EMPAGLIFLOZIN METFORMIN HYDROCHLORIDE |
212362 |
003 |
ANDA |
EMPAGLIFLOZIN;METFORMIN HYDROCHLORIDE |
TABLET, EXTENDED RELEASE; ORAL |
12.5MG/1000MG |
No
|
No
|
2023/01/31
(TA)
|
--
|
MSN LABS PVT LTD |
None (Tentative Approval) |
EMPAGLIFLOZIN METFORMIN HYDROCHLORIDE |
212362 |
004 |
ANDA |
EMPAGLIFLOZIN;METFORMIN HYDROCHLORIDE |
TABLET, EXTENDED RELEASE; ORAL |
25MG/1000MG |
No
|
No
|
2023/01/31
(TA)
|
--
|
MSN LABS PVT LTD |
None (Tentative Approval) |
CANAGLIFLOZIN; METFORMIN HYDROCHLORIDE |
210542 |
001 |
ANDA |
CANAGLIFLOZIN;METFORMIN HYDROCHLORIDE |
TABLET;ORAL |
50MG;500MG |
No
|
No
|
2023/02/16
(TA)
|
--
|
ZYDUS PHARMS USA INC |
None (Tentative Approval) |
CANAGLIFLOZIN; METFORMIN HYDROCHLORIDE |
210542 |
002 |
ANDA |
CANAGLIFLOZIN;METFORMIN HYDROCHLORIDE |
TABLET;ORAL |
50MG;1000MG |
No
|
No
|
2023/02/16
(TA)
|
--
|
ZYDUS PHARMS USA INC |
None (Tentative Approval) |
CANAGLIFLOZIN; METFORMIN HYDROCHLORIDE |
210542 |
003 |
ANDA |
CANAGLIFLOZIN;METFORMIN HYDROCHLORIDE |
TABLET;ORAL |
150MG;500MG |
No
|
No
|
2023/02/16
(TA)
|
--
|
ZYDUS PHARMS USA INC |
None (Tentative Approval) |
CANAGLIFLOZIN; METFORMIN HYDROCHLORIDE |
210542 |
004 |
ANDA |
CANAGLIFLOZIN;METFORMIN HYDROCHLORIDE |
TABLET;ORAL |
150MG;1000MG |
No
|
No
|
2023/02/16
(TA)
|
--
|
ZYDUS PHARMS USA INC |
None (Tentative Approval) |
LINAGLIPTIN AND METFORMIN HYDROCHLORIDE |
208449 |
001 |
ANDA |
LINAGLIPTIN; METFORMIN HYDROCHLORIDE |
TABLET;ORAL |
2.5MG;500MG |
No
|
No
|
2023/03/30
|
2023/03/30
|
ZYDUS PHARMS |
Discontinued |
LINAGLIPTIN AND METFORMIN HYDROCHLORIDE |
208449 |
002 |
ANDA |
LINAGLIPTIN; METFORMIN HYDROCHLORIDE |
TABLET;ORAL |
2.5MG;850MG |
No
|
No
|
2023/03/30
|
2023/03/30
|
ZYDUS PHARMS |
Discontinued |
LINAGLIPTIN AND METFORMIN HYDROCHLORIDE |
208449 |
003 |
ANDA |
LINAGLIPTIN; METFORMIN HYDROCHLORIDE |
TABLET;ORAL |
2.5MG;1GM |
No
|
No
|
2023/03/30
|
2023/03/30
|
ZYDUS PHARMS |
Discontinued |
METFORMIN HYDROCHLORIDE |
215629 |
001 |
ANDA |
METFORMIN HYDROCHLORIDE |
TABLET, EXTENDED RELEASE;ORAL |
500MG |
No
|
No
|
2023/06/20
|
2023/06/20
|
RK PHARMA |
Prescription |
METFORMIN HYDROCHLORIDE |
215629 |
002 |
ANDA |
METFORMIN HYDROCHLORIDE |
TABLET, EXTENDED RELEASE;ORAL |
1GM |
No
|
No
|
2023/06/20
|
2023/06/20
|
RK PHARMA |
Prescription |
SAXAGLIPTIN AND METFORMIN HYDROCHLORIDE |
205981 |
001 |
ANDA |
METFORMIN HYDROCHLORIDE; SAXAGLIPTIN HYDROCHLORIDE |
TABLET, EXTENDED RELEASE;ORAL |
500MG;EQ 5MG BASE |
No
|
No
|
2023/07/31
|
2023/07/31
|
MYLAN |
Prescription |
SAXAGLIPTIN AND METFORMIN HYDROCHLORIDE |
205981 |
002 |
ANDA |
METFORMIN HYDROCHLORIDE; SAXAGLIPTIN HYDROCHLORIDE |
TABLET, EXTENDED RELEASE;ORAL |
1GM;EQ 2.5MG BASE |
No
|
No
|
2023/07/31
|
2023/07/31
|
MYLAN |
Prescription |
SAXAGLIPTIN AND METFORMIN HYDROCHLORIDE |
205981 |
003 |
ANDA |
METFORMIN HYDROCHLORIDE; SAXAGLIPTIN HYDROCHLORIDE |
TABLET, EXTENDED RELEASE;ORAL |
1GM;EQ 5MG BASE |
No
|
No
|
2023/07/31
|
2023/07/31
|
MYLAN |
Prescription |
SAXAGLIPTIN AND METFORMIN HYDROCHLORIDE |
206081 |
001 |
ANDA |
METFORMIN HYDROCHLORIDE; SAXAGLIPTIN HYDROCHLORIDE |
TABLET, EXTENDED RELEASE;ORAL |
500MG;EQ 5MG BASE |
No
|
No
|
2023/07/31
|
2023/07/31
|
SUN PHARM |
Prescription |
SAXAGLIPTIN AND METFORMIN HYDROCHLORIDE |
206081 |
002 |
ANDA |
METFORMIN HYDROCHLORIDE; SAXAGLIPTIN HYDROCHLORIDE |
TABLET, EXTENDED RELEASE;ORAL |
1GM;EQ 2.5MG BASE |
No
|
No
|
2023/07/31
|
2023/07/31
|
SUN PHARM |
Prescription |
SAXAGLIPTIN AND METFORMIN HYDROCHLORIDE |
206081 |
003 |
ANDA |
METFORMIN HYDROCHLORIDE; SAXAGLIPTIN HYDROCHLORIDE |
TABLET, EXTENDED RELEASE;ORAL |
1GM;EQ 5MG BASE |
No
|
No
|
2023/07/31
|
2023/07/31
|
SUN PHARM |
Prescription |
METFORMIN HYDROCHLORIDE; SAXAGLIPTIN HYDROCHLORIDE |
207678 |
001 |
ANDA |
METFORMIN HYDROCHLORIDE; SAXAGLIPTIN HYDROCHLORIDE |
TABLET, EXTENDED RELEASE;ORAL |
500MG;EQ 5MG BASE |
No
|
No
|
2023/08/09
|
2023/08/09
|
DR REDDYS LABS SA |
Prescription |
METFORMIN HYDROCHLORIDE; SAXAGLIPTIN HYDROCHLORIDE |
207678 |
002 |
ANDA |
METFORMIN HYDROCHLORIDE; SAXAGLIPTIN HYDROCHLORIDE |
TABLET, EXTENDED RELEASE;ORAL |
1GM;EQ 2.5MG BASE |
No
|
No
|
2023/08/09
|
2023/08/09
|
DR REDDYS LABS SA |
Prescription |
METFORMIN HYDROCHLORIDE; SAXAGLIPTIN HYDROCHLORIDE |
207678 |
003 |
ANDA |
METFORMIN HYDROCHLORIDE; SAXAGLIPTIN HYDROCHLORIDE |
TABLET, EXTENDED RELEASE;ORAL |
1GM;EQ 5MG BASE |
No
|
Yes
|
2023/08/09
|
2023/08/09
|
DR REDDYS LABS SA |
Prescription |