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Approvals - October 2005

  ANDA Number Generic Drug Name Applicant Approval Date
1 75-957 OCTREOTIDE ACETATE INJECTION 0.05 MG (BASE)/ML, 0.1 MG(BASE)/ML, AND 0.5 MG (BASE)/ML   SICOR PHARMACEUTICALS, INC. 10/3/2005 
2 76-418 AMLODIPINE BESYLATE TABLETS 2.5 MG (BASE), 5 MG (BASE), AND 10 MG (BASE)   MYLAN PHARMACEUTICALS, INC. 10/3/2005 
3 77-209 CYCLOBENZAPRINE HYDROCHLORIDE TABLETS USP, 10 MG   AMIDE PHARMACEUTICAL, INC. 10/4/2005 
4 76-802 GLIMEPIRIDE TABLETS 1 MG, 2 MG, AND 4 MG   TEVA PHARMACEUTICALS USA 10/6/2005 
5 76-875 GLIMEPIRIDE TABLETS 1 MG, 2 MG, 4 MG, AND 8 MG   RANBAXY LABORATORIES, INC. 10/6/2005 
6 77-091 GLIMEPIRIDE TABLETS 1 MG, 2 MG, AND 4 MG   DR. REDDY'S LABORATORIES LIMITED 10/6/2005 
7 77-274 GLIMEPIRIDE TABLETS 1 MG, 2 MG, AND 4 MG   COREPHARMA LLC 10/6/2005 
8 77-295 GLIMEPIRIDE TABLETS 1 MG, 2 MG, AND 4 MG   INVAGEN PHARMACEUTICALS, INC. 10/6/2005 
9 77-366 GLIMEPIRIDE TABLETS 3 MG AND 6 MG   RANBAXY LABORATORIES LIMITED 10/6/2005 
10 76-606 GABAPENTIN CAPSULES 100 MG 300 MG 400 MG   RANBAXY LABORATORIES LIMITED 10/7/2005 
11 76-817 SULFAMETHOXAZOLE AND TRIMETHOPRIM TABLETS USP, 400 MG/80 MG AND 800 MG/160 MG   VISTA PHARMACEUTICALS, INC. 10/7/2005 
12 77-201 KETOROLAC TROMETHAMINE INJECTION USP, 30 MG/ML; PACKAGED IN 150 MG/5 ML MULTIPLE-DOSE VIALS   APOTEX INC. 10/14/2005 
13 77-220 PILOCARPINE HYDROCHLORIDE TABLETS 5 MG   LANNETT HOLDINGS, INC. 10/14/2005 
14 65-144 CLARITHROMYCIN TABLETS USP, 250 MG   SANDOZ INC. 10/18/2005 
15 76-723 HYDROMORPHONE HYDROCHLORIDE TABLETS USP, 8 MG   AMIDE PHARMACEUTICAL, INC. 10/18/2005 
16 76-549 RAMIPRIL CAPSULES 1.25 MG, 2.5 MG, 5 MG, AND 10 MG   COBALT PHARMACEUTICALS, INC. 10/24/2005 
17 76-686 DANTROLENE SODIUM CAPSULES 25 MG, 50 MG, AND 100 MG   AMIDE PHARMACEUTICAL, INC. 10/24/2005 
18 77-507 GLIPIZIDE AND METFORMIN HYDROCHLORIDE TABLETS 2.5 MG/250 MG, 2.5 MG/500 MG, AND 5 MG/500 MG   COREPHARMA LLC 10/27/2005 
19 65-187 NEOMYCIN & POLYMYXIN B SULFATES & GRAMICIDIN OPHTHALMIC SOL 1.75 MG(BASE)/10,0000 UNITS/0.025 MG PER ML   PHARMAFORCE, INC. 10/28/2005 
20 76-763 CLOTRIMAZOLE LOZENGES USP, 10 MG   PADDOCK LABORATORIES, INC. 10/28/2005 
21 77-224 RIBAVIRIN CAPSULES 200 MG   ZYDUS PHARMACEUTICALS USA INC. 10/28/2005 
22 77-270 GLIPIZIDE AND METFORMIN HYDROCHLORIDE TABLETS 2.5 MG/250 MG, 2.5 MG/500 MG, AND 5 MG/500 MG   TEVA PHARMACEUTICALS USA 10/28/2005 
23 65-216 NEOMYCIN & POLYMYXIN B SULFATES & HYDROCORTISONE OTIC SOL, U 3.5 MG (BASE)/10,000U/10 MG PER ML   PHARMAFORCE, INC. 10/31/2005 
24 76-635 FENOFIBRATE TABLETS 54 MG, 107 MG, AND 160 MG   RANBAXY LABORATORIES LIMITED 10/31/2005 
25 77-232 CITALOPRAM HYDROBROMIDE TABLETS 10 MG (BASE), 20 MG (BASE), AND 40 MG (BASE)   PLIVA HRVATSKA D.O.O. 10/31/2005

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Date created: November 3, 2005

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