|
ANDA Number |
Generic Drug Name |
Applicant |
Tentative Approval Date |
1 |
77-672 |
STAVUDINE CAPSULES USP, 30 MG AND 40 MG |
AUROBINDO PHARMA LIMITED |
7/1/2005 |
2 |
77-558 |
LAMIVUDINE AND ZIDOVUDINE TABLETS 150 MG/300
MG |
AUROBINDO PHARMA LTD. |
7/6/2005 |
3 |
76-715 |
MODAFINIL TABLETS 100 MG AND 200 MG |
CARLSBAD TERCHNOLOGY, INC. |
7/13/2005 |
4 |
77-327 |
ZIDOVUDINE TABLETS USP, 300 MG |
RANBAXY LABORATORIES LIMITED |
7/13/2005 |
5 |
76-914 |
TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN
TABLETS 37.5 MG/325 MG |
TEVA PHARMACEUTICALS USA |
7/18/2005 |
6 |
76-447 |
FEXOFENADINE HYDROCHLORIDE TABLETS 30 MG, 60
MG, AND 180 MG |
TEVA PHARMACEUTICALS, USA |
7/19/2005 |
7 |
76-875 |
GLIMEPIRIDE TABLETS 1 MG, 2 MG, 4 MG, AND 8
MG |
RANBAXY LABORATORIES LIMITED |
7/20/2005 |
8 |
76-944 |
SERTRALINE HYDROCHLORIDE TABLETS 25 MG
(BASE), 50 MG (BASE), AND 100 MG (BASE) |
ANDRX PHARMACEUTICALS, LLC |
7/21/2005 |
9 |
76-844 |
ZIDOVUDINE TABLETS USP, 300 MG |
ROXANE LABORATORIES, INC. |
7/27/2005 |
10 |
77-366 |
GLIMEPIRIDE TABLETS 3 MG AND 6 MG |
RANBAXY LABORATORIES LIMITED |
7/27/2005 |
11 |
77-009 |
ONDANSETRON ORAL SOLUTION USP, 4 MG/5 ML |
TARO PHARMACEUTICAL INDUSTRIES, LTD. |
7/28/2005 |
12 |
76-572 |
SUMATRIPTAN SUCCINATE TABLETS 100 MG (BASE) |
RANBAXY LABORATORIES LIMITED |
7/29/2005 |
13 |
76-554 |
SUMATRIPTAN SUCCINATE TABLETS 25 MG (BASE)
AND 50 MG (BASE) |
RANBAXY LABORATORIES LIMITED |
7/29/2005 |
14 |
76-933 |
SUMATRIPTAN SUCCINATE TABLETS 25 MG (BASE),
50 MG (BASE), AND 100 MG (BASE) |
COBALT PHARMACEUTICALS, INC. |
7/29/2005 |