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U.S. Department of Health and Human Services

Drugs

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Approvals - October 2006

  ANDA Number Generic Drug Name Applicant Approval Date
1 78-008 MELOXICAM TABLETS, 7.5 MG AND 15 MG AUROBINDO PHARMA LIMITED 10/2/2006
2 77-534 CITALOPRAM HYDROBROMIDE TABLETS, 10 MG (BASE), 20 MG (BASE), AND 40 MG (BASE) INVAGEN PHARMACEUTICALS, INC. 10/3/2006
3 77-743 RIBAVIRIN TABLETS, 200 MG SANDOZ INC. 10/3/2006
4 77-894 GABAPENTIN TABLETS, 100 MG, 300 MG, AND 400 MG APOTEX INC. 10/10/2006
5 77-824 RANITIDINE TABLETS USP, 150 MG AND 300 MG INTERPHARM INC. 10/13/2006
6 77-960 VALPROIC ACID SYRUP (VALPROIC ACID ORAL SOLUTION, USP), 250 MG/5 ML VINTAGE PHARMACEUTICALS, LLC 10/13/2006
7 65-307 CEFADROXIL FOR ORAL SUSPENSION USP, 250 MG/5 ML AND 500 MG/5 ML ORCHID HEALTHCARE 10/16/2006
8 77-625 ZONISAMIDE CAPSULES, 25 MG, 50 MG, AND 100 MG ZYDUS PHARMACEUTICALS USA,INC. 10/16/2006
9 76-341 PRAVASTATIN SODIUM TALBETS, 10 MG, 20 MG, AND 40 MG APOTEX INC. 10/23/2006
10 76-397 PRAVASTATIN SODIUM TABLETS, 10 MG, 20 MG, AND 40 MG LEK PHARMACEUTICALS d.d. 10/23/2006
11 76-714 PRAVASTATIN SODIUM TABLETS, 10 MG, 20 MG, AND 40 MG DR. REDDY'S LABORATORIES LIMITED 10/23/2006
12 76-939 PRAVASTATIN SODIUM TABLETS, 10 MG, 20 MG, AND 40 MG COBALT PHARMACEUTICALS, INC. 10/23/2006
13 77-013 PRAVASTATIN SODIUM TABLETS, 10 MG, 20 MG, AND 40 MG GENPHARM INC. 10/23/2006
14 77-904 PRAVASTATIN SODIUM TABLETS, 10 MG, 20 MG, AND 40 MG WATSON LABORATORIES, INC. 10/23/2006
15 77-510 COLESTIPOL HYDROCHLORIDE TABLETS, 1 G IMPAX LABORATORIES, INC. 10/24/2006
16 40-603 PROMETHAZINE HYDROCHLORIDE SUPPOSITORIES USP, 12.5 MG AND 25 MG TARO PHARMACEUTICALS U.S.A., INC. 10/26/2006
17 40-620 METHYLPREDNISOLONE ACETATE INJECTABLE SUSPENSION USP, 40 MG/ML AND 80 MG/ML SICOR PHARMACEUTICALS, INC. 10/27/2006
18 78-325 NICOTINE POLACRILEX GEM USP, (MINT FLAVOR) OTC 2 MG (BASE)/PIECE PERRIGO R&D COMPANY 10/30/2006
19 78-326 NICOTINE POLACRILEX GUM USP, (MINT-FLAVOR) OTC 4 MG (BASE)/PIECE PERRIGO R&D COMPANY 10/30/2006
20 77-190 MILRINONE LACTATE INJECTION, 1 MG (BASE)/ML; 5 ML SYRINGE GLAND PHARMA LIMITED 10/31/2006
21 77-264 METRONIDAZOLE VAGINAL GEL, 0.75% QLT USA, INC. 10/31/2006

 

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