| DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE |
211559 |
002 |
ANDA |
DAPAGLIFLOZIN, METFORMIN HYDROCHLORIDE |
TABLET, EXTENDED RELEASE |
10MG |
No
|
No
|
2025/08/19
(TA)
|
--
|
MACLEODS PHARMACEUTICALS LTD |
None (Tentative Approval) |
| DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE |
211559 |
003 |
ANDA |
DAPAGLIFLOZIN, METFORMIN HYDROCHLORIDE |
TABLET, EXTENDED RELEASE |
5MG |
No
|
No
|
2025/08/19
(TA)
|
--
|
MACLEODS PHARMACEUTICALS LTD |
None (Tentative Approval) |
| DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE |
211559 |
004 |
ANDA |
DAPAGLIFLOZIN, METFORMIN HYDROCHLORIDE |
TABLET, EXTENDED RELEASE |
500MG |
No
|
No
|
2025/08/19
(TA)
|
--
|
MACLEODS PHARMACEUTICALS LTD |
None (Tentative Approval) |
| DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE |
211559 |
005 |
ANDA |
DAPAGLIFLOZIN, METFORMIN HYDROCHLORIDE |
TABLET, EXTENDED RELEASE |
2.5MG |
No
|
No
|
2025/08/19
(TA)
|
--
|
MACLEODS PHARMACEUTICALS LTD |
None (Tentative Approval) |