| SITAGLIPTIN AND METFORMIN HYDROCHLORIDE |
215220 |
002 |
ANDA |
SITAGLIPTIN; METFORMIN HYDROCHLORIDE |
TABLET; ORAL |
50MG/1000MG |
No
|
No
|
2022/05/31
(TA)
|
--
|
AJANTA PHARMA LTD |
None (Tentative Approval) |
| SITAGLIPTIN AND METFORMIN HYDROCHLORIDE |
218069 |
002 |
ANDA |
METFORMIN HYDROCHLORIDE, SITAGLIPTIN |
TABLET, EXTENDED RELEASE |
EQ 100MG BASE TABLET |
No
|
No
|
2025/05/28
(TA)
|
--
|
NOVAST LABS LTD |
None (Tentative Approval) |
| SITAGLIPTIN AND METFORMIN HYDROCHLORIDE |
218069 |
003 |
ANDA |
METFORMIN HYDROCHLORIDE, SITAGLIPTIN |
TABLET, EXTENDED RELEASE |
500MG |
No
|
No
|
2025/05/28
(TA)
|
--
|
NOVAST LABS LTD |
None (Tentative Approval) |
| SITAGLIPTIN AND METFORMIN HYDROCHLORIDE |
218069 |
004 |
ANDA |
METFORMIN HYDROCHLORIDE, SITAGLIPTIN |
TABLET, EXTENDED RELEASE |
50MG |
No
|
No
|
2025/05/28
(TA)
|
--
|
NOVAST LABS LTD |
None (Tentative Approval) |
| SITAGLIPTIN AND METFORMIN HYDROCHLORIDE |
218069 |
005 |
ANDA |
METFORMIN HYDROCHLORIDE, SITAGLIPTIN |
TABLET, EXTENDED RELEASE |
1000MG |
No
|
No
|
2025/05/28
(TA)
|
--
|
NOVAST LABS LTD |
None (Tentative Approval) |
| SITAGLIPTIN AND METFORMIN HYDROCHLORIDE |
204144 |
001 |
ANDA |
METFORMIN HYDROCHLORIDE; SITAGLIPTIN PHOSPHATE |
TABLET, EXTENDED RELEASE;ORAL |
500MG;EQ 50MG BASE |
No
|
No
|
2025/06/04
|
2025/06/04
|
PH HEALTH |
Discontinued |
| SITAGLIPTIN AND METFORMIN HYDROCHLORIDE |
204144 |
002 |
ANDA |
METFORMIN HYDROCHLORIDE; SITAGLIPTIN PHOSPHATE |
TABLET, EXTENDED RELEASE;ORAL |
1GM;EQ 50MG BASE |
No
|
No
|
2025/06/04
|
2025/06/04
|
PH HEALTH |
Discontinued |
| SITAGLIPTIN AND METFORMIN HYDROCHLORIDE |
204144 |
003 |
ANDA |
METFORMIN HYDROCHLORIDE; SITAGLIPTIN PHOSPHATE |
TABLET, EXTENDED RELEASE;ORAL |
1GM;EQ 100MG BASE |
No
|
No
|
2025/06/04
|
2025/06/04
|
PH HEALTH |
Discontinued |
| SITAGLIPTIN AND METFORMIN HYDROCHLORIDE |
216288 |
002 |
ANDA |
METFORMIN HYDROCHLORIDE, SITAGLIPTIN |
TABLET, COATED |
50MG |
No
|
No
|
2025/07/14
(TA)
|
--
|
MSN LABORATORIES PRIVATE LTD |
None (Tentative Approval) |
| SITAGLIPTIN AND METFORMIN HYDROCHLORIDE |
216288 |
003 |
ANDA |
METFORMIN HYDROCHLORIDE, SITAGLIPTIN |
TABLET, COATED |
500MG |
No
|
No
|
2025/07/14
(TA)
|
--
|
MSN LABORATORIES PRIVATE 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) |
| 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) |
| SITAGLIPTIN AND METFORMIN HYDROCHLORIDE |
217395 |
002 |
ANDA |
SITAGLIPTIN PHOSPHATE ANHYDROUS, METFORMIN HYDROCHLORIDE |
TABLET |
100MG |
No
|
No
|
2025/11/17
(TA)
|
--
|
MSN LABORATORIES PRIVATE LTD |
None (Tentative Approval) |