| DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE |
211563 |
004 |
ANDA |
DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE |
TABLET, EXTENDED RELEASE;ORAL |
10MG;1GM |
No
|
No
|
2026/04/06
|
2026/04/06
|
ALKEM LABS LTD |
Prescription |
| DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE |
211563 |
004 |
ANDA |
DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE |
TABLET, EXTENDED RELEASE;ORAL |
10MG;1GM |
No
|
No
|
2026/04/06
(TA)
|
2026/04/06
|
ALKEM LABS LTD |
Prescription |
| DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE |
211579 |
001 |
ANDA |
DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE |
TABLET, EXTENDED RELEASE;ORAL |
5MG;500MG |
No
|
No
|
2026/04/06
|
2026/04/06
|
LUPIN |
Prescription |
| DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE |
211579 |
001 |
ANDA |
DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE |
TABLET, EXTENDED RELEASE;ORAL |
5MG;500MG |
No
|
No
|
2026/04/06
(TA)
|
2026/04/06
|
LUPIN |
Prescription |
| DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE |
211579 |
002 |
ANDA |
DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE |
TABLET, EXTENDED RELEASE;ORAL |
5MG;1GM |
No
|
No
|
2026/04/06
|
2026/04/06
|
LUPIN |
Prescription |
| DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE |
211579 |
002 |
ANDA |
DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE |
TABLET, EXTENDED RELEASE;ORAL |
5MG;1GM |
No
|
No
|
2026/04/06
(TA)
|
2026/04/06
|
LUPIN |
Prescription |
| DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE |
211579 |
003 |
ANDA |
DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE |
TABLET, EXTENDED RELEASE;ORAL |
10MG;500MG |
No
|
No
|
2026/04/06
|
2026/04/06
|
LUPIN |
Prescription |
| DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE |
211579 |
003 |
ANDA |
DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE |
TABLET, EXTENDED RELEASE;ORAL |
10MG;500MG |
No
|
No
|
2026/04/06
(TA)
|
2026/04/06
|
LUPIN |
Prescription |
| DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE |
211579 |
004 |
ANDA |
DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE |
TABLET, EXTENDED RELEASE;ORAL |
10MG;1GM |
No
|
No
|
2026/04/06
|
2026/04/06
|
LUPIN |
Prescription |
| DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE |
211579 |
004 |
ANDA |
DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE |
TABLET, EXTENDED RELEASE;ORAL |
10MG;1GM |
No
|
No
|
2026/04/06
(TA)
|
2026/04/06
|
LUPIN |
Prescription |
| DAPAGLIFLOZIN |
211582 |
001 |
ANDA |
DAPAGLIFLOZIN |
TABLET;ORAL |
5MG |
No
|
No
|
2026/04/06
|
2026/04/06
|
ZYDUS PHARMS |
Prescription |
| DAPAGLIFLOZIN |
211582 |
002 |
ANDA |
DAPAGLIFLOZIN |
TABLET;ORAL |
10MG |
No
|
No
|
2026/04/06
|
2026/04/06
|
ZYDUS PHARMS |
Prescription |
| DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE |
211583 |
001 |
ANDA |
DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE |
TABLET, EXTENDED RELEASE;ORAL |
2.5MG;1GM |
No
|
No
|
2026/04/06
|
2026/04/06
|
TEVA PHARMS USA INC |
Prescription |
| DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE |
211583 |
002 |
ANDA |
DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE |
TABLET, EXTENDED RELEASE;ORAL |
5MG;500MG |
No
|
No
|
2026/04/06
|
2026/04/06
|
TEVA PHARMS USA INC |
Prescription |
| DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE |
211583 |
003 |
ANDA |
DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE |
TABLET, EXTENDED RELEASE;ORAL |
5MG;1GM |
No
|
No
|
2026/04/06
|
2026/04/06
|
TEVA PHARMS USA INC |
Prescription |
| DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE |
211583 |
004 |
ANDA |
DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE |
TABLET, EXTENDED RELEASE;ORAL |
10MG;500MG |
No
|
No
|
2026/04/06
|
2026/04/06
|
TEVA PHARMS USA INC |
Prescription |
| DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE |
211583 |
005 |
ANDA |
DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE |
TABLET, EXTENDED RELEASE;ORAL |
10MG;1GM |
No
|
No
|
2026/04/06
|
2026/04/06
|
TEVA PHARMS USA INC |
Prescription |
| DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE |
211595 |
001 |
ANDA |
DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE |
TABLET, EXTENDED RELEASE;ORAL |
5MG;1GM |
No
|
No
|
2026/04/06
|
2026/04/06
|
CIPLA |
Prescription |
| DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE |
219755 |
002 |
ANDA |
DAPAGLIFLOZIN, METFORMIN HYDROCHLORIDE |
TABLET, EXTENDED RELEASE |
10MG |
No
|
No
|
2026/04/09
(TA)
|
--
|
INVENTIA HEALTHCARE LIMITED |
None (Tentative Approval) |
| DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE |
219755 |
003 |
ANDA |
DAPAGLIFLOZIN, METFORMIN HYDROCHLORIDE |
TABLET, EXTENDED RELEASE |
5MG |
No
|
No
|
2026/04/09
(TA)
|
--
|
INVENTIA HEALTHCARE LIMITED |
None (Tentative Approval) |