| SITAGLIPTIN AND METFORMIN HYDROCHLORIDE |
215220 |
002 |
ANDA |
SITAGLIPTIN; METFORMIN HYDROCHLORIDE |
TABLET; ORAL |
50MG/1000MG |
No
|
No
|
2025/12/31
(TA)
|
--
|
AJANTA PHARMA LTD |
None (Tentative Approval) |
| DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE |
219755 |
002 |
ANDA |
DAPAGLIFLOZIN, METFORMIN HYDROCHLORIDE |
TABLET, EXTENDED RELEASE |
10MG |
No
|
No
|
2026/01/29
(TA)
|
--
|
INVENTIA HEALTHCARE LIMITED |
None (Tentative Approval) |
| DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE |
219755 |
003 |
ANDA |
DAPAGLIFLOZIN, METFORMIN HYDROCHLORIDE |
TABLET, EXTENDED RELEASE |
5MG |
No
|
No
|
2026/01/29
(TA)
|
--
|
INVENTIA HEALTHCARE LIMITED |
None (Tentative Approval) |
| DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE |
219755 |
004 |
ANDA |
DAPAGLIFLOZIN, METFORMIN HYDROCHLORIDE |
TABLET, EXTENDED RELEASE |
500MG |
No
|
No
|
2026/01/29
(TA)
|
--
|
INVENTIA HEALTHCARE LIMITED |
None (Tentative Approval) |
| DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE |
219755 |
005 |
ANDA |
DAPAGLIFLOZIN, METFORMIN HYDROCHLORIDE |
TABLET, EXTENDED RELEASE |
2.5MG |
No
|
No
|
2026/01/29
(TA)
|
--
|
INVENTIA HEALTHCARE LIMITED |
None (Tentative Approval) |