| SITAGLIPTIN PHOSPHATE |
214784 |
003 |
ANDA |
SITAGLIPTIN PHOSPHATE |
TABLET;ORAL |
EQ 100MG BASE |
No
|
No
|
2021/01/05
(TA)
|
--
|
AJANTA PHARMA LTD |
None (Tentative Approval) |
| SITAGLIPTIN PHOSPHATE |
214693 |
001 |
ANDA |
SITAGLIPTIN PHOSPHATE |
TABLET;ORAL |
EQ 25MG BASE |
No
|
No
|
2021/07/09
(TA)
|
--
|
UNICHEM LABS LTD |
None (Tentative Approval) |
| SITAGLIPTIN PHOSPHATE |
214693 |
002 |
ANDA |
SITAGLIPTIN PHOSPHATE |
TABLET;ORAL |
EQ 50MG BASE |
No
|
No
|
2021/07/09
(TA)
|
--
|
UNICHEM LABS LTD |
None (Tentative Approval) |
| SITAGLIPTIN PHOSPHATE |
214693 |
003 |
ANDA |
SITAGLIPTIN PHOSPHATE |
TABLET;ORAL |
EQ 100MG BASE |
No
|
No
|
2021/07/09
(TA)
|
--
|
UNICHEM LABS LTD |
None (Tentative Approval) |
| SITAGLIPTIN PHOSPHATE |
215155 |
002 |
ANDA |
SITAGLIPTIN PHOSPHATE |
TABLET;ORAL |
EQ 50MG BASE |
No
|
No
|
2022/04/08
(TA)
|
--
|
ALKEM LABS LTD |
None (Tentative Approval) |
| SITAGLIPTIN PHOSPHATE |
215155 |
003 |
ANDA |
SITAGLIPTIN PHOSPHATE |
TABLET;ORAL |
EQ 100MG BASE |
No
|
No
|
2022/04/08
(TA)
|
--
|
ALKEM LABS LTD |
None (Tentative Approval) |
| METFORMIN HYDROCHLORIDE AND SITAGLIPTIN PHOSPHATE |
212338 |
001 |
ANDA |
METFORMIN HYDROCHLORIDE || SITAGLIPTIN |
TABLET:FILM COATED |
50MG |
No
|
No
|
2025/01/07
(TA)
|
--
|
MACLEODS PHARMS LTD |
None (Tentative Approval) |
| METFORMIN HYDROCHLORIDE AND SITAGLIPTIN PHOSPHATE |
212338 |
002 |
ANDA |
METFORMIN HYDROCHLORIDE || SITAGLIPTIN |
TABLET;FILM COATED |
500MG |
No
|
No
|
2025/01/07
(TA)
|
--
|
MACLEODS PHARMS LTD |
None (Tentative Approval) |
| METFORMIN HYDROCHLORIDE AND SITAGLIPTIN PHOSPHATE |
212338 |
003 |
ANDA |
METFORMIN HYDROCHLORIDE || SITAGLIPTIN |
TABLET;FILM COATED |
1000MG |
No
|
No
|
2025/01/07
(TA)
|
--
|
MACLEODS PHARMS LTD |
None (Tentative Approval) |
| SITAGLIPTIN PHOSPHATE AND METFORMIN HYDROCHLORIDE |
216885 |
001 |
ANDA |
METFORMIN HYDROCHLORIDE, SITAGLIPTIN PHOSPHATE |
TABLET;FILM COATED |
1000MG |
No
|
No
|
2025/03/13
(TA)
|
--
|
PRINSTON PHARMACEUTICAL INC |
None (Tentative Approval) |
| SITAGLIPTIN PHOSPHATE AND METFORMIN HYDROCHLORIDE |
216885 |
002 |
ANDA |
METFORMIN HYDROCHLORIDE, SITAGLIPTIN PHOSPHATE |
TABLET;FILM COATED |
50MG |
No
|
No
|
2025/03/13
(TA)
|
--
|
PRINSTON PHARMACEUTICAL INC |
None (Tentative Approval) |
| SITAGLIPTIN PHOSPHATE AND METFORMIN HYDROCHLORIDE |
216885 |
003 |
ANDA |
METFORMIN HYDROCHLORIDE, SITAGLIPTIN PHOSPHATE |
TABLET;FILM COATED |
500MG |
No
|
No
|
2025/03/13
(TA)
|
--
|
PRINSTON PHARMACEUTICAL INC |
None (Tentative Approval) |
| SITAGLIPTIN PHOSPHATE |
211073 |
001 |
ANDA |
SITAGLIPTIN PHOSPHATE |
TABLET; ORAL |
25MG |
TBD
|
No
|
2025/04/02
(TA)
|
--
|
MACLEODS PHARMS LTD |
None (Tentative Approval) |
| SITAGLIPTIN PHOSPHATE |
211073 |
002 |
ANDA |
SITAGLIPTIN PHOSPHATE |
TABLET; ORAL |
50MG |
TBD
|
No
|
2025/04/02
(TA)
|
--
|
MACLEODS PHARMS LTD |
None (Tentative Approval) |
| SITAGLIPTIN PHOSPHATE |
211073 |
003 |
ANDA |
SITAGLIPTIN PHOSPHATE |
TABLET; ORAL |
100MG |
TBD
|
No
|
2025/04/02
(TA)
|
--
|
MACLEODS PHARMS LTD |
None (Tentative Approval) |
| SITAGLIPTIN PHOSPHATE |
214700 |
001 |
ANDA |
SITAGLIPTIN PHOSPHATE |
TABLET;FILM COATED |
25MG |
No
|
No
|
2025/05/12
(TA)
|
--
|
DR REDDYS LABS LTD |
None (Tentative Approval) |
| SITAGLIPTIN PHOSPHATE |
214700 |
002 |
ANDA |
SITAGLIPTIN PHOSPHATE |
TABLET;FILM COATED |
50MG |
No
|
No
|
2025/05/12
(TA)
|
--
|
DR REDDYS LABS LTD |
None (Tentative Approval) |
| SITAGLIPTIN PHOSPHATE |
214700 |
003 |
ANDA |
SITAGLIPTIN PHOSPHATE |
TABLET;FILM COATED |
100MG |
No
|
No
|
2025/05/12
(TA)
|
--
|
DR REDDYS LABS LTD |
None (Tentative Approval) |
| SITAGLIPTIN PHOSPHATE |
202327 |
001 |
ANDA |
SITAGLIPTIN PHOSPHATE |
TABLET;ORAL |
EQ 25MG BASE |
No
|
No
|
2025/12/29
|
2025/12/30
|
WATSON LABS INC |
Prescription |
| SITAGLIPTIN PHOSPHATE |
202327 |
002 |
ANDA |
SITAGLIPTIN PHOSPHATE |
TABLET;ORAL |
EQ 50MG BASE |
No
|
No
|
2025/12/29
|
2025/12/30
|
WATSON LABS INC |
Prescription |