|
Office of
Generic Drugs - First Time Generics - October 2000
|
ANDA No |
Established
Name/Dosage Form and Strength |
Applicant |
Submission
Date |
|
Approval
Date |
|
75-466 |
DOXASOZIN MESYLATE TABLETS 1
MG (BASE), |
GENPHARM, INC. |
9/28/98 |
10/18/00 |
|
2 MG (BASE), 4 MG (BASE), 8 MG
(BASE) |
|
75-580 |
DOXAZOSIN MESYLATE TABLETS 1
MG (BASE), |
TORPHARM |
2/12/99 |
10/18/00 |
|
2 MG (BASE), 4 MG (BASE), 8 MG
(BASE) |
|
75-426 |
DOXAZOSIN MESYLATE TABLETS 1
MG (BASE), |
CHELSEA LABORATORIES, INC. |
8/3/98 |
10/18/00 |
|
2 MG (BASE), 4 MG (BASE), 8 MG
(BASE) |
|
75-646 |
DOXAZOSIN MESYLATE TABLETS 1
MG (BASE), |
EON LABS MANUFACTURING, INC. |
6/10/99 |
10/18/00 |
|
2 MG (BASE), 4 MG (BASE), 8 MG
(BASE) |
|
75-574 |
DOXAZOSIN MESYLATE TABLETS 1
MG (BASE), |
PUREPAC PHARMACEUTICAL CO. |
2/2/99 |
10/18/00 |
|
2 MG (BASE), 4 MG (BASE), 8 MG
(BASE) |
|
75-536 |
DOXAZOSIN MESYLATE TABLETS 1
MG (BASE), |
TEVA PHARMACEUTICALS USA |
12/28/98 |
10/18/00 |
|
2 MG (BASE), 4 MG (BASE), 8 MG
(BASE) |
|
75-453 |
DOXASOZIN MESYLATE TABLETS 1
MG (BASE), |
ZENITH GOLDLINE |
12/30/98 |
10/18/00 |
|
2 MG (BASE), 4 MG (BASE), 8 MG
(BASE) |
|
75-203 |
PROPAFENONE HYDROCHLORIDE
TABLETS, 150 MG, |
WATSON LABORATORIES, INC. |
9/15/97 |
10/24/00 |
Back to Top Back to Approvals
FDA/Center for Drug Evaluation and Research
Last Updated: September 10, 200125 Apr 2006 08:54:31 -0400
Originator: OGD
HTML by PKS |