| RIVAROXABAN |
212220 |
001 |
ANDA |
RIVAROXABAN |
TABLET;ORAL |
2.5MG |
No
|
No
|
2022/06/27
(TA)
|
--
|
MYLAN PHARMS INC |
None (Tentative Approval) |
| RIVAROXABAN |
210301 |
001 |
ANDA |
RIVAROXABAN |
TABLET;ORAL |
2.5MG |
No
|
No
|
2023/10/17
(TA)
|
--
|
ALEMBIC PHARMS LTD |
None (Tentative Approval) |
| RIVAROXABAN |
217810 |
001 |
ANDA |
RIVAROXABAN |
TABLET;ORAL |
2.5MG |
No
|
No
|
2024/10/15
(TA)
|
2025/05/02
|
APOTEX |
Prescription |
| RIVAROXABAN |
208534 |
002 |
ANDA |
RIVAROXABAN |
TABLET;ORAL |
10MG |
No
|
No
|
2024/11/12
(TA)
|
--
|
DR REDDYS LABS LTD |
None (Tentative Approval) |
| RIVAROXABAN |
208534 |
003 |
ANDA |
RIVAROXABAN |
TABLET;ORAL |
15MG |
No
|
No
|
2024/11/12
(TA)
|
--
|
DR REDDYS LABS LTD |
None (Tentative Approval) |
| RIVAROXABAN |
208534 |
004 |
ANDA |
RIVAROXABAN |
TABLET;ORAL |
20MG |
No
|
No
|
2024/11/12
(TA)
|
--
|
DR REDDYS LABS LTD |
None (Tentative Approval) |
| RIVAROXABAN |
208549 |
001 |
ANDA |
RIVAROXABAN |
TABLET;ORAL |
10MG |
No
|
No
|
2024/12/06
(TA)
|
--
|
PRINSTON INC |
None (Tentative Approval) |
| RIVAROXABAN |
208549 |
002 |
ANDA |
RIVAROXABAN |
TABLET;ORAL |
15MG |
No
|
No
|
2024/12/06
(TA)
|
--
|
PRINSTON INC |
None (Tentative Approval) |
| RIVAROXABAN |
208549 |
003 |
ANDA |
RIVAROXABAN |
TABLET;ORAL |
20MG |
No
|
No
|
2024/12/06
(TA)
|
--
|
PRINSTON INC |
None (Tentative Approval) |
| RIVAROXABAN |
208555 |
001 |
ANDA |
RIVAROXABAN |
TABLET;ORAL |
2.5MG |
No
|
No
|
2025/03/03
|
2025/03/03
|
LUPIN LTD |
Prescription |
| RIVAROXABAN |
208555 |
001 |
ANDA |
RIVAROXABAN |
TABLET;ORAL |
2.5MG |
No
|
No
|
2025/03/03
(TA)
|
2025/03/03
|
LUPIN LTD |
Prescription |
| RIVAROXABAN |
208555 |
002 |
ANDA |
RIVAROXABAN |
TABLET |
10MG |
No
|
No
|
2025/03/03
|
--
|
LUPIN LTD |
None (Tentative Approval) |
| RIVAROXABAN |
208555 |
002 |
ANDA |
RIVAROXABAN |
TABLET |
10MG |
No
|
No
|
2025/03/03
(TA)
|
--
|
LUPIN LTD |
None (Tentative Approval) |
| RIVAROXABAN |
208555 |
003 |
ANDA |
RIVAROXABAN |
TABLET |
15MG |
No
|
No
|
2025/03/03
|
--
|
LUPIN LTD |
None (Tentative Approval) |
| RIVAROXABAN |
208555 |
003 |
ANDA |
RIVAROXABAN |
TABLET |
15MG |
No
|
No
|
2025/03/03
(TA)
|
--
|
LUPIN LTD |
None (Tentative Approval) |
| RIVAROXABAN |
208555 |
004 |
ANDA |
RIVAROXABAN |
TABLET |
20MG |
No
|
No
|
2025/03/03
|
--
|
LUPIN LTD |
None (Tentative Approval) |
| RIVAROXABAN |
208555 |
004 |
ANDA |
RIVAROXABAN |
TABLET |
20MG |
No
|
No
|
2025/03/03
(TA)
|
--
|
LUPIN LTD |
None (Tentative Approval) |
| RIVAROXABAN |
208557 |
001 |
ANDA |
RIVAROXABAN |
TABLET;ORAL |
2.5MG |
No
|
No
|
2025/03/03
|
2025/03/03
|
TARO |
Prescription |
| RIVAROXABAN |
208557 |
001 |
ANDA |
RIVAROXABAN |
TABLET;ORAL |
2.5MG |
No
|
No
|
2025/03/03
(TA)
|
2025/03/03
|
TARO |
Prescription |
| RIVAROXABAN |
208557 |
002 |
ANDA |
RIVAROXABAN |
TABLET;ORAL |
10MG |
No
|
No
|
2025/03/03
|
--
|
TARO |
None (Tentative Approval) |