|
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 |