| EMPAGLIFLOZIN; METFORMIN HYDROCHLORIDE |
212373 |
003 |
ANDA |
EMPAGLIFLOZIN;METFORMIN HYDROCHLORIDE |
TABLET;ORAL |
12.5MG;500MG |
No
|
No
|
2025/07/16
(TA)
|
--
|
MACLEODS PHARMS LTD |
None (Tentative Approval) |
| EMPAGLIFLOZIN; METFORMIN HYDROCHLORIDE |
212373 |
004 |
ANDA |
EMPAGLIFLOZIN;METFORMIN HYDROCHLORIDE |
TABLET;ORAL |
12.5MG;1000MG |
No
|
No
|
2025/07/16
(TA)
|
--
|
MACLEODS PHARMS LTD |
None (Tentative Approval) |
| SITAGLIPTIN AND METFORMIN HYDROCHLORIDE |
216516 |
002 |
ANDA |
METFORMIN HYDROCHLORIDE, SITAGLIPTIN |
TABLET |
50MG |
No
|
No
|
2025/07/24
(TA)
|
--
|
AJANTA PHARMA LTD |
None (Tentative Approval) |
| SITAGLIPTIN AND METFORMIN HYDROCHLORIDE |
216516 |
003 |
ANDA |
METFORMIN HYDROCHLORIDE, SITAGLIPTIN |
TABLET |
1000MG |
No
|
No
|
2025/07/24
(TA)
|
--
|
AJANTA PHARMA LTD |
None (Tentative Approval) |
| SITAGLIPTIN AND METFORMIN HYDROCHLORIDE |
219296 |
002 |
ANDA |
METFORMIN HYDROCHLORIDE, SITAGLIPTIN |
TABLET, EXTENDED RELEASE |
EQ 100MG BASE TABLET |
No
|
No
|
2025/08/12
(TA)
|
--
|
FOSUN WANBANG (JIANGSU) PHARMACEUTICAL GROUP CO., |
None (Tentative Approval) |
| SITAGLIPTIN AND METFORMIN HYDROCHLORIDE |
219296 |
003 |
ANDA |
METFORMIN HYDROCHLORIDE, SITAGLIPTIN |
TABLET, EXTENDED RELEASE |
500MG |
No
|
No
|
2025/08/12
(TA)
|
--
|
FOSUN WANBANG (JIANGSU) PHARMACEUTICAL GROUP CO., |
None (Tentative Approval) |
| SITAGLIPTIN AND METFORMIN HYDROCHLORIDE |
219296 |
004 |
ANDA |
METFORMIN HYDROCHLORIDE, SITAGLIPTIN |
TABLET, EXTENDED RELEASE |
50MG |
No
|
No
|
2025/08/12
(TA)
|
--
|
FOSUN WANBANG (JIANGSU) PHARMACEUTICAL GROUP CO., |
None (Tentative Approval) |
| SITAGLIPTIN AND METFORMIN HYDROCHLORIDE |
219296 |
005 |
ANDA |
METFORMIN HYDROCHLORIDE, SITAGLIPTIN |
TABLET, EXTENDED RELEASE |
1000MG |
No
|
No
|
2025/08/12
(TA)
|
--
|
FOSUN WANBANG (JIANGSU) PHARMACEUTICAL GROUP CO., |
None (Tentative Approval) |
| 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) |
| CANAGLIFLOZIN AND METFORMIN HYDROCHLORIDE |
215255 |
001 |
ANDA |
METFORMIN HYDROCHLORIDE; CANAGLIFLOZIN |
TABLET, EXTENDED RELEASE |
1000MG |
No
|
No
|
2025/10/01
(TA)
|
--
|
MACLEODS PHARMACEUTICALS LTD |
None (Tentative Approval) |
| CANAGLIFLOZIN AND METFORMIN HYDROCHLORIDE |
215255 |
002 |
ANDA |
METFORMIN HYDROCHLORIDE; CANAGLIFLOZIN |
TABLET, EXTENDED RELEASE |
50MG |
No
|
No
|
2025/10/01
(TA)
|
--
|
MACLEODS PHARMACEUTICALS LTD |
None (Tentative Approval) |
| CANAGLIFLOZIN AND METFORMIN HYDROCHLORIDE |
215255 |
003 |
ANDA |
METFORMIN HYDROCHLORIDE; CANAGLIFLOZIN |
TABLET, EXTENDED RELEASE |
150MG |
No
|
No
|
2025/10/01
(TA)
|
--
|
MACLEODS PHARMACEUTICALS LTD |
None (Tentative Approval) |
| CANAGLIFLOZIN AND METFORMIN HYDROCHLORIDE |
215255 |
004 |
ANDA |
METFORMIN HYDROCHLORIDE; CANAGLIFLOZIN |
TABLET, EXTENDED RELEASE |
500MG |
No
|
No
|
2025/10/01
(TA)
|
--
|
MACLEODS PHARMACEUTICALS LTD |
None (Tentative Approval) |
| SITAGLIPTIN AND METFORMIN HYDROCHLORIDE |
212869 |
002 |
ANDA |
SITAGLIPTIN, METFORMIN HYDROCHLORIDE |
TABLET, EXTENDED RELEASE |
100MG |
No
|
No
|
2025/10/15
(TA)
|
--
|
SINOTHERAPEUTICS INC |
None (Tentative Approval) |
| SITAGLIPTIN AND METFORMIN HYDROCHLORIDE |
212869 |
003 |
ANDA |
SITAGLIPTIN, METFORMIN HYDROCHLORIDE |
TABLET, EXTENDED RELEASE |
500MG |
No
|
No
|
2025/10/15
(TA)
|
--
|
SINOTHERAPEUTICS INC |
None (Tentative Approval) |
| SITAGLIPTIN AND METFORMIN HYDROCHLORIDE |
212869 |
004 |
ANDA |
SITAGLIPTIN, METFORMIN HYDROCHLORIDE |
TABLET, EXTENDED RELEASE |
50MG |
No
|
No
|
2025/10/15
(TA)
|
--
|
SINOTHERAPEUTICS INC |
None (Tentative Approval) |
| LINAGLIPTIN AND METFORMIN HYDROCHLORIDE |
208427 |
001 |
ANDA |
LINAGLIPTIN; METFORMIN HYDROCHLORIDE |
TABLET;ORAL |
2.5MG;500MG |
No
|
No
|
2025/11/03
|
2025/11/03
|
DR REDDYS |
Prescription |