| BRIVARACETAM |
214848 |
002 |
ANDA |
BRIVARACETAM |
TABLET;ORAL |
100MG |
No
|
No
|
2023/01/06
|
2023/01/06
|
AUROBINDO PHARMA LTD |
Discontinued |
| BRIVARACETAM |
214875 |
001 |
ANDA |
BRIVARACETAM |
TABLET;ORAL |
10MG |
No
|
No
|
2023/11/06
(TA)
|
--
|
APOTEX INC |
None (Tentative Approval) |
| BRIVARACETAM |
214875 |
002 |
ANDA |
BRIVARACETAM |
TABLET;ORAL |
25MG |
No
|
No
|
2023/11/06
(TA)
|
--
|
APOTEX INC |
None (Tentative Approval) |
| BRIVARACETAM |
214875 |
003 |
ANDA |
BRIVARACETAM |
TABLET;ORAL |
50MG |
No
|
No
|
2023/11/06
(TA)
|
--
|
APOTEX INC |
None (Tentative Approval) |
| BRIVARACETAM |
214875 |
004 |
ANDA |
BRIVARACETAM |
TABLET;ORAL |
75MG |
No
|
No
|
2023/11/06
(TA)
|
--
|
APOTEX INC |
None (Tentative Approval) |
| BRIVARACETAM |
214875 |
005 |
ANDA |
BRIVARACETAM |
TABLET;ORAL |
100MG |
No
|
No
|
2023/11/06
(TA)
|
--
|
APOTEX INC |
None (Tentative Approval) |
| BRIVARACETAM |
214921 |
002 |
ANDA |
BRIVARACETAM |
TABLET;ORAL |
25MG |
No
|
No
|
2023/11/09
(TA)
|
--
|
MSN LABORATORIES PRIVATE LTD |
None (Tentative Approval) |
| BRIVARACETAM |
214921 |
003 |
ANDA |
BRIVARACETAM |
TABLET;ORAL |
50MG |
No
|
No
|
2023/11/09
(TA)
|
--
|
MSN LABORATORIES PRIVATE LTD |
None (Tentative Approval) |
| BRIVARACETAM |
214921 |
004 |
ANDA |
BRIVARACETAM |
TABLET;ORAL |
75MG |
No
|
No
|
2023/11/09
(TA)
|
--
|
MSN LABORATORIES PRIVATE LTD |
None (Tentative Approval) |
| BRIVARACETAM |
214921 |
005 |
ANDA |
BRIVARACETAM |
TABLET;ORAL |
100MG |
No
|
No
|
2023/11/09
(TA)
|
--
|
MSN LABORATORIES PRIVATE LTD |
None (Tentative Approval) |
| BRIVARACETAM |
214922 |
001 |
ANDA |
BRIVARACETAM |
SOLUTION; ORAL |
10MG/ML |
No
|
No
|
2023/11/09
(TA)
|
--
|
MSN LABS PVT LTD |
None (Tentative Approval) |
| BRIVARACETAM |
214924 |
001 |
ANDA |
BRIVARACETAM |
SOLUTION;INTRAVENOUS |
50MG/5ML (10MG/ML) |
No
|
No
|
2023/11/09
(TA)
|
--
|
MSN LABORATORIES PRIVATE LTD |
None (Tentative Approval) |