| MIRABEGRON |
209413 |
001 |
ANDA |
MIRABEGRON |
TABLET, EXTENDED RELEASE;ORAL |
50MG |
No
|
No
|
2018/10/12
(TA)
|
--
|
AUROBINDO PHARMA LTD |
None (Tentative Approval) |
| MIRABEGRON |
209446 |
001 |
ANDA |
MIRABEGRON |
TABLET, EXTENDED RELEASE;ORAL |
25MG |
No
|
No
|
2019/12/27
|
2019/12/27
|
SAWAI USA |
Discontinued |
| MIRABEGRON |
209485 |
001 |
ANDA |
MIRABEGRON |
TABLET, EXTENDED RELEASE;ORAL |
25MG |
No
|
No
|
2022/09/28
|
2022/09/28
|
LUPIN LTD |
Prescription |
| MIRABEGRON |
209485 |
002 |
ANDA |
MIRABEGRON |
TABLET, EXTENDED RELEASE;ORAL |
50MG |
No
|
No
|
2022/09/28
|
2022/09/28
|
LUPIN LTD |
Prescription |
| MIRABEGRON |
209488 |
001 |
ANDA |
MIRABEGRON |
TABLET, EXTENDED RELEASE;ORAL |
25MG |
No
|
No
|
2022/09/29
|
2022/09/29
|
ZYDUS PHARMS |
Prescription |
| MIRABEGRON |
209488 |
002 |
ANDA |
MIRABEGRON |
TABLET, EXTENDED RELEASE;ORAL |
50MG |
No
|
No
|
2022/09/29
|
2022/09/29
|
ZYDUS PHARMS |
Prescription |
| MIRABEGRON |
215948 |
001 |
ANDA |
MIRABEGRON |
TABLET, EXTENDED RELEASE;ORAL |
25MG |
No
|
No
|
2024/02/12
|
2024/02/12
|
ALKEM LABS LTD |
Prescription |
| MIRABEGRON |
215948 |
002 |
ANDA |
MIRABEGRON |
TABLET, EXTENDED RELEASE;ORAL |
50MG |
No
|
No
|
2024/02/12
|
2024/02/12
|
ALKEM LABS LTD |
Prescription |
| MIRABEGRON |
209434 |
001 |
ANDA |
MIRABEGRON |
TABLET, EXTENDED RELEASE;ORAL |
25MG |
No
|
No
|
2025/01/02
|
2025/01/02
|
APOTEX |
Discontinued |
| MIRABEGRON |
209434 |
002 |
ANDA |
MIRABEGRON |
TABLET, EXTENDED RELEASE;ORAL |
50MG |
No
|
No
|
2025/01/02
|
2025/01/02
|
APOTEX |
Discontinued |
| MIRABEGRON |
217061 |
001 |
ANDA |
MIRABEGRON |
TABLET, EXTENDED RELEASE;ORAL |
50MG |
No
|
No
|
2025/05/06
|
2025/05/06
|
SAWAI USA |
Discontinued |
| MIRABEGRON |
217989 |
001 |
ANDA |
MIRABEGRON |
TABLET, EXTENDED RELEASE;ORAL |
25MG |
No
|
No
|
2025/06/30
|
2025/06/30
|
QILU |
Prescription |
| MIRABEGRON |
217989 |
002 |
ANDA |
MIRABEGRON |
TABLET, EXTENDED RELEASE;ORAL |
50MG |
No
|
No
|
2025/06/30
|
2025/06/30
|
QILU |
Prescription |
| MIRABEGRON |
218172 |
001 |
ANDA |
MIRABEGRON |
TABLET, EXTENDED RELEASE;ORAL |
25MG |
No
|
No
|
2025/09/24
|
2025/09/24
|
ASCENT PHARMS INC |
Prescription |
| MIRABEGRON |
218172 |
002 |
ANDA |
MIRABEGRON |
TABLET, EXTENDED RELEASE;ORAL |
50MG |
No
|
No
|
2025/09/24
|
2025/09/24
|
ASCENT PHARMS INC |
Prescription |
| MIRABEGRON |
218543 |
001 |
ANDA |
MIRABEGRON |
TABLET, EXTENDED RELEASE;ORAL |
25MG |
No
|
No
|
2025/11/04
|
2025/11/04
|
MSN |
Prescription |
| MIRABEGRON |
218543 |
002 |
ANDA |
MIRABEGRON |
TABLET, EXTENDED RELEASE;ORAL |
50MG |
No
|
No
|
2025/11/04
|
2025/11/04
|
MSN |
Prescription |