DAPAGLIFLOZIN;METFORMIN HYDROCHLORIDE |
211583 |
004 |
ANDA |
DAPAGLIFLOZIN;METFORMIN HYDROCHLORIDE |
TABLET, EXTENDED RELEASE;ORAL |
10MG/500MG |
No
|
No
|
2022/08/03
(TA)
|
--
|
TEVA PHARMS USA INC |
None (Tentative Approval) |
DAPAGLIFLOZIN;METFORMIN HYDROCHLORIDE |
211583 |
005 |
ANDA |
DAPAGLIFLOZIN;METFORMIN HYDROCHLORIDE |
TABLET, EXTENDED RELEASE;ORAL |
10MG/1000MG |
No
|
No
|
2022/08/03
(TA)
|
--
|
TEVA PHARMS USA INC |
None (Tentative Approval) |
DAPAGLIFLOZIN |
211523 |
001 |
ANDA |
DAPAGLIFLOZIN |
TABLET; ORAL |
5MG |
No
|
No
|
2023/03/03
(TA)
|
--
|
AIZANT |
None (Tentative Approval) |
DAPAGLIFLOZIN |
211523 |
002 |
ANDA |
DAPAGLIFLOZIN |
TABLET; ORAL |
10MG |
No
|
No
|
2023/03/03
(TA)
|
--
|
AIZANT |
None (Tentative Approval) |
DAPAGLIFLOZIN AND SAXAGLIPTIN MONOHYDRATE |
211532 |
001 |
ANDA |
DAPAGLIFLOZIN, SAXAGLIPTIN MONOHYDRATE |
TABLET; ORAL |
5MG |
No
|
No
|
2024/01/03
(TA)
|
--
|
LUPIN LTD |
None (Tentative Approval) |
DAPAGLIFLOZIN AND SAXAGLIPTIN MONOHYDRATE |
211532 |
002 |
ANDA |
DAPAGLIFLOZIN, SAXAGLIPTIN MONOHYDRATE |
TABLET; ORAL |
10MG |
No
|
No
|
2024/01/03
(TA)
|
--
|
LUPIN LTD |
None (Tentative Approval) |
DAPAGLIFLOZIN |
211582 |
001 |
ANDA |
DAPAGLIFLOZIN |
TABLET;ORAL |
5MG |
No
|
No
|
2024/02/28
(TA)
|
--
|
ZYDUS PHARMS |
None (Tentative Approval) |
DAPAGLIFLOZIN |
211582 |
002 |
ANDA |
DAPAGLIFLOZIN |
TABLET;ORAL |
10MG |
No
|
No
|
2024/02/28
(TA)
|
--
|
ZYDUS PHARMS |
None (Tentative Approval) |