METFORMIN HYDROCHLORIDE |
214629 |
002 |
ANDA |
METFORMIN HYDROCHLORIDE |
TABLET, EXTENDED RELEASE;ORAL |
1GM |
No
|
No
|
2022/02/22
|
2022/02/22
|
SCIEGEN PHARMS INC |
Prescription |
LINAGLIPTIN AND METFORMIN HYDROCHLORIDE |
208473 |
002 |
ANDA |
LINAGLIPTIN; METFORMIN HYDROCHLORIDE |
TABLET;ORAL |
2.5MG;850MG |
No
|
No
|
2022/04/05
(TA)
|
--
|
PRINSTON PHARMA INC |
None (Tentative Approval) |
LINAGLIPTIN AND METFORMIN HYDROCHLORIDE |
208473 |
003 |
ANDA |
LINAGLIPTIN; METFORMIN HYDROCHLORIDE |
TABLET;ORAL |
2.5MG;1GM |
No
|
No
|
2022/04/05
(TA)
|
--
|
PRINSTON PHARMA INC |
None (Tentative Approval) |
SITAGLIPTIN AND METFORMIN HYDROCHLORIDE |
215220 |
002 |
ANDA |
SITAGLIPTIN; METFORMIN HYDROCHLORIDE |
TABLET; ORAL |
50MG/1000MG |
No
|
No
|
2022/05/31
(TA)
|
--
|
AJANTA PHARMA LTD |
None (Tentative Approval) |
METFORMIN HYDROCHLORIDE |
212681 |
001 |
ANDA |
METFORMIN HYDROCHLORIDE |
TABLET, EXTENDED RELEASE;ORAL |
500MG |
No
|
No
|
2022/06/09
|
2022/06/09
|
PRINSTON INC |
Prescription |
METFORMIN HYDROCHLORIDE |
212681 |
002 |
ANDA |
METFORMIN HYDROCHLORIDE |
TABLET, EXTENDED RELEASE;ORAL |
1GM |
No
|
No
|
2022/06/09
|
2022/06/09
|
PRINSTON INC |
Prescription |
EMPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE |
212198 |
001 |
ANDA |
EMPAGLIFLOZIN; METFORMIN HYDROCHLORIDE |
TABLET;ORAL |
5MG;500MG |
No
|
No
|
2022/07/07
|
2022/07/07
|
ZYDUS PHARMS |
Discontinued |
EMPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE |
212198 |
002 |
ANDA |
EMPAGLIFLOZIN; METFORMIN HYDROCHLORIDE |
TABLET;ORAL |
5MG;1GM |
No
|
No
|
2022/07/07
|
2022/07/07
|
ZYDUS PHARMS |
Discontinued |
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 |
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) |