| AMPHETAMINE |
209253 |
006 |
ANDA |
AMPHETAMINE |
TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE;ORAL |
EQ 18.8MG BASE |
No
|
No
|
2023/06/22
|
2023/06/22
|
ACTAVIS LABS FL INC |
Prescription |
| AMPHETAMINE |
219800 |
001 |
ANDA |
AMPHETAMINE |
TABLET, ORALLY DISINTEGRATING;ORAL |
3.1MG |
No
|
No
|
2025/12/19
(TA)
|
--
|
GRANULES PHARMACEUTICALS INC |
None (Tentative Approval) |
| AMPHETAMINE |
219800 |
002 |
ANDA |
AMPHETAMINE |
TABLET, ORALLY DISINTEGRATING;ORAL |
6.3MG |
No
|
No
|
2025/12/19
(TA)
|
--
|
GRANULES PHARMACEUTICALS INC |
None (Tentative Approval) |
| AMPHETAMINE |
219800 |
003 |
ANDA |
AMPHETAMINE |
TABLET, ORALLY DISINTEGRATING;ORAL |
9.4MG |
No
|
No
|
2025/12/19
(TA)
|
--
|
GRANULES PHARMACEUTICALS INC |
None (Tentative Approval) |
| AMPHETAMINE |
219800 |
004 |
ANDA |
AMPHETAMINE |
TABLET, ORALLY DISINTEGRATING;ORAL |
12.5MG |
No
|
No
|
2025/12/19
(TA)
|
--
|
GRANULES PHARMACEUTICALS INC |
None (Tentative Approval) |
| AMPHETAMINE |
219800 |
005 |
ANDA |
AMPHETAMINE |
TABLET, ORALLY DISINTEGRATING;ORAL |
15.7MG |
No
|
No
|
2025/12/19
(TA)
|
--
|
GRANULES PHARMACEUTICALS INC |
None (Tentative Approval) |
| AMPHETAMINE |
219800 |
006 |
ANDA |
AMPHETAMINE |
TABLET, ORALLY DISINTEGRATING;ORAL |
18.8MG |
No
|
No
|
2025/12/19
(TA)
|
--
|
GRANULES PHARMACEUTICALS INC |
None (Tentative Approval) |
| AMPHETAMINE |
220284 |
002 |
ANDA |
AMPHETAMINE |
TABLET, EXTENDED RELEASE |
10MG |
No
|
No
|
2026/01/07
(TA)
|
--
|
GRANULES PHARMACEUTICALS INC |
None (Tentative Approval) |
| AMPHETAMINE |
220284 |
003 |
ANDA |
AMPHETAMINE |
TABLET, EXTENDED RELEASE |
15MG |
No
|
No
|
2026/01/07
(TA)
|
--
|
GRANULES PHARMACEUTICALS INC |
None (Tentative Approval) |
| AMPHETAMINE |
220284 |
004 |
ANDA |
AMPHETAMINE |
TABLET, EXTENDED RELEASE |
20MG |
No
|
No
|
2026/01/07
(TA)
|
--
|
GRANULES PHARMACEUTICALS INC |
None (Tentative Approval) |