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U.S. Department of Health and Human Services

Drugs

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Approvals - November 2005

  ANDA Number Generic Drug Name Applicant Approval Date
1 77-070 SOTALOL HYDROCHLORIDE TABLETS USP (AF), 80 MG, 120 MG, AND 160 MG   GENPHARM INC. 11/4/2005 
2 77-310 CILOSTAZOL TABLETS, 50 MG   SANDOZ INC. 11/8/2005 
3 65-256 AMOXICILLIN TABLETS USP, 500 MG AND 875 MG   AUROBINDO PHARMA LIMITED 11/9/2005 
4 65-271 AMOXICILLIN CAPSULES USP, 250 MG AND 500 MG   AUROBINDO PHARMA LIMITED 11/9/2005 
5 77-293 FUROSEMIDE TABLETS USP, 20 MG, 40 MG, AND 80 MG   EXCELLIUM PHARMACEUTICAL, INC. 11/9/2005 
6 77-311 HYDROMORPHONE HYDROCHLORIDE TABLETS USP, 2 MG, 4 MG, AND 8 MG   KV PHARMACEUTICAL COMPANY 11/9/2005 
7 77-394 SODIUM BICARBONATE INJECTION USP, 7.5% (0.9 mEq/ML) AND 8.4% (1 mEq/ML) SYRINGES   HOSPIRA, INC. 11/9/2005 
8 65-277 DOXYCYCLINE HYCLATE TABLETS USP, 20 MG (BASE)   LANNETT HOLDINGS, INC. 11/10/2005 
9 65-150 AZITHROMYCIN TABLETS, 600 MG   TEVA PHARMACEUTICALS USA 11/14/2005 
10 65-153 AZITHROMYCIN TABLETS, 250 MG   TEVA PHARMACEUTICALS USA 11/14/2005 
11 65-193 AZITHROMYCIN TABLETS, 500 MG   TEVA PHARMACEUTICALS USA 11/14/2005 
12 65-209 AZITHROMYCIN TABLETS, 600 MG   SANDOZ, INC. 11/14/2005 
13 65-211 AZITHROMYCIN TABLETS, 250 MG   SANDOZ, INC. 11/14/2005 
14 65-212 AZITHROMYCIN TABLETS, 500 MG   SANDOZ, INC. 11/14/2005 
15 65-218 AZITHROMYCIN TABLETS, 600 MG   PLIVA HRVATSKA D.O.O. 11/14/2005 
16 65-223 AZITHROMYCIN TABLETS, 500 MG   PLIVA HRVATSKA D.O.O. 11/14/2005 
17 65-225 AZITHROMYCIN TABLETS, 250 MG   PLIVA HRVATSKA D.O.O. 11/14/2005 
18 65-235 CEFPROZIL TABLETS USP, 250 MG AND 500 MG   SANDOZ INC. 11/14/2005 
19 77-601 CITALOPRAM HYDROBROMIDE ORAL SOLUTION, 10 MG (BASE)/5 ML   APOTEX INC. 11/15/2005 
20 65-253 CEPHALEXIN CAPSULES USP, 250 MG AND 500 MG   AUROBINDO PHARMA LIMITED 11/16/2005 
21 40-596 PROMETHAZINE HYDROCHLORIDE TABLETS USP, 12.5 MG, 25 MG, AND 50 MG   ZYDUS PHARMACEUTICALS USA, INC. 11/18/2005 
22 76-527 OFLOXACIN OTIC SOLUTION, 0.3%   APOTEX INC. 11/18/2005 
23 75-959 OCTREOTIDE ACETATE INJECTION, 0.2 MG(BASE)/ML AND 1 MG (BASE)/ML; 5 ML VIALS   SICOR PHARMACEUTICALS, INC. 11/21/2005 
24 77-127 NIFEDIPINE EXTENDED-RELEASE TABLETS USP, 30 MG AND 60 MG   OSMOTICA PHARMACEUTICAL CORPORATION 11/21/2005 
25 65-188 AMPICILLIN AND SULBACTAM FOR INJECTION USP, 10 G(BASE)/5 G(BASE) PER VIAL; 15 G   G.C. HANFORD MANUFACTURING COMPANY 11/25/2005 
26 65-229 CEPHALEXIN CAPSULES USP, 250 MG AND 500 MG   LUPIN LIMITED 11/25/2005 
27 76-496 METFORMIN HYDROCHLORIDE EXTENDED-RELEASE TABLETS, 500 MG   BARR LABORATORIES, INC. 11/25/2005 
28 77-624 GLIMEPIRIDE TABLETS 1 MG, 2 MG, AND 4 MG   MYLAN PHARMACEUTICALS, INC. 11/28/2005 
29 65-222 AMPICILLIN AND SULBACTAM FOR INJECTION USP, 1 G(BASE)/500 MG(BASE) PER VIAL, AND 2 G(BASE)/1 G(BASE) PER VIAL   INSTITUTO BIOCHIMICO ITALIANO, S.P.A. 11/29/2005 
30 76-434 CHLORHEXIDINE GLUCONATE ORAL RINSE USP, 0.12%   JOHN O. BUTLER COMPANY 11/29/2005 
31 65-176 AMPICILLIN AND SULBACTAM FOR INJECTION USP, 1 G(BASE)/500 MG(BASE) PER VIAL & PIGGYBACK BOTTLE; 2 G(BASE)/1 G(BASE) PER VIAL & PIGGYBACK BOTTLE   G.C. HANFORD MANUFACTURING COMPANY 11/30/2005 
32 65-192 MUPIROCIN OINTMENT USP, 2%   ALTANA INC. 11/30/2005 
33 76-835 FLAVOXATE HYDROCHLORIDE TABLETS, 100 MG   HAMPTON LAINE, LLC 11/30/2005 
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