| SIPONIMOD |
218228 |
001 |
ANDA |
SIPONIMOD |
TABLET;ORAL |
0.25MG |
No
|
No
|
2025/01/10
(TA)
|
--
|
CIPLA LTD |
None (Tentative Approval) |
| SIPONIMOD |
218228 |
002 |
ANDA |
SIPONIMOD |
TABLET;ORAL |
1MG |
No
|
No
|
2025/01/10
(TA)
|
--
|
CIPLA LTD |
None (Tentative Approval) |
| SIPONIMOD |
218228 |
003 |
ANDA |
SIPONIMOD |
TABLET;ORAL |
2MG |
No
|
No
|
2025/01/10
(TA)
|
--
|
CIPLA LTD |
None (Tentative Approval) |
| SIPONIMOD |
218444 |
001 |
ANDA |
SIPONIMOD |
TABLET;ORAL |
EQ 0.25MG BASE |
No
|
No
|
2025/04/22
|
2025/04/22
|
RICONPHARMA LLC |
Discontinued |
| SIPONIMOD |
218444 |
002 |
ANDA |
SIPONIMOD |
TABLET;ORAL |
EQ 1MG BASE |
No
|
No
|
2025/04/22
|
2025/04/22
|
RICONPHARMA LLC |
Discontinued |
| SIPONIMOD |
218444 |
003 |
ANDA |
SIPONIMOD |
TABLET;ORAL |
EQ 2MG BASE |
No
|
No
|
2025/04/22
|
2025/04/22
|
RICONPHARMA LLC |
Discontinued |
| SIPONIMOD |
218393 |
001 |
ANDA |
SIPONIMOD |
TABLET |
0.25MG |
No
|
No
|
2025/06/05
(TA)
|
--
|
DR REDDYS LABS LTD |
None (Tentative Approval) |
| SIPONIMOD |
218393 |
002 |
ANDA |
SIPONIMOD |
TABLET |
2MG |
No
|
No
|
2025/06/05
(TA)
|
--
|
DR REDDYS LABS LTD |
None (Tentative Approval) |
| SIPONIMOD |
218393 |
003 |
ANDA |
SIPONIMOD |
TABLET |
1MG |
No
|
No
|
2025/06/05
(TA)
|
--
|
DR REDDYS LABS LTD |
None (Tentative Approval) |