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) |
PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE |
204802 |
001 |
ANDA |
METFORMIN HYDROCHLORIDE; PIOGLITAZONE HYDROCHLORIDE |
TABLET;ORAL |
500MG;EQ 15MG BASE |
No
|
No
|
2015/11/05
|
2015/11/05
|
MACLEODS PHARMS LTD |
Prescription |
PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE |
204802 |
002 |
ANDA |
METFORMIN HYDROCHLORIDE; PIOGLITAZONE HYDROCHLORIDE |
TABLET;ORAL |
850MG;EQ 15MG BASE |
No
|
No
|
2015/11/05
|
2015/11/05
|
MACLEODS PHARMS LTD |
Prescription |
SAXAGLIPTIN;METFORMIN HYDROCHLORIDE |
205942 |
001 |
ANDA |
SAXAGLIPTIN;METFORMIN HYDROCHLORIDE |
TABLET, EXTENDED RELEASE;ORAL |
5MG;500MG |
No
|
No
|
2016/01/21
(TA)
|
--
|
AMNEAL PHARMS |
None (Tentative Approval) |
SAXAGLIPTIN;METFORMIN HYDROCHLORIDE |
205942 |
002 |
ANDA |
SAXAGLIPTIN;METFORMIN HYDROCHLORIDE |
TABLET, EXTENDED RELEASE;ORAL |
2.5MG;1000MG |
No
|
No
|
2016/01/21
(TA)
|
--
|
AMNEAL PHARMS |
None (Tentative Approval) |
SAXAGLIPTIN;METFORMIN HYDROCHLORIDE |
205942 |
003 |
ANDA |
SAXAGLIPTIN;METFORMIN HYDROCHLORIDE |
TABLET, EXTENDED RELEASE;ORAL |
5MG;1000MG |
No
|
No
|
2016/01/21
(TA)
|
--
|
AMNEAL PHARMS |
None (Tentative Approval) |
GLYBURIDE AND METFORMIN HYDROCHLORIDE |
206748 |
001 |
ANDA |
GLYBURIDE; METFORMIN HYDROCHLORIDE |
TABLET;ORAL |
1.25MG;250MG |
No
|
No
|
2016/02/29
|
2016/02/29
|
ZYDUS PHARMS |
Prescription |
GLYBURIDE AND METFORMIN HYDROCHLORIDE |
206748 |
002 |
ANDA |
GLYBURIDE; METFORMIN HYDROCHLORIDE |
TABLET;ORAL |
2.5MG;500MG |
No
|
No
|
2016/02/29
|
2016/02/29
|
ZYDUS PHARMS |
Prescription |
GLYBURIDE AND METFORMIN HYDROCHLORIDE |
206748 |
003 |
ANDA |
GLYBURIDE; METFORMIN HYDROCHLORIDE |
TABLET;ORAL |
5MG;500MG |
No
|
No
|
2016/02/29
|
2016/02/29
|
ZYDUS PHARMS |
Prescription |
METFORMIN HYDROCHLORIDE |
090295 |
001 |
ANDA |
METFORMIN HYDROCHLORIDE |
TABLET, EXTENDED RELEASE;ORAL |
500MG |
No
|
No
|
2016/04/29
|
2016/04/29
|
MARKSANS PHARMA |
Prescription |
METFORMIN HYDROCHLORIDE |
090295 |
002 |
ANDA |
METFORMIN HYDROCHLORIDE |
TABLET, EXTENDED RELEASE;ORAL |
750MG |
No
|
No
|
2016/04/29
|
2016/04/29
|
MARKSANS PHARMA |
Prescription |
METFORMIN HYDROCHLORIDE |
205096 |
001 |
ANDA |
METFORMIN HYDROCHLORIDE |
TABLET;ORAL |
500MG |
No
|
No
|
2016/07/11
|
2016/07/11
|
CSPC OUYI |
Prescription |
METFORMIN HYDROCHLORIDE |
205096 |
002 |
ANDA |
METFORMIN HYDROCHLORIDE |
TABLET;ORAL |
850MG |
No
|
No
|
2016/07/11
|
2016/07/11
|
CSPC OUYI |
Prescription |
METFORMIN HYDROCHLORIDE |
205096 |
003 |
ANDA |
METFORMIN HYDROCHLORIDE |
TABLET;ORAL |
1GM |
No
|
No
|
2016/07/11
|
2016/07/11
|
CSPC OUYI |
Prescription |
METFORMIN HYDROCHLORIDE |
202917 |
001 |
ANDA |
METFORMIN HYDROCHLORIDE |
TABLET, EXTENDED RELEASE;ORAL |
500MG |
No
|
No
|
2016/08/01
|
2016/08/01
|
SUN PHARM |
Prescription |
METFORMIN HYDROCHLORIDE |
202917 |
002 |
ANDA |
METFORMIN HYDROCHLORIDE |
TABLET, EXTENDED RELEASE;ORAL |
1GM |
No
|
No
|
2016/08/01
|
2016/08/01
|
SUN PHARM |
Prescription |
METFORMIN HYDROCHLORIDE |
203755 |
001 |
ANDA |
METFORMIN HYDROCHLORIDE |
TABLET, EXTENDED RELEASE;ORAL |
500MG |
No
|
No
|
2016/08/01
|
2016/08/01
|
ACTAVIS LABS FL INC |
Prescription |