| PITOLISANT |
218873 |
002 |
ANDA |
PITOLISANT |
TABLET; FILM COATED |
4.45MG |
No
|
No
|
2025/05/06
(TA)
|
--
|
MSN LABORATORIES PRIVATE LTD |
None (Tentative Approval) |
| PITOLISANT |
218832 |
002 |
ANDA |
PITOLISANT |
TABLET |
17.8MG |
No
|
No
|
2025/09/02
(TA)
|
--
|
ANNORA PHARMA PRIVATE LIMITED |
None (Tentative Approval) |
| PITOLISANT |
218846 |
002 |
ANDA |
PITOLISANT |
TABLET |
17.8MG |
No
|
No
|
2026/03/23
(TA)
|
--
|
LUPIN LIMITED |
None (Tentative Approval) |
| PITOLISANT |
218495 |
002 |
ANDA |
PITOLISANT |
TABLET |
17.8MG |
No
|
No
|
2026/03/24
(TA)
|
--
|
NOVITIUM PHARMA LLC |
None (Tentative Approval) |