| ALOGLIPTIN AND METFORMIN HYDROCHLORIDE |
210212 |
002 |
ANDA |
ALOGLIPTIN AND METFORMIN HYDROCHLORIDE |
TABLET; ORAL |
12.5MG/1000MG |
No
|
No
|
2019/11/27
(TA)
|
--
|
MSN LABORATORIES PRIVATE LTD |
None (Tentative Approval) |
| METFORMIN HYDROCHLORIDE |
211309 |
001 |
ANDA |
METFORMIN HYDROCHLORIDE |
SOLUTION;ORAL |
500MG/5ML |
No
|
Yes
|
2020/03/03
|
2020/03/03
|
SAPTALIS PHARMS |
Prescription |
| METFORMIN HYDROCHLORIDE |
213651 |
001 |
ANDA |
METFORMIN HYDROCHLORIDE |
TABLET, EXTENDED RELEASE;ORAL |
500MG |
No
|
No
|
2020/04/09
|
2020/04/09
|
AJANTA PHARMA LTD |
Prescription |
| METFORMIN HYDROCHLORIDE |
213651 |
002 |
ANDA |
METFORMIN HYDROCHLORIDE |
TABLET, EXTENDED RELEASE;ORAL |
1GM |
No
|
No
|
2020/04/09
|
2020/04/09
|
AJANTA PHARMA LTD |
Prescription |
| 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;METFORMIN HYDROCHLORIDE |
213654 |
001 |
ANDA |
EMPAGLIFLOZIN;METFORMIN HYDROCHLORIDE |
TABLET, EXTENDED RELEASE;ORAL |
5MG; 1GM |
No
|
No
|
2021/01/06
(TA)
|
--
|
LUPIN LTD |
None (Tentative Approval) |
| EMPAGLIFLOZIN;METFORMIN HYDROCHLORIDE |
213654 |
002 |
ANDA |
EMPAGLIFLOZIN;METFORMIN HYDROCHLORIDE |
TABLET, EXTENDED RELEASE;ORAL |
10MG; 1GM |
No
|
No
|
2021/01/06
(TA)
|
--
|
LUPIN LTD |
None (Tentative Approval) |
| EMPAGLIFLOZIN;METFORMIN HYDROCHLORIDE |
213654 |
003 |
ANDA |
EMPAGLIFLOZIN;METFORMIN HYDROCHLORIDE |
TABLET, EXTENDED RELEASE;ORAL |
12.5MG; 1GM |
No
|
No
|
2021/01/06
(TA)
|
--
|
LUPIN LTD |
None (Tentative Approval) |
| EMPAGLIFLOZIN;METFORMIN HYDROCHLORIDE |
213654 |
004 |
ANDA |
EMPAGLIFLOZIN;METFORMIN HYDROCHLORIDE |
TABLET, EXTENDED RELEASE;ORAL |
25MG; 1GM |
No
|
No
|
2021/01/06
(TA)
|
--
|
LUPIN LTD |
None (Tentative Approval) |
| METFORMIN HYDROCHLORIDE |
213344 |
001 |
ANDA |
METFORMIN HYDROCHLORIDE |
TABLET, EXTENDED RELEASE;ORAL |
500MG |
No
|
No
|
2021/01/14
|
2021/01/12
|
GRANULES |
Prescription |
| METFORMIN HYDROCHLORIDE |
213344 |
002 |
ANDA |
METFORMIN HYDROCHLORIDE |
TABLET, EXTENDED RELEASE;ORAL |
1GM |
No
|
No
|
2021/01/14
|
2021/01/12
|
GRANULES |
Prescription |
| METFORMIN HYDROCHLORIDE |
213962 |
001 |
ANDA |
METFORMIN HYDROCHLORIDE |
TABLET, EXTENDED RELEASE;ORAL |
500MG |
No
|
No
|
2021/03/09
|
2021/03/09
|
AJANTA PHARMA LTD |
Prescription |
| METFORMIN HYDROCHLORIDE |
213962 |
002 |
ANDA |
METFORMIN HYDROCHLORIDE |
TABLET, EXTENDED RELEASE;ORAL |
1GM |
No
|
No
|
2021/03/09
|
2021/03/09
|
AJANTA PHARMA LTD |
Prescription |
| METFORMIN HYDROCHLORIDE |
213334 |
001 |
ANDA |
METFORMIN HYDROCHLORIDE |
TABLET, EXTENDED RELEASE;ORAL |
500MG |
No
|
No
|
2021/04/16
|
2021/04/16
|
SCIEGEN PHARMS INC |
Prescription |
| METFORMIN HYDROCHLORIDE |
213334 |
002 |
ANDA |
METFORMIN HYDROCHLORIDE |
TABLET, EXTENDED RELEASE;ORAL |
1GM |
No
|
No
|
2021/04/16
|
2021/04/16
|
SCIEGEN PHARMS INC |
Prescription |
| METFORMIN HYDROCHLORIDE |
213394 |
001 |
ANDA |
METFORMIN HYDROCHLORIDE |
TABLET, EXTENDED RELEASE;ORAL |
500MG |
No
|
No
|
2021/08/03
|
2021/08/03
|
UTOPIC PHARMS |
Discontinued |
| METFORMIN HYDROCHLORIDE |
213394 |
002 |
ANDA |
METFORMIN HYDROCHLORIDE |
TABLET, EXTENDED RELEASE;ORAL |
1GM |
No
|
No
|
2021/08/03
|
2021/08/03
|
UTOPIC PHARMS |
Discontinued |
| METFORMIN HYDROCHLORIDE |
213359 |
001 |
ANDA |
METFORMIN HYDROCHLORIDE |
TABLET, EXTENDED RELEASE;ORAL |
500MG |
No
|
No
|
2021/08/11
|
2021/08/11
|
UNICHEM |
Prescription |