| APIXABAN |
210108 |
005 |
ANDA |
APIXABAN |
TABLET; FILM COATED |
2.5MG |
No
|
No
|
2025/11/04
(TA)
|
--
|
UNICHEM LABS LTD |
None (Tentative Approval) |
| APIXABAN |
218519 |
002 |
ANDA |
APIXABAN |
TABLET |
1.5MG |
No
|
No
|
2025/12/19
(TA)
|
--
|
FOSUN WANBANG (JIANGSU) PHARMACEUTICAL GROUP CO., |
None (Tentative Approval) |
| APIXABAN |
218519 |
003 |
ANDA |
APIXABAN |
TABLET |
2.0MG |
No
|
No
|
2025/12/19
(TA)
|
--
|
FOSUN WANBANG (JIANGSU) PHARMACEUTICAL GROUP CO., |
None (Tentative Approval) |
| APIXABAN |
218519 |
004 |
ANDA |
APIXABAN |
TABLET |
5MG |
No
|
No
|
2025/12/19
(TA)
|
--
|
FOSUN WANBANG (JIANGSU) PHARMACEUTICAL GROUP CO., |
None (Tentative Approval) |
| APIXABAN |
218519 |
005 |
ANDA |
APIXABAN |
TABLET |
2.5MG |
No
|
No
|
2025/12/19
(TA)
|
--
|
FOSUN WANBANG (JIANGSU) PHARMACEUTICAL GROUP CO., |
None (Tentative Approval) |