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U.S. Department of Health and Human Services

Drugs

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Approvals - December 2006

  ANDA Number Generic Drug Name Applicant Approval Date
1 76-761 OXANDROLONE TABLETS USP, 2.5 MG UPSHER-SMITH LABORATORIES, INC. 12/1/2006 
2 76-897 OXANDROLONE TABLETS USP, 2.5 MG 10 MG SANDOZ INC. 12/1/2006 
3 77-395 PAROXETINE HYDROCHLORIDE ORAL SUSPENSION, 10 MG/5 ML APOTEX INC. 12/4/2006 
4 40-654 PROMETHAZINE HCL AND PHENYLEPHRINE HCL ORAL SOLUTION, 6.25 MG/5 MG PER 5 ML VINTAGE PHARMACEUTICALS, LLC 12/7/2006 
5 40-660 PROMETHAZINE, PHENYLEPHRINE, CODEINE ORAL SOLUTION, 6.25 MG/5 MG/10 MG PER 5 ML VINTAGE PHARMACEUTICALS, LLC 12/7/2006 
6 77-918 MELOXICAM TABLETS, 7.5 MG 15 MG CARLSBAD TECHNOLOGY INC. 12/7/2006 
7 40-621 EXTENDED PHENYTOIN SODIUM CAPSULES USP, 100 MG SUN PHARMACEUTICAL INDUSTRIES LTD 12/11/2006 
8 40-652 TESTOSTERONE CYPIONATE INJECTION USP, 200 MG/ML SYNERX PHARMA, LLC 12/11/2006 
9 77-489 TRANDOLAPRIL TABLETS, 1 MG, 2 MG, AND 4 MG TEVA PHARMACEUTICALS USA 12/12/2006 
10 77-992 AMANTADINE HYDROCHLORIDE ORAL SOLUTION USP, 50 MG/5 ML VINTAGE PHARMACEUTICALS 12/12/2006 
11 40-672 TRIAMCINOLONE ACETONIDE LOTION USP, 0.1% VINTAGE PHARMACEUTICALS, LLC 12/13/2006 
12 65-198 CEFPROZIL TABLETS USP, 250 MG AND 500 MG RANBAXY LABORATORIES LIMITED 12/13/2006 
13 77-396 LORAZEPAM TABLETS USP, 0.5 MG, 1 MG, AND 2 MG IVAX PHARMACEUTICALS INC. 12/13/2006 
14 77-689 CIPROFLOXACIN OPHTHALMIC SOLUTION USP, 0.3% NEXUS PHARMACEUTICALS, INC. 12/13/2006 
15 77-899 NIFEDIPINE EXTENDED-RELEASE TABLETS USP, 30 MG AND 60 MG ABRIKA PHARMACEUTICALS, INC. 12/13/2006 
16 65-275 IDARUBICIN HYDROCHLORIDE INJECTION, 1 MG/ML; 5 ML, 10 ML, AND 20 ML VIALS BEDFORD LABORATORIES 12/14/2006 
17 77-284 BUPROPION HYDROCHLORIDE EXTENDED-RELEASE TABLETS USP, 150 MG AND 300 MG (ONCE-A-DAY) ANCHEN PHARMACEUTICALS, INC. 12/14/2006 
18 78-039 MELOXICAM TABLETS, 7.5 MG AND 15 MG RANBAXY LABORATORIES LTD. 12/14/2006 
19 76-511 FINASTERIDE TABLETS USP, 5 MG TEVA PHARMACEUTICALS, USA 12/15/2006 
20 77-415 BUPROPION HCL EXTENDED-RELEASE TABLETS USP, 300 MG IMPAX LABORATORIES, INC. 12/15/2006 
21 77-676 CICLOPIROX TOPICAL SUSPENSION USP, 0.77% PERRIGO NEW YORK, INC. 12/15/2006 
22 76-918 FLUCONAZOLE FOR ORAL SUSPENSION, 10 MG/ML AND 40 MG/ML TARO PHARMACEUTICAL INDUSTRIES LTD. 12/18/2006 
23 77-578 FINASTERIDE TABLETS USP, 5 MG MYLAN PHARMACEUTICALS, INC. 12/18/2006 
24 76-685 SIMVASTATIN TABLETS USP, 5 MG, 10 MG, 20 MG, 40 MG, AND 80 MG COBALT PHARMACEUTICALS, INC. 12/20/2006 
25 77-691 SIMVASTATIN TABLETS USP, 5 MG, 10 MG, 20 MG, 40 MG, AND 80 MG AUROBINDO PHARMA LIMITED 12/20/2006 
26 77-752 SIMVASTATIN TABLETS USP, 10 MG, 20 MG, 40 MG, AND 80 MG DR. REDDY'S LABORATORIES LIMITED 12/20/2006 
27 77-766 SIMVASTATIN TABLETS USP, 5 MG, 10 MG, 20 MG, 40 MG, AND 80 MG SANDOZ INC. 12/20/2006 
28 77-837 SIMVASTATIN TABLETS USP, 5 MG, 10 MG, 20 MG, 40 MG, AND 80 MG ZYDUS PHARMACEUTICALS USA, INC. 12/20/2006 
29 77-927 MELOXICAM TABLETS, 7.5 MG AND 15 MG UNICHEM LABORATORIES LIMITED 12/20/2006 
30 78-034 SIMVASTATIN TABLETS USP, 5 MG, 10 MG, 20 MG, 40 MG, AND 80 MG PERRIGO R & D COMPANY 12/20/2006 
31 76-867 ALBUTEROL SULFATE & IPRATROPIUM BROMIDE INHALATION SOLUTION, 3 MG (0.083%) AND 0.5 MG (0.017%); 3 ML VIALS SANDOZ INC. 12/21/2006 
32 77-251 FINASTERIDE TABLETS USP, 5 MG GEDEON RICHTER LTD. 12/22/2006 
33 76-183 ONDANSETRON HYDROCHLORIDE TABLETS, 4 MG (BASE), 8 MG (BASE), AND 24 MG (BASE) DR. REDDY'S LABORATORIES LIMITED 12/26/2006 
34 76-506 ONDANSETRON ORALLY DISINTEGRATING TABLETS USP, 4 MG AND 8 MG KALI LABORATORIES, INC. 12/26/2006 
35 76-559 ONDANSETRON HYDROCHLORIDE TABLETS, 16 MG (BASE) DR. REDDY'S LABORATORIES LIMITED 12/26/2006 
36 76-695 ONDANSETRON INJECTION USP, 2 MG/ML; 20 ML VIALS MAYNE PHARMA (USA), INC. 12/26/2006 
37 76-696 ONDANSETRON INJECTION USP, (PRESERVATIVE-FREE) 2 MG/ML; 2 ML VIALS MAYNE PHARMA (USA), INC. 12/26/2006 
38 76-780 ONDANSETRON INJECTION USP, (PRESERVATIVE-FREE) 2 MG/ML; 2 ML VIALS HIKMA FARMACEUTICA (PORTUGAL), S.A. 12/26/2006 
39 76-781 ONDANSETRON INJECTION USP, 2 MG/ML; 20 ML VIALS HIKMA FARMACEUTICA (PORTUGAL), S.A. 12/26/2006 
40 76-960 ONDANSETRON ORAL SOLUTION USP, 4 MG/5 ML ROXANE LABORATORIES, INC. 12/26/2006 
41 76-967 ONDANSETRON INJECTION USP, 2 MG/ML; 20 ML VIALS BEDFORD LABORATORIES 12/26/2006 
42 76-972 ONDANSETRON INJECTION USP, (PRESERVATIVE-FREE) 2 MG/ML; 2 ML VIALS ABRAXIX PHARMACEUTICAL PRODUCTS 12/26/2006 
43 76-974 ONDANSETRON INJECTION USP, 2 MG/ML; 20 ML VIALS ABRAXIS PHARMACEUTICAL PRODUCTS 12/26/2006 
44 77-011 ONDANSETRON INJECTION USP, (PRESERVATIVE-FREE) 2 MG/ML, 2ML VIALS BEDFORD LABORATORIES 12/26/2006 
45 77-172 ONDANSETRON INJECTION USP, 2 MG/ML; 20 ML VIALS SUN PHARMACEUTICAL INDUSTRIES, LTD. 12/26/2006 
46 77-173 ONDANSETRON INJECTION USP, (PRESERVATIVE-FREE) 2 MG/ML; 2 ML VIALS SUN PHARMACEUTICAL INDUSTRIES, LTD. 12/26/2006 
47 77-343 ONDANSETRON INJECTION USP, (PRESERVATIVE-FREE) 2 MG/ML; 2 ML VIALS APOTEX INC. 12/26/2006 
48 77-365 ONDANSETRON INJECTION USP, 2 MG/ML; 20 ML VIALS BAXTER HEALTHCARE CORPORATION 12/26/2006 
49 77-368 ONDANSETRON INJECTION USP, 2 MG/ML; 20 ML VIALS APOTEX INC. 12/26/2006 
50 77-387 ONDANSETRON INJECTION USP, (PRESERVATIVE-FREE) 2 MG/ML; 2 ML VIALS PHARMAFORCE, INC. 12/26/2006 
51 77-406 ONDANSETRON ORALLY DISINTEGRATING TABLETS USP, 16 MG AND 24 MG KALI LABORATORIES, INC. 12/26/2006 
52 77-473 ONDANSETRON INJECTION USP, 2 MG/ML; 20 ML VIALS HOSPIRA INC. 12/26/2006 
53 77-541 ONDANSETRON INJECTION USP, (PRESERVATIVE-FREE) 2 MG/ML; 2 ML VIALS BAXTER HEALTHCARE CORPORATION 12/26/2006 
54 77-544 ONDANSETRON INJECTION USP, 2 MG/ML; 20 ML VIALS PLIVA HRVATSKA d.o.o. 12/26/2006 
55 77-548 ONDANSETRON INJECTION USP, (PRESERVATIVE-FREE) 2 MG/ML 2 ML VIALS HOSPIRA INC. 12/26/2006 
56 77-577 ONDANSETRON INJECTION USP, 2 MG/ML; 20 ML VIALS WOCKHARDT LIMITED 12/26/2006 
57 77-582 ONDANSETRON INJECTION USP, 2 MG/ML; 20 ML VIALS PHARMAFORCE, INC. 12/26/2006 
58 77-716 ONDANSETRON INJECTION USP, (PRESERVATIVE-FREE) 2 MG/ML; 2 ML VIALS WOCKHARDT LIMITED 12/26/2006 
59 77-877 ATENOLOL TABLETS USP, 25 MG, 50 MG, AND 100 MG OHM LABORATORIES, INC. 12/27/2006 
60 77-910 BISOPROLOL FUMARATE TABLETS USP, 5 MG AND 10 MG AUROBINDO PHARMA LIMITED 12/27/2006 
61 78-105 ALBUTEROL SULFATE SYRUP, 2 MG (BASE)/5 ML VINTAGE PHARMACEUTICALS, LLC 12/27/2006 
62 40-624 METHSCOPOLAMINE BROMIDE TABLETS USP, 2.5 MG AND 5 MG BOCA PHARMACAL, INC. 12/28/2006 
63 65-334 AMOXICILLIN FOR ORAL SUSPENSION USP, 200 MG/5 ML AND 400 MG/5 ML AUROBINDO PHARMA LIMITED 12/28/2006 

 

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