| DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE |
211489 |
005 |
ANDA |
DAPAGLIFLOZIN, METFORMIN HYDROCHLORIDE |
TABLET |
2.5MG |
No
|
No
|
2026/04/06
|
--
|
AUROBINDO PHARMA |
None (Tentative Approval) |
| DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE |
211491 |
001 |
ANDA |
DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE |
TABLET, EXTENDED RELEASE;ORAL |
5MG;1GM |
No
|
No
|
2026/04/06
|
2026/04/06
|
SUN PHARM |
Prescription |
| DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE |
211491 |
001 |
ANDA |
DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE |
TABLET, EXTENDED RELEASE;ORAL |
5MG;1GM |
No
|
No
|
2026/04/06
(TA)
|
2026/04/06
|
SUN PHARM |
Prescription |
| DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE |
211491 |
002 |
ANDA |
DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE |
TABLET, EXTENDED RELEASE;ORAL |
10MG;500MG |
No
|
No
|
2026/04/06
|
2026/04/06
|
SUN PHARM |
Prescription |
| DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE |
211491 |
002 |
ANDA |
DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE |
TABLET, EXTENDED RELEASE;ORAL |
10MG;500MG |
No
|
No
|
2026/04/06
(TA)
|
2026/04/06
|
SUN PHARM |
Prescription |
| DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE |
211491 |
003 |
ANDA |
DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE |
TABLET, EXTENDED RELEASE;ORAL |
10MG;1GM |
No
|
No
|
2026/04/06
|
2026/04/06
|
SUN PHARM |
Prescription |
| DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE |
211491 |
003 |
ANDA |
DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE |
TABLET, EXTENDED RELEASE;ORAL |
10MG;1GM |
No
|
No
|
2026/04/06
(TA)
|
2026/04/06
|
SUN PHARM |
Prescription |
| DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE |
211536 |
001 |
ANDA |
DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE |
TABLET, EXTENDED RELEASE;ORAL |
5MG;500MG |
No
|
No
|
2026/04/06
|
2026/04/06
|
CIPLA LTD |
Prescription |
| DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE |
211536 |
002 |
ANDA |
DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE |
TABLET, EXTENDED RELEASE;ORAL |
10MG;500MG |
No
|
No
|
2026/04/06
|
2026/04/06
|
CIPLA LTD |
Prescription |
| DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE |
211536 |
003 |
ANDA |
DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE |
TABLET, EXTENDED RELEASE;ORAL |
10MG;1GM |
No
|
No
|
2026/04/06
|
2026/04/06
|
CIPLA LTD |
Prescription |
| DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE |
211559 |
001 |
ANDA |
DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE |
TABLET, EXTENDED RELEASE;ORAL |
5MG;500MG |
No
|
No
|
2026/04/06
|
2026/04/06
|
MACLEODS PHARMS LTD |
Prescription |
| DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE |
211559 |
002 |
ANDA |
DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE |
TABLET, EXTENDED RELEASE;ORAL |
5MG;1GM |
No
|
No
|
2026/04/06
|
2026/04/06
|
MACLEODS PHARMS LTD |
Prescription |
| DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE |
211559 |
003 |
ANDA |
DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE |
TABLET, EXTENDED RELEASE;ORAL |
10MG;500MG |
No
|
No
|
2026/04/06
|
2026/04/06
|
MACLEODS PHARMS LTD |
Prescription |
| DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE |
211559 |
004 |
ANDA |
DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE |
TABLET, EXTENDED RELEASE;ORAL |
10MG;1GM |
No
|
No
|
2026/04/06
|
2026/04/06
|
MACLEODS PHARMS LTD |
Prescription |
| DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE |
211563 |
001 |
ANDA |
DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE |
TABLET, EXTENDED RELEASE;ORAL |
5MG;500MG |
No
|
No
|
2026/04/06
|
2026/04/06
|
ALKEM LABS LTD |
Prescription |
| DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE |
211563 |
001 |
ANDA |
DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE |
TABLET, EXTENDED RELEASE;ORAL |
5MG;500MG |
No
|
No
|
2026/04/06
(TA)
|
2026/04/06
|
ALKEM LABS LTD |
Prescription |
| DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE |
211563 |
002 |
ANDA |
DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE |
TABLET, EXTENDED RELEASE;ORAL |
5MG;1GM |
No
|
No
|
2026/04/06
|
2026/04/06
|
ALKEM LABS LTD |
Prescription |
| DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE |
211563 |
002 |
ANDA |
DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE |
TABLET, EXTENDED RELEASE;ORAL |
5MG;1GM |
No
|
No
|
2026/04/06
(TA)
|
2026/04/06
|
ALKEM LABS LTD |
Prescription |
| DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE |
211563 |
003 |
ANDA |
DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE |
TABLET, EXTENDED RELEASE;ORAL |
10MG;500MG |
No
|
No
|
2026/04/06
|
2026/04/06
|
ALKEM LABS LTD |
Prescription |
| DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE |
211563 |
003 |
ANDA |
DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE |
TABLET, EXTENDED RELEASE;ORAL |
10MG;500MG |
No
|
No
|
2026/04/06
(TA)
|
2026/04/06
|
ALKEM LABS LTD |
Prescription |