| SITAGLIPTIN AND METFORMIN HYDROCHLORIDE |
214494 |
002 |
ANDA |
METFORMIN HYDROCHLORIDE, SITAGLIPTIN |
TABLET, EXTENDED RELEASE |
100MG |
No
|
No
|
2026/03/10
(TA)
|
--
|
APOTEX INC |
None (Tentative Approval) |
| SITAGLIPTIN AND METFORMIN HYDROCHLORIDE |
214494 |
003 |
ANDA |
METFORMIN HYDROCHLORIDE, SITAGLIPTIN |
TABLET, EXTENDED RELEASE |
50MG |
No
|
No
|
2026/03/10
(TA)
|
--
|
APOTEX INC |
None (Tentative Approval) |
| SITAGLIPTIN AND METFORMIN HYDROCHLORIDE |
214494 |
004 |
ANDA |
METFORMIN HYDROCHLORIDE, SITAGLIPTIN |
TABLET, EXTENDED RELEASE |
500MG |
No
|
No
|
2026/03/10
(TA)
|
--
|
APOTEX INC |
None (Tentative Approval) |
| SITAGLIPTIN AND METFORMIN HYDROCHLORIDE |
217829 |
002 |
ANDA |
SITAGLIPTIN, METFORMIN HYDROCHLORIDE |
TABLET, EXTENDED RELEASE |
500MG |
No
|
No
|
2026/03/25
(TA)
|
--
|
INVENTIA HEALTHCARE LIMITED |
None (Tentative Approval) |
| SITAGLIPTIN AND METFORMIN HYDROCHLORIDE |
217829 |
003 |
ANDA |
SITAGLIPTIN, METFORMIN HYDROCHLORIDE |
TABLET, EXTENDED RELEASE |
50MG |
No
|
No
|
2026/03/25
(TA)
|
--
|
INVENTIA HEALTHCARE LIMITED |
None (Tentative Approval) |
| SITAGLIPTIN AND METFORMIN HYDROCHLORIDE |
217829 |
004 |
ANDA |
SITAGLIPTIN, METFORMIN HYDROCHLORIDE |
TABLET, EXTENDED RELEASE |
100MG |
No
|
No
|
2026/03/25
(TA)
|
--
|
INVENTIA HEALTHCARE LIMITED |
None (Tentative Approval) |
| DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE |
211466 |
001 |
ANDA |
DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE |
TABLET, EXTENDED RELEASE;ORAL |
5MG;500MG |
No
|
No
|
2026/04/06
|
2026/04/06
|
MICRO LABS |
Prescription |
| DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE |
211466 |
001 |
ANDA |
DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE |
TABLET, EXTENDED RELEASE;ORAL |
5MG;500MG |
No
|
No
|
2026/04/06
(TA)
|
2026/04/06
|
MICRO LABS |
Prescription |
| DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE |
211466 |
002 |
ANDA |
DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE |
TABLET, EXTENDED RELEASE;ORAL |
5MG;1GM |
No
|
No
|
2026/04/06
|
2026/04/06
|
MICRO LABS |
Prescription |
| DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE |
211466 |
002 |
ANDA |
DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE |
TABLET, EXTENDED RELEASE;ORAL |
5MG;1GM |
No
|
No
|
2026/04/06
(TA)
|
2026/04/06
|
MICRO LABS |
Prescription |
| DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE |
211466 |
003 |
ANDA |
DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE |
TABLET, EXTENDED RELEASE;ORAL |
10MG;500MG |
No
|
No
|
2026/04/06
|
2026/04/06
|
MICRO LABS |
Prescription |
| DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE |
211466 |
003 |
ANDA |
DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE |
TABLET, EXTENDED RELEASE;ORAL |
10MG;500MG |
No
|
No
|
2026/04/06
(TA)
|
2026/04/06
|
MICRO LABS |
Prescription |
| DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE |
211466 |
004 |
ANDA |
DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE |
TABLET, EXTENDED RELEASE;ORAL |
10MG;1GM |
No
|
No
|
2026/04/06
|
2026/04/06
|
MICRO LABS |
Prescription |
| DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE |
211466 |
004 |
ANDA |
DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE |
TABLET, EXTENDED RELEASE;ORAL |
10MG;1GM |
No
|
No
|
2026/04/06
(TA)
|
2026/04/06
|
MICRO LABS |
Prescription |
| DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE |
211479 |
001 |
ANDA |
DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE |
TABLET, EXTENDED RELEASE;ORAL |
5MG;500MG |
No
|
No
|
2026/04/06
|
2026/04/06
|
MSN |
Prescription |
| DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE |
211479 |
002 |
ANDA |
DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE |
TABLET, EXTENDED RELEASE;ORAL |
5MG;1GM |
No
|
No
|
2026/04/06
|
2026/04/06
|
MSN |
Prescription |
| DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE |
211479 |
003 |
ANDA |
DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE |
TABLET, EXTENDED RELEASE;ORAL |
10MG;500MG |
No
|
No
|
2026/04/06
|
2026/04/06
|
MSN |
Prescription |
| DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE |
211479 |
004 |
ANDA |
DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE |
TABLET, EXTENDED RELEASE;ORAL |
10MG;1GM |
No
|
No
|
2026/04/06
|
2026/04/06
|
MSN |
Prescription |
| DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE |
211489 |
001 |
ANDA |
DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE |
TABLET, EXTENDED RELEASE;ORAL |
5MG;500MG |
No
|
No
|
2026/04/06
|
2026/04/06
|
AUROBINDO PHARMA |
Prescription |
| DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE |
211489 |
002 |
ANDA |
DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE |
TABLET, EXTENDED RELEASE;ORAL |
5MG;1GM |
No
|
No
|
2026/04/06
|
2026/04/06
|
AUROBINDO PHARMA |
Prescription |