| SITAGLIPTIN PHOSPHATE |
202473 |
001 |
ANDA |
SITAGLIPTIN PHOSPHATE |
TABLET; ORAL |
EQ 25MG BASE |
No
|
No
|
2012/10/10
(TA)
|
--
|
MYLAN PHARMS INC |
None (Tentative Approval) |
| SITAGLIPTIN PHOSPHATE |
202473 |
002 |
ANDA |
SITAGLIPTIN PHOSPHATE |
TABLET; ORAL |
EQ 50MG BASE |
No
|
No
|
2012/10/10
(TA)
|
--
|
MYLAN PHARMS INC |
None (Tentative Approval) |
| SITAGLIPTIN PHOSPHATE |
202473 |
003 |
ANDA |
SITAGLIPTIN PHOSPHATE |
TABLET; ORAL |
EQ 100MG BASE |
No
|
No
|
2012/10/10
(TA)
|
--
|
MYLAN PHARMS INC |
None (Tentative Approval) |
| SITAGLIPTIN PHOSPHATE |
202423 |
001 |
ANDA |
SITAGLIPTIN PHOSPHATE |
TABLET; ORAL |
25MG |
No
|
No
|
2013/04/11
(TA)
|
--
|
SUN PHARMA GLOBAL |
None (Tentative Approval) |
| SITAGLIPTIN PHOSPHATE |
202423 |
002 |
ANDA |
SITAGLIPTIN PHOSPHATE |
TABLET; ORAL |
50MG |
No
|
No
|
2013/04/11
(TA)
|
--
|
SUN PHARMA GLOBAL |
None (Tentative Approval) |
| SITAGLIPTIN PHOSPHATE |
202423 |
003 |
ANDA |
SITAGLIPTIN PHOSPHATE |
TABLET; ORAL |
100MG |
No
|
No
|
2013/04/11
(TA)
|
--
|
SUN PHARMA GLOBAL |
None (Tentative Approval) |
| SITAGLIPTIN PHOSPHATE |
202425 |
001 |
ANDA |
SITAGLIPTIN PHOSPHATE |
TABLET; ORAL |
25MG |
No
|
No
|
2014/02/18
(TA)
|
--
|
APOTEX INC |
None (Tentative Approval) |
| SITAGLIPTIN PHOSPHATE |
202425 |
002 |
ANDA |
SITAGLIPTIN PHOSPHATE |
TABLET; ORAL |
50MG |
No
|
No
|
2014/02/18
(TA)
|
--
|
APOTEX INC |
None (Tentative Approval) |
| SITAGLIPTIN PHOSPHATE |
202425 |
003 |
ANDA |
SITAGLIPTIN PHOSPHATE |
TABLET; ORAL |
100MG |
No
|
No
|
2014/02/18
(TA)
|
--
|
APOTEX INC |
None (Tentative Approval) |
| SITAGLIPTIN PHOSPHATE |
202327 |
001 |
ANDA |
SITAGLIPTIN PHOSPHATE |
TABLET;ORAL |
25MG |
No
|
No
|
2014/04/15
(TA)
|
--
|
WATSON LABS INC |
None (Tentative Approval) |
| SITAGLIPTIN PHOSPHATE |
202327 |
002 |
ANDA |
SITAGLIPTIN PHOSPHATE |
TABLET;ORAL |
50MG |
No
|
No
|
2014/04/15
(TA)
|
--
|
WATSON LABS INC |
None (Tentative Approval) |
| SITAGLIPTIN PHOSPHATE |
202327 |
003 |
ANDA |
SITAGLIPTIN PHOSPHATE |
TABLET;ORAL |
100MG |
No
|
No
|
2014/04/15
(TA)
|
--
|
WATSON LABS INC |
None (Tentative Approval) |
| SITAGLIPTIN PHOSPHATE |
202487 |
001 |
ANDA |
SITAGLIPTIN PHOSPHATE |
TABLET;ORAL |
25MG |
No
|
No
|
2015/02/23
(TA)
|
--
|
TEVA PHARMS USA |
None (Tentative Approval) |
| SITAGLIPTIN PHOSPHATE |
202487 |
002 |
ANDA |
SITAGLIPTIN PHOSPHATE |
TABLET;ORAL |
50MG |
No
|
No
|
2015/02/23
(TA)
|
--
|
TEVA PHARMS USA |
None (Tentative Approval) |
| SITAGLIPTIN PHOSPHATE |
202487 |
003 |
ANDA |
SITAGLIPTIN PHOSPHATE |
TABLET;ORAL |
100MG |
No
|
No
|
2015/02/23
(TA)
|
--
|
TEVA PHARMS USA |
None (Tentative Approval) |
| SITAGLIPTIN PHOSPHATE; METFORMIN HYDROCHLORIDE |
204591 |
001 |
ANDA |
SITAGLIPTIN PHOSPHATE;METFORMIN HYDROCHLORIDE |
TABLET, EXTENDED RELEASE;ORAL |
50MG;500MG |
No
|
No
|
2015/09/29
(TA)
|
--
|
TEVA PHARMS USA INC |
None (Tentative Approval) |
| SITAGLIPTIN PHOSPHATE; METFORMIN HYDROCHLORIDE |
204591 |
002 |
ANDA |
SITAGLIPTIN PHOSPHATE;METFORMIN HYDROCHLORIDE |
TABLET, EXTENDED RELEASE;ORAL |
50MG;1000MG |
No
|
No
|
2015/09/29
(TA)
|
--
|
TEVA PHARMS USA INC |
None (Tentative Approval) |
| 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) |