| EMPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE |
212198 |
003 |
ANDA |
EMPAGLIFLOZIN; METFORMIN HYDROCHLORIDE |
TABLET;ORAL |
12.5MG;500MG |
No
|
No
|
2022/07/07
|
2022/07/07
|
ZYDUS PHARMS |
Discontinued |
| EMPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE |
212198 |
004 |
ANDA |
EMPAGLIFLOZIN; METFORMIN HYDROCHLORIDE |
TABLET;ORAL |
12.5MG;1GM |
No
|
No
|
2022/07/07
|
2022/07/07
|
ZYDUS PHARMS |
Discontinued |
| DAPAGLIFLOZIN;METFORMIN HYDROCHLORIDE |
211583 |
001 |
ANDA |
DAPAGLIFLOZIN;METFORMIN HYDROCHLORIDE |
TABLET, EXTENDED RELEASE;ORAL |
2.5MG/1000MG |
No
|
No
|
2022/08/03
(TA)
|
--
|
TEVA PHARMS USA INC |
None (Tentative Approval) |
| DAPAGLIFLOZIN;METFORMIN HYDROCHLORIDE |
211583 |
002 |
ANDA |
DAPAGLIFLOZIN;METFORMIN HYDROCHLORIDE |
TABLET, EXTENDED RELEASE;ORAL |
5MG/500MG |
No
|
No
|
2022/08/03
(TA)
|
--
|
TEVA PHARMS USA INC |
None (Tentative Approval) |
| DAPAGLIFLOZIN;METFORMIN HYDROCHLORIDE |
211583 |
003 |
ANDA |
DAPAGLIFLOZIN;METFORMIN HYDROCHLORIDE |
TABLET, EXTENDED RELEASE;ORAL |
5MG/1000MG |
No
|
No
|
2022/08/03
(TA)
|
--
|
TEVA PHARMS USA INC |
None (Tentative Approval) |
| DAPAGLIFLOZIN;METFORMIN HYDROCHLORIDE |
211583 |
004 |
ANDA |
DAPAGLIFLOZIN;METFORMIN HYDROCHLORIDE |
TABLET, EXTENDED RELEASE;ORAL |
10MG/500MG |
No
|
No
|
2022/08/03
(TA)
|
--
|
TEVA PHARMS USA INC |
None (Tentative Approval) |
| DAPAGLIFLOZIN;METFORMIN HYDROCHLORIDE |
211583 |
005 |
ANDA |
DAPAGLIFLOZIN;METFORMIN HYDROCHLORIDE |
TABLET, EXTENDED RELEASE;ORAL |
10MG/1000MG |
No
|
No
|
2022/08/03
(TA)
|
--
|
TEVA PHARMS USA INC |
None (Tentative Approval) |
| METFORMIN HYDROCHLORIDE |
212677 |
001 |
ANDA |
METFORMIN HYDROCHLORIDE |
SOLUTION;ORAL |
500MG/5ML |
No
|
No
|
2022/08/19
|
2022/08/19
|
VISTAPHARM LLC |
Prescription |
| METFORMIN HYDROCHLORIDE |
212448 |
001 |
ANDA |
METFORMIN HYDROCHLORIDE |
TABLET, EXTENDED RELEASE;ORAL |
500MG |
No
|
No
|
2023/01/10
|
2023/01/10
|
MICRO LABS |
Prescription |
| METFORMIN HYDROCHLORIDE |
212448 |
002 |
ANDA |
METFORMIN HYDROCHLORIDE |
TABLET, EXTENDED RELEASE;ORAL |
1GM |
No
|
No
|
2023/01/10
|
2023/01/10
|
MICRO LABS |
Prescription |
| EMPAGLIFLOZIN METFORMIN HYDROCHLORIDE |
212362 |
001 |
ANDA |
EMPAGLIFLOZIN;METFORMIN HYDROCHLORIDE |
TABLET, EXTENDED RELEASE; ORAL |
5MG/1000MG |
No
|
No
|
2023/01/31
(TA)
|
--
|
MSN LABS PVT LTD |
None (Tentative Approval) |
| EMPAGLIFLOZIN METFORMIN HYDROCHLORIDE |
212362 |
002 |
ANDA |
EMPAGLIFLOZIN;METFORMIN HYDROCHLORIDE |
TABLET, EXTENDED RELEASE; ORAL |
10MG/1000MG |
No
|
No
|
2023/01/31
(TA)
|
--
|
MSN LABS PVT LTD |
None (Tentative Approval) |
| 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 |
Prescription |
| 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 |
Prescription |