|
ANDA Number |
Generic Drug Name |
Applicant |
Approval Date |
1 |
77-053 |
RIBAVIRIN TABLETS, 200 MG |
TEVA PHARMACEUTICALS, INC. |
12/5/2005 |
2 |
77-094 |
RIBAVIRIN TABLETS, 200 MG |
ZYDUS PHARMACEUTICALS USA, INC. |
12/5/2005 |
3 |
77-456 |
RIBAVIRIN TABLETS, 200 MG, 400 MG, AND
600 MG |
THREE RIVERS PHARMACEUTICALS, LLC |
12/5/2005 |
4 |
65-208 |
CEFPROZIL TABLETS USP, 250 MG AND 500 MG
|
TEVA PHARMACEUTICALS USA |
12/6/2005 |
5 |
76-446 |
OXYCODONE HYDROCHLORIDE EXTENDED-RELEASE
TABLETS, 10 MG, 20 MG, AND 40 MG |
IMPAX LABORATORIES, INC. |
12/6/2005 |
6 |
76-610 |
OXYCODONE HYDROCHLORIDE EXTENDED-RELEASE
TABLETS, 10 MG, 20 MG, AND 40 MG |
TEVA PHARMACEUTICALS, USA |
12/6/2005 |
7 |
77-272 |
CARBAMAZEPINE TABLETS USP, 100 MG, 200
MG, 300 MG, AND 400 MG |
CARACO PHARMACEUTICAL LABORATORIES, LTD. |
12/7/2005 |
8 |
65-236 |
CEFPROZIL FOR ORAL SUSPENSION USP, 125
MG/5 ML AND 250 MG/5 ML |
TEVA PHARMACEUTICALS USA |
12/8/2005 |
9 |
65-257 |
CEFPROZIL FOR ORAL SUSPENSION USP, 125
MG/5 ML AND 250 MG/5 ML |
SANDOZ INC. |
12/8/2005 |
10 |
65-276 |
CEFPROZIL TABLETS USP, 250 MG AND 500 MG
|
LUPIN LIMITED |
12/8/2005 |
11 |
65-285 |
DOXYCYCLINE TABLETS, 50 MG AND 100 MG |
LANNETT HOLDINGS, INC. |
12/8/2005 |
12 |
77-290 |
OXYCODONE HYDROCHLORIDE TABLETS USP, 5
MG, 10 MG, 15 MG, 20 MG, AND 30 MG |
KV PHARMACEUTICAL COMPANY |
12/8/2005 |
13 |
77-376 |
MIRTAZAPINE ORALLY DISINTEGRATING
TABLETS, 15 MG AND 30 MG |
AUROBINDO PHARMA LIMITED |
12/8/2005 |
14 |
65-179 |
AZITHROMYCIN FOR INJECTION, 500 MG/VIAL |
AMERICAN PHARMACEUTICAL PARTNERS, INC. |
12/13/2005 |
15 |
75-831 |
BISOPROLOL FUMARATE TABLETS, 5 MG AND 10
MG |
MYLAN PHARMACEUTICALS, INC. |
12/14/2005 |
16 |
76-809 |
CLOZAPINE TABLETS USP, 50 MG, 100 MG, AND
200 MG |
GOLDLINE LABORATORIES, INC. |
12/16/2005 |
17 |
77-184 |
TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN
TABLETS, 37.5 MG/325 MG |
CARACO PHARMACEUTICAL LABORATORIES LTD. |
12/16/2005 |
18 |
65-261 |
CEFPROZIL FOR ORAL SUSPENSION USP, 125
MG/5 ML AND 250 MG/5 ML |
LUPIN LIMITED |
12/19/2005 |
19 |
65-267 |
CEFPROZIL TABLETS USP, 250 MG AND 500 MG
|
ORCHID HEALTHCARE |
12/19/2005 |
20 |
77-426 |
RANITIDINE TABLETS USP, 150 MG AND 300 MG
|
COBALT PHARMACEUTICALS, INC. |
12/19/2005 |
21 |
40-664 |
METHYLPREDNISOLONE SODIUM SUCCINATE FOR
INJECTION USP, 40 MG (BASE)/FLIPTOP VIAL |
HOSPIRA INC. |
12/20/2005 |
22 |
40-665 |
METHYLPREDNISOLONE SODIUM SUCCINATE FOR
INJECTION USP, 125 MG (BASE)/FLIPTOP VIAL |
HOSPIRA INC. |
12/20/2005 |
23 |
77-241 |
BACLOFEN TABLETS USP, 20 MG |
LANNETT HOLDINGS, INC. |
12/20/2005 |
24 |
65-281 |
DOXYCYCLINE HYCLATE DELAYED-RELEASE
CAPSULES USP, 75 MG (BASE) AND 100 MG (BASE) |
SANDOZ INC. |
12/21/2005 |
25 |
77-124 |
METFORMIN HYDROCHLORIDE EXTENDED-RELEASE
TABLETS, 500 MG |
MUTUAL PHARMACEUTICAL COMPANY, INC. |
12/21/2005 |
26 |
77-635 |
ZONISAMIDE CAPSULES, 25 MG, 50 MG, AND
100 MG |
MUTUAL PHARMACEUTICAL COMPANY, INC. |
12/22/2005 |
27 |
77-636 |
ZONISAMIDE CAPSULES, 100 MG |
WOCKHARDT LIMITED |
12/22/2005 |
28 |
77-637 |
ZONISAMIDE CAPSULES, 25 MG, 50 MG, AND
100 MG |
MYLAN PHARMACEUTICALS, INC. |
12/22/2005 |
29 |
77-639 |
ZONISAMIDE CAPSULES, 25 MG, 50 MG, AND
100 MG |
BARR LABORATORIES, INC. |
12/22/2005 |
30 |
77-641 |
ZONISAMIDE CAPSULES, 25 MG, 50 MG, AND
100 MG |
TEVA PHARMACEUTICALS USA |
12/22/2005 |
31 |
77-642 |
ZONISAMIDE CAPSULES, 25 MG, 50 MG, AND
100 MG |
APOTEX INC. |
12/22/2005 |
32 |
77-644 |
ZONISAMIDE CAPSULES, 25 MG, 50 MG, AND
100 MG |
SANDOZ INC. |
12/22/2005 |
33 |
77-645 |
ZONISAMIDE CAPSULES, 100 MG |
DR. REDDY'S LABORATORIES LIMITED |
12/22/2005 |
34 |
77-647 |
ZONISAMIDE CAPSULES, 25 MG, 50 MG, AND
100 MG |
ALPHAPHARM PTY LTD |
12/22/2005 |
35 |
77-648 |
ZONISAMIDE CAPSULES, 25 MG, 50 MG, AND
100 MG |
ROXANE LABORATORIES, INC. |
12/22/2005 |
36 |
77-370 |
GLIMEPIRIDE TABLETS, 1 MG, 2 MG, 4 MG,
AND 8 MG |
PAR PHARMACEUTICAL INC. |
12/23/2005 |
37 |
76-310 |
CABERGOLINE TABLETS, 0.5 MG |
PAR PHARMACEUTICAL, INC. |
12/29/2005 |
38 |
76-520 |
FENOFIBRATE TABLETS, 107 MG |
PAR PHARMACEUTICAL, INC. |
12/29/2005 |
39 |
40-608 |
OXYCODONE AND ACETAMINOPHEN TABLETS USP,
2.5 MG/300 MG, 5 MG/300 MG, 7.5 MG/300 MG, AND 10 MG/300
MG |
MIKART INC. |
12/30/2005 |
40 |
65-284 |
CEFPROZIL FOR ORAL SUSPENSION USP, 125
MG/5 ML AND 250 MG/5 ML |
ORCHID HEALTHCARE |
12/30/2005 |