LINAGLIPTIN |
208415 |
001 |
ANDA |
LINAGLIPTIN |
TABLET;ORAL |
5MG |
No
|
No
|
2017/06/16
(TA)
|
--
|
AUROBINDO PHARMA LTD |
None (Tentative Approval) |
LINAGLIPTIN; METFORMIN HYDROCHLORIDE |
208430 |
001 |
ANDA |
LINAGLIPTIN;METFORMIN HYDROCHLORIDE |
TABLET;ORAL |
2.5MG;500MG |
No
|
No
|
2018/11/01
(TA)
|
--
|
MYLAN PHARMS INC |
None (Tentative Approval) |
LINAGLIPTIN; METFORMIN HYDROCHLORIDE |
208430 |
002 |
ANDA |
LINAGLIPTIN;METFORMIN HYDROCHLORIDE |
TABLET;ORAL |
2.5MG;850MG |
No
|
No
|
2018/11/01
(TA)
|
--
|
MYLAN PHARMS INC |
None (Tentative Approval) |
LINAGLIPTIN; METFORMIN HYDROCHLORIDE |
208430 |
003 |
ANDA |
LINAGLIPTIN;METFORMIN HYDROCHLORIDE |
TABLET;ORAL |
2.5MG;1GM |
No
|
No
|
2018/11/01
(TA)
|
--
|
MYLAN PHARMS INC |
None (Tentative Approval) |
LINAGLIPTIN AND METFORMIN HYDROCHLORIDE |
208454 |
001 |
ANDA |
LINAGLIPTIN AND METFORMIN HYDROCHLORIDE |
TABLET; ORAL |
2.5MG/500MG |
No
|
No
|
2020/05/28
(TA)
|
--
|
SUN PHARM INDS LTD |
None (Tentative Approval) |
LINAGLIPTIN AND METFORMIN HYDROCHLORIDE |
208454 |
002 |
ANDA |
LINAGLIPTIN AND METFORMIN HYDROCHLORIDE |
TABLET; ORAL |
2.5MG/850MG |
No
|
No
|
2020/05/28
(TA)
|
--
|
SUN PHARM INDS LTD |
None (Tentative Approval) |
LINAGLIPTIN AND METFORMIN HYDROCHLORIDE |
208454 |
003 |
ANDA |
LINAGLIPTIN AND METFORMIN HYDROCHLORIDE |
TABLET; ORAL |
2.5MG/1GM |
No
|
No
|
2020/05/28
(TA)
|
--
|
SUN PHARM INDS LTD |
None (Tentative Approval) |
EMPAGLIFLOZIN AND LINAGLIPTIN |
212359 |
001 |
ANDA |
EMPAGLIFLOZIN; LINAGLIPTIN |
TABLET;ORAL |
10MG; 5MG |
No
|
No
|
2020/07/07
(TA)
|
--
|
MSN LABS PVT LTD |
None (Tentative Approval) |
EMPAGLIFLOZIN AND LINAGLIPTIN |
212359 |
002 |
ANDA |
EMPAGLIFLOZIN; LINAGLIPTIN |
TABLET;ORAL |
25MG; 5MG |
No
|
No
|
2020/07/07
(TA)
|
--
|
MSN LABS PVT LTD |
None (Tentative Approval) |
EMPAGLIFLOZIN; LINAGLIPTIN |
212354 |
001 |
ANDA |
EMPAGLIFLOZIN; LINAGLIPTIN |
TABLET; ORAL |
10MG/5MG |
No
|
No
|
2020/08/26
(TA)
|
--
|
KINAPSE LIMITED |
None (Tentative Approval) |
EMPAGLIFLOZIN; LINAGLIPTIN |
212354 |
002 |
ANDA |
EMPAGLIFLOZIN; LINAGLIPTIN |
TABLET;ORAL |
25MG/5MG |
No
|
No
|
2020/08/26
(TA)
|
--
|
KINAPSE LIMITED |
None (Tentative Approval) |
LINAGLIPTIN AND METFORMIN HYDROCHLORIDE |
208427 |
001 |
ANDA |
LINAGLIPTIN; METFORMIN HYDROCHLORIDE |
TABLET;ORAL |
2.5MG; 500MG |
No
|
No
|
2021/02/01
(TA)
|
--
|
DR REDDYS LABS LTD |
None (Tentative Approval) |
LINAGLIPTIN AND METFORMIN HYDROCHLORIDE |
208427 |
002 |
ANDA |
LINAGLIPTIN; METFORMIN HYDROCHLORIDE |
TABLET;ORAL |
2.5MG; 850MG |
No
|
No
|
2021/02/01
(TA)
|
--
|
DR REDDYS LABS LTD |
None (Tentative Approval) |
LINAGLIPTIN AND METFORMIN HYDROCHLORIDE |
208427 |
003 |
ANDA |
LINAGLIPTIN; METFORMIN HYDROCHLORIDE |
TABLET;ORAL |
2.5MG; 1G |
No
|
No
|
2021/02/01
(TA)
|
--
|
DR REDDYS LABS LTD |
None (Tentative Approval) |
LINAGLIPTIN |
208428 |
001 |
ANDA |
LINAGLIPTIN |
TABLET;ORAL |
5MG |
No
|
No
|
2021/02/25
(TA)
|
--
|
DR REDDYS LABS LTD |
None (Tentative Approval) |
EMPAGLIFLOZIN; LINAGLIPTIN |
212364 |
001 |
ANDA |
EMPAGLIFLOZIN;LINAGLIPTIN |
TABLET;ORAL |
10MG; 5MG |
No
|
No
|
2021/03/30
(TA)
|
--
|
ANNORA PHARMA |
None (Tentative Approval) |
EMPAGLIFLOZIN; LINAGLIPTIN |
212364 |
002 |
ANDA |
EMPAGLIFLOZIN;LINAGLIPTIN |
TABLET;ORAL |
25MG; 5MG |
No
|
No
|
2021/03/30
(TA)
|
--
|
ANNORA PHARMA |
None (Tentative Approval) |
LINAGLIPTIN AND METFORMIN HYDROCHLORIDE |
208336 |
001 |
ANDA |
LINAGLIPTIN; METFORMIN HYDROCHLORIDE |
TABLET;ORAL |
2.5MG;500MG |
No
|
No
|
2021/08/30
|
2021/08/30
|
SUNSHINE |
Prescription |
LINAGLIPTIN AND METFORMIN HYDROCHLORIDE |
208336 |
002 |
ANDA |
LINAGLIPTIN; METFORMIN HYDROCHLORIDE |
TABLET;ORAL |
2.5MG;850MG |
No
|
No
|
2021/08/30
|
2021/08/30
|
SUNSHINE |
Prescription |
LINAGLIPTIN AND METFORMIN HYDROCHLORIDE |
208336 |
003 |
ANDA |
LINAGLIPTIN; METFORMIN HYDROCHLORIDE |
TABLET;ORAL |
2.5MG;1GM |
No
|
No
|
2021/08/30
|
2021/08/30
|
SUNSHINE |
Prescription |