SAFINAMIDE |
216020 |
001 |
ANDA |
SAFINAMIDE |
TABLET;ORAL |
50MG |
No
|
No
|
2023/01/12
(TA)
|
--
|
OPTIMUS PHARMA PRIVATE LTD |
None (Tentative Approval) |
SAFINAMIDE |
216020 |
002 |
ANDA |
SAFINAMIDE |
TABLET;ORAL |
100MG |
No
|
No
|
2023/01/12
(TA)
|
--
|
OPTIMUS PHARMA PRIVATE LTD |
None (Tentative Approval) |
SAFINAMIDE |
215945 |
001 |
ANDA |
SAFINAMIDE |
TABLET;ORAL |
50MG |
No
|
No
|
2023/05/03
(TA)
|
--
|
RK PHARMA |
None (Tentative Approval) |
SAFINAMIDE |
215945 |
002 |
ANDA |
SAFINAMIDE |
TABLET;ORAL |
100MG |
No
|
No
|
2023/05/03
(TA)
|
--
|
RK PHARMA |
None (Tentative Approval) |
SAFINAMIDE MESYLATE |
215902 |
001 |
ANDA |
SAFINAMIDE MESYLATE |
TABLET;ORAL |
EQ 50MG BASE |
No
|
No
|
2023/06/14
|
2023/06/14
|
AUROBINDO PHARMA |
Discontinued |
SAFINAMIDE MESYLATE |
215902 |
002 |
ANDA |
SAFINAMIDE MESYLATE |
TABLET;ORAL |
EQ 100MG BASE |
No
|
No
|
2023/06/14
|
2023/06/14
|
AUROBINDO PHARMA |
Discontinued |
SAFINAMIDE MESYLATE |
215739 |
001 |
ANDA |
SAFINAMIDE MESYLATE |
TABLET;ORAL |
EQ 50MG BASE |
No
|
No
|
2024/04/25
|
2024/04/25
|
PRINSTON INC |
Prescription |
SAFINAMIDE MESYLATE |
215739 |
002 |
ANDA |
SAFINAMIDE MESYLATE |
TABLET;ORAL |
EQ 100MG BASE |
No
|
No
|
2024/04/25
|
2024/04/25
|
PRINSTON INC |
Prescription |