MGTARO PHARMACEUTICALS U.S.A., INC.10/26/2006
1740-620METHYLPREDNISOLONE ACETATE INJECTABLE SUSPENSION USP, 40 MG/ML AND 80 MG/MLSICOR PHARMACEUTICALS, INC.10/27/2006
1878-325NICOTINE POLACRILEX GEM USP, (MINT FLAVOR) OTC 2 MG (BASE)/PIECEPERRIGO R&D COMPANY10/30/2006
1978-326NICOTINE POLACRILEX GUM USP, (MINT-FLAVOR) OTC 4 MG (BASE)/PIECEPERRIGO R&D COMPANY10/30/2006
2077-190MILRINONE LACTATE INJECTION, 1 MG (BASE)/ML; 5 ML SYRINGEGLAND PHARMA LIMITED10/31/2006
2177-264METRONIDAZOLE VAGINAL GEL, 0.75%QLT USA, INC.10/31/2006