| DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE |
219755 |
004 |
ANDA |
DAPAGLIFLOZIN, METFORMIN HYDROCHLORIDE |
TABLET, EXTENDED RELEASE |
500MG |
No
|
No
|
2026/04/09
(TA)
|
--
|
INVENTIA HEALTHCARE LIMITED |
None (Tentative Approval) |
| DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE |
219755 |
005 |
ANDA |
DAPAGLIFLOZIN, METFORMIN HYDROCHLORIDE |
TABLET, EXTENDED RELEASE |
2.5MG |
No
|
No
|
2026/04/09
(TA)
|
--
|
INVENTIA HEALTHCARE LIMITED |
None (Tentative Approval) |
| DAPAGLIFLOZIN |
219408 |
001 |
ANDA |
DAPAGLIFLOZIN |
TABLET |
5MG |
No
|
No
|
2026/04/30
(TA)
|
--
|
SCIEGEN PHARMACEUTICALS INC |
None (Tentative Approval) |
| DAPAGLIFLOZIN |
219408 |
002 |
ANDA |
DAPAGLIFLOZIN |
TABLET |
10MG |
No
|
No
|
2026/04/30
(TA)
|
--
|
SCIEGEN PHARMACEUTICALS INC |
None (Tentative Approval) |
| DAPAGLIFLOZIN |
220679 |
002 |
ANDA |
DAPAGLIFLOZIN |
TABLET |
10MG |
No
|
No
|
2026/05/06
(TA)
|
--
|
CENTAUR PHARMACEUTICALS PRIVATE LIMITED |
None (Tentative Approval) |