| SELEXIPAG |
214414 |
005 |
ANDA |
SELEXIPAG |
TABLET;ORAL |
1.4MG |
No
|
No
|
2023/10/11
|
2023/10/11
|
ALEMBIC |
Prescription |
| SELEXIPAG |
214414 |
006 |
ANDA |
SELEXIPAG |
TABLET;ORAL |
1.6MG |
No
|
No
|
2023/10/11
|
2023/10/11
|
ALEMBIC |
Prescription |
| SELEXIPAG |
219117 |
002 |
ANDA |
SELEXIPAG |
TABLET |
1200UG |
No
|
No
|
2025/12/23
(TA)
|
--
|
LANNETT CO INC |
None (Tentative Approval) |
| SELEXIPAG |
219117 |
003 |
ANDA |
SELEXIPAG |
TABLET |
400UG |
No
|
No
|
2025/12/23
(TA)
|
--
|
LANNETT CO INC |
None (Tentative Approval) |
| SELEXIPAG |
219117 |
004 |
ANDA |
SELEXIPAG |
TABLET |
1000UG |
No
|
No
|
2025/12/23
(TA)
|
--
|
LANNETT CO INC |
None (Tentative Approval) |
| SELEXIPAG |
219117 |
005 |
ANDA |
SELEXIPAG |
TABLET |
1600UG |
No
|
No
|
2025/12/23
(TA)
|
--
|
LANNETT CO INC |
None (Tentative Approval) |
| SELEXIPAG |
219117 |
006 |
ANDA |
SELEXIPAG |
TABLET |
800UG |
No
|
No
|
2025/12/23
(TA)
|
--
|
LANNETT CO INC |
None (Tentative Approval) |
| SELEXIPAG |
219117 |
007 |
ANDA |
SELEXIPAG |
TABLET |
600UG |
No
|
No
|
2025/12/23
(TA)
|
--
|
LANNETT CO INC |
None (Tentative Approval) |
| SELEXIPAG |
219117 |
008 |
ANDA |
SELEXIPAG |
TABLET |
200UG |
No
|
No
|
2025/12/23
(TA)
|
--
|
LANNETT CO INC |
None (Tentative Approval) |
| SELEXIPAG |
214367 |
001 |
ANDA |
SELEXIPAG |
TABLET;ORAL |
0.2MG |
No
|
No
|
2026/01/16
(TA)
|
--
|
MSN LABORATORIES PRIVATE LTD |
None (Tentative Approval) |
| SELEXIPAG |
214367 |
002 |
ANDA |
SELEXIPAG |
TABLET;ORAL |
0.4MG |
No
|
No
|
2026/01/16
(TA)
|
--
|
MSN LABORATORIES PRIVATE LTD |
None (Tentative Approval) |
| SELEXIPAG |
214367 |
003 |
ANDA |
SELEXIPAG |
TABLET;ORAL |
0.6MG |
No
|
No
|
2026/01/16
(TA)
|
--
|
MSN LABORATORIES PRIVATE LTD |
None (Tentative Approval) |
| SELEXIPAG |
214367 |
004 |
ANDA |
SELEXIPAG |
TABLET;ORAL |
0.8MG |
No
|
No
|
2026/01/16
(TA)
|
--
|
MSN LABORATORIES PRIVATE LTD |
None (Tentative Approval) |
| SELEXIPAG |
214367 |
005 |
ANDA |
SELEXIPAG |
TABLET;ORAL |
1MG |
No
|
No
|
2026/01/16
(TA)
|
--
|
MSN LABORATORIES PRIVATE LTD |
None (Tentative Approval) |
| SELEXIPAG |
214367 |
006 |
ANDA |
SELEXIPAG |
TABLET;ORAL |
1.2MG |
No
|
No
|
2026/01/16
(TA)
|
--
|
MSN LABORATORIES PRIVATE LTD |
None (Tentative Approval) |
| SELEXIPAG |
214367 |
007 |
ANDA |
SELEXIPAG |
TABLET;ORAL |
1.4MG |
No
|
No
|
2026/01/16
(TA)
|
--
|
MSN LABORATORIES PRIVATE LTD |
None (Tentative Approval) |
| SELEXIPAG |
214367 |
008 |
ANDA |
SELEXIPAG |
TABLET;ORAL |
1.6MG |
No
|
No
|
2026/01/16
(TA)
|
--
|
MSN LABORATORIES PRIVATE LTD |
None (Tentative Approval) |