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U.S. Department of Health and Human Services

Drugs

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Approvals - November 2006

  ANDA Number Generic Drug Name Applicant Approval Date
1 40-721 BETHANECHOL CHLORIDE TABLETS USP, 50 MG   IMPAX LABORATORIES, INC. 11/1/2006 
2 40-739 BETHANECHOL CHLORIDE TABLETS USP, 5 MG   IMPAX LABORATORIES, INC. 11/1/2006 
3 40-740 BETHANECHOL CHLORIDE TABLETS USP, 25 MG   IMPAX LABORATORIES, INC. 11/1/2006 
4 40-741 BETHANECHOL CHLORIDE TABLETS USP, 10 MG   IMPAX LABORATORIES, INC. 11/1/2006 
5 77-723 HYDROCODONE BITARTRATE AND IBUPROFEN TABLETS, 7.5 MG/200 MG AND 10 MG/200 MG   VINTAGE PHARMACEUTICALS, LLC 11/6/2006 
6 77-727 HYDROCODONE BITARTRATE AND IBUPROFEN TABLETS, 5 MG/200 MG   VINTAGE PHARMACEUTICALS, LLC 11/6/2006 
7 65-377 DOXYCYCLINE TABLETS, 50 MG, 75 MG, AND 100 MG   MYLAN PHARMACEUTICALS, INC. 11/7/2006 
8 78-102 MELOXICAM TABLETS, 7.5 MG AND 15 MG   TARO PHARMACEUTICAL INDUSTRIES, LTD. 11/7/2006 
9 40-593 PROMETHAZINE HYDROCHLORIDE INJECTION USP, 25 MG/ML AND 50 MG/ML; 1 ML AMPULES   SANDOZ CANADA, INC. 11/8/2006 
10 76-644 OXYBUTYNIN CHLORIDE EXTENDED-RELEASE TABLETS, 10 MG   MYLAN PHARMACEUTICALS, INC. 11/9/2006 
11 76-702 OXYBUTYNIN CHLORIDE EXTENDED-RELEASE TABLETS, 5 MG   MYLAN PHARMACEUTICALS INC. 11/9/2006 
12 76-745 OXYBUTYNIN CHLORIDE EXTENDED-RELEASE TABLETS, 15 MG   IMPAX LABORATORIES, INC. 11/9/2006 
13 77-698 THALLOUS CHLORIDE Tl-201 INJECTION USP, 2 mCi/mL   TCI MEDICAL, INC. 11/9/2006 
14 77-612 SULFAMETHOXAZOLE AND TRIMETHOPRIM ORAL SUSPENSION USP, 200 MG/40 MG PER 5 ML   TEVA PHARMACEUTICALS USA 11/13/2006 
15 77-015 SULFACETAMIDE SODIUM TOPICAL SUSPENSION USP, 10%   ALTANA INC. 11/17/2006 
16 77-730 PRAVASTATIN SODIUM TABLETS, 10 MG, 20 MG, 30 MG, AND 40 MG   PLIVA HRVATSKA d.o.o. 11/21/2006 
17 76-759 ONDANSETRON INJECTION USP, 2 MG/ML (PRESERVATIVE-FREE); 2ML VIALS   TEVA PHARMACEUTICALS USA 11/22/2006 
18 76-876 ONDANSETRON INJECTION USP, 2 MG/ML; 40 ML VIALS   TEVA PHARMACEUTICALS USA 11/22/2006 
19 77-480 ONDANSETRON AND DEXTROSE INJECTION, 0.64 MG/ML, 50 ML FLEXIBLE PLASTIC CONTAINERS   SICOR PHARMACEUTICALS, INC. 11/22/2006 
20 65-314 AMPICILLIN AND SULBACTAM FOR INJECTION USP, 10 GRAMS (BASE)/5 GRAMS (BASE) 15 GM PHARMACY BULK PACKAGE   INSTITUTO BIOCHIMICO ITALIANO, S.P.A. 11/27/2006 
21 65-353 DOXYCYCLINE TABLETS, 50 MG, 75 MG, AND 100 MG   SANDOZ INC. 11/27/2006 
22 77-574 PACLITAXEL INJECTION USP, 6 MG/ML; 5 ML, 16.7 ML, AND 50 ML VIALS   DABUR ONCOLOGY PLC 11/27/2006 
23 65-141 CEFAZOLIN FOR INJECTION USP, (PHARMACY BULK PACKAGE) 100 G AND 300 G   SAMSON MEDICAL TECHNOLOGIES, L.L.C. 11/29/2006 
24 77-289 CITALOPRAM HYDROBROMIDE TABLETS, 10 MG (BASE), 20 MG (BASE) AND 40 MG (BASE)   INTERPHARM INC. 11/30/2006 
25 77-536 MOEXIPRIL HYDROCHLORIDE TABLETS, 7.5 MG AND 15 MG   PADDOCK LABORATORIES, INC. 11/30/2006 
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