| NINTEDANIB |
212732 |
001 |
ANDA |
NINTEDANIB |
CAPSULE;ORAL |
EQ 100MG BASE |
No
|
No
|
2020/08/04
(TA)
|
--
|
ACCORD HLTHCARE INC |
None (Tentative Approval) |
| NINTEDANIB |
212732 |
002 |
ANDA |
NINTEDANIB |
CAPSULE;ORAL |
EQ 150MG BASE |
No
|
No
|
2020/08/04
(TA)
|
--
|
ACCORD HLTHCARE INC |
None (Tentative Approval) |
| NINTEDANIB |
215123 |
002 |
ANDA |
NINTEDANIB |
CAPSULE;ORAL |
EQ 150MG BASE |
No
|
No
|
2026/02/04
(TA)
|
--
|
EUGIA PHARMA SPECLTS |
None (Tentative Approval) |
| NINTEDANIB |
218472 |
002 |
ANDA |
NINTEDANIB |
CAPSULE |
100MG |
No
|
No
|
2026/03/05
(TA)
|
--
|
HUMANWELL PURACAP PHARMACEUTICALS (WUHAN) CO., LTD |
None (Tentative Approval) |
| NINTEDANIB |
218472 |
003 |
ANDA |
NINTEDANIB |
CAPSULE |
25MG |
No
|
No
|
2026/03/05
(TA)
|
--
|
HUMANWELL PURACAP PHARMACEUTICALS (WUHAN) CO., LTD |
None (Tentative Approval) |
| NINTEDANIB |
219708 |
002 |
ANDA |
NINTEDANIB |
CAPSULE |
100MG |
No
|
No
|
2026/03/17
(TA)
|
--
|
QILU PHARMACEUTICAL CO., LTD. |
None (Tentative Approval) |
| NINTEDANIB |
212555 |
002 |
ANDA |
NINTEDANIB ESYLATE |
CAPSULE;ORAL |
EQ 150MG BASE |
No
|
No
|
2026/03/26
(TA)
|
--
|
GLENMARK PHARMS LTD |
None (Tentative Approval) |
| NINTEDANIB |
219371 |
002 |
ANDA |
NINTEDANIB |
CAPSULE |
100MG |
No
|
No
|
2026/03/26
(TA)
|
--
|
TEVA PHARMACEUTICALS DEVELOPMENT INC |
None (Tentative Approval) |
| NINTEDANIB |
219371 |
003 |
ANDA |
NINTEDANIB |
CAPSULE |
25MG |
No
|
No
|
2026/03/26
(TA)
|
--
|
TEVA PHARMACEUTICALS DEVELOPMENT INC |
None (Tentative Approval) |
| NINTEDANIB ESYLATE |
212609 |
001 |
ANDA |
NINTEDANIB ESYLATE |
CAPSULE;ORAL |
EQ 100MG BASE |
No
|
No
|
2026/04/02
|
2026/04/02
|
CIPLA |
Prescription |
| NINTEDANIB ESYLATE |
212609 |
002 |
ANDA |
NINTEDANIB ESYLATE |
CAPSULE;ORAL |
EQ 150MG BASE |
No
|
No
|
2026/04/02
|
2026/04/02
|
CIPLA |
Prescription |
| NINTEDANIB ESYLATE |
216915 |
001 |
ANDA |
NINTEDANIB ESYLATE |
CAPSULE;ORAL |
EQ 100MG BASE |
No
|
No
|
2026/04/02
|
2026/04/02
|
SANDOZ |
Prescription |
| NINTEDANIB ESYLATE |
216915 |
002 |
ANDA |
NINTEDANIB ESYLATE |
CAPSULE;ORAL |
EQ 150MG BASE |
No
|
No
|
2026/04/02
|
2026/04/02
|
SANDOZ |
Prescription |
| NINTEDANIB ESYLATE |
219227 |
001 |
ANDA |
NINTEDANIB ESYLATE |
CAPSULE;ORAL |
EQ 100MG BASE |
No
|
No
|
2026/04/02
|
2026/04/02
|
APOTEX |
Prescription |
| NINTEDANIB ESYLATE |
219227 |
002 |
ANDA |
NINTEDANIB ESYLATE |
CAPSULE;ORAL |
EQ 150MG BASE |
No
|
No
|
2026/04/02
|
2026/04/02
|
APOTEX |
Prescription |
| NINTEDANIB ESYLATE |
219283 |
001 |
ANDA |
NINTEDANIB ESYLATE |
CAPSULE;ORAL |
EQ 100MG BASE |
No
|
No
|
2026/04/02
|
2026/04/02
|
DR REDDYS |
Prescription |
| NINTEDANIB ESYLATE |
219283 |
002 |
ANDA |
NINTEDANIB ESYLATE |
CAPSULE;ORAL |
EQ 150MG BASE |
No
|
No
|
2026/04/02
|
2026/04/02
|
DR REDDYS |
Prescription |
| NINTEDANIB ESYLATE |
219819 |
001 |
ANDA |
NINTEDANIB ESYLATE |
CAPSULE;ORAL |
EQ 100MG BASE |
No
|
No
|
2026/04/02
|
2026/04/02
|
DEXCEL |
Prescription |
| NINTEDANIB ESYLATE |
219819 |
002 |
ANDA |
NINTEDANIB ESYLATE |
CAPSULE;ORAL |
EQ 150MG BASE |
No
|
No
|
2026/04/02
|
2026/04/02
|
DEXCEL |
Prescription |