SITAGLIPTIN PHOSPHATE; METFORMIN HYDROCHLORIDE |
204591 |
003 |
ANDA |
SITAGLIPTIN PHOSPHATE;METFORMIN HYDROCHLORIDE |
TABLET, EXTENDED RELEASE;ORAL |
100MG;1000MG |
No
|
No
|
2015/09/29
(TA)
|
--
|
TEVA PHARMS USA INC |
None (Tentative Approval) |
SITAGLIPTIN PHOSPHATE; METFORMIN HYDROCHLORIDE |
202365 |
001 |
ANDA |
SITAGLIPTIN PHOSPHATE; METFORMIN HYDROCHLORIDE |
TABLET;ORAL |
50MG;500MG |
No
|
No
|
2015/10/30
(TA)
|
--
|
WATSON LABS INC |
None (Tentative Approval) |
SITAGLIPTIN PHOSPHATE; METFORMIN HYDROCHLORIDE |
202365 |
002 |
ANDA |
SITAGLIPTIN PHOSPHATE; METFORMIN HYDROCHLORIDE |
TABLET;ORAL |
50MG;1000MG |
No
|
No
|
2015/10/30
(TA)
|
--
|
WATSON LABS INC |
None (Tentative Approval) |
METFORMIN HYDROCHLORIDE AND SITAGLIPTIN PHOSPHATE |
208535 |
001 |
ANDA |
METFORMIN HYDROCHLORIDE;SITAGLIPTIN PHOSPHATE |
TABLET;ORAL |
50MG/500MG;50MG/1000MG |
No
|
No
|
2017/07/03
(TA)
|
--
|
ZYDUS PHARMS USA INC |
None (Tentative Approval) |
SITAGLIPTIN PHOSPHATE |
208186 |
001 |
ANDA |
SITAGLIPTIN PHOSPHATE |
TABLET;ORAL |
EQ 25MG BASE |
No
|
No
|
2018/09/07
(TA)
|
--
|
ZYDUS PHARMS USA INC |
None (Tentative Approval) |
SITAGLIPTIN PHOSPHATE |
208186 |
002 |
ANDA |
SITAGLIPTIN PHOSPHATE |
TABLET;ORAL |
EQ 50MG BASE |
No
|
No
|
2018/09/07
(TA)
|
--
|
ZYDUS PHARMS USA INC |
None (Tentative Approval) |
SITAGLIPTIN PHOSPHATE |
208186 |
003 |
ANDA |
SITAGLIPTIN PHOSPHATE |
TABLET;ORAL |
EQ 100MG BASE |
No
|
No
|
2018/09/07
(TA)
|
--
|
ZYDUS PHARMS USA INC |
None (Tentative Approval) |
SITAGLIPTIN PHOSPHATE |
214784 |
001 |
ANDA |
SITAGLIPTIN PHOSPHATE |
TABLET;ORAL |
EQ 25MG BASE |
No
|
No
|
2021/01/05
(TA)
|
--
|
AJANTA PHARMA LTD |
None (Tentative Approval) |
SITAGLIPTIN PHOSPHATE |
214784 |
002 |
ANDA |
SITAGLIPTIN PHOSPHATE |
TABLET;ORAL |
EQ 50MG BASE |
No
|
No
|
2021/01/05
(TA)
|
--
|
AJANTA PHARMA LTD |
None (Tentative Approval) |
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 |
202387 |
001 |
ANDA |
SITAGLIPTIN PHOSPHATE |
TABLET; ORAL |
EQ 25MG BASE |
No
|
No
|
2021/12/27
(TA)
|
--
|
SANDOZ INC |
None (Tentative Approval) |
SITAGLIPTIN PHOSPHATE |
202387 |
002 |
ANDA |
SITAGLIPTIN PHOSPHATE |
TABLET; ORAL |
EQ 50MG BASE |
No
|
No
|
2021/12/27
(TA)
|
--
|
SANDOZ INC |
None (Tentative Approval) |
SITAGLIPTIN PHOSPHATE |
202387 |
003 |
ANDA |
SITAGLIPTIN PHOSPHATE |
TABLET; ORAL |
EQ 100MG BASE |
No
|
No
|
2021/12/27
(TA)
|
--
|
SANDOZ INC |
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) |