| METFORMIN HYDROCHLORIDE |
213359 |
002 |
ANDA |
METFORMIN HYDROCHLORIDE |
TABLET, EXTENDED RELEASE;ORAL |
750MG |
No
|
No
|
2021/08/11
|
2021/08/11
|
UNICHEM |
Prescription |
| 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 |
| METFORMIN HYDROCHLORIDE |
213247 |
001 |
ANDA |
METFORMIN HYDROCHLORIDE |
TABLET, EXTENDED RELEASE;ORAL |
500MG |
No
|
No
|
2021/09/29
|
2021/09/29
|
TWI PHARMS |
Discontinued |
| METFORMIN HYDROCHLORIDE |
213247 |
002 |
ANDA |
METFORMIN HYDROCHLORIDE |
TABLET, EXTENDED RELEASE;ORAL |
1GM |
No
|
No
|
2021/09/29
|
2021/09/29
|
TWI PHARMS |
Discontinued |
| METFORMIN HYDROCHLORIDE |
213320 |
001 |
ANDA |
METFORMIN HYDROCHLORIDE |
TABLET;ORAL |
500MG |
No
|
No
|
2021/12/03
|
2021/12/03
|
HARMAN FINOCHEM |
Prescription |
| METFORMIN HYDROCHLORIDE |
213320 |
002 |
ANDA |
METFORMIN HYDROCHLORIDE |
TABLET;ORAL |
850MG |
No
|
No
|
2021/12/03
|
2021/12/03
|
HARMAN FINOCHEM |
Prescription |
| METFORMIN HYDROCHLORIDE |
213320 |
003 |
ANDA |
METFORMIN HYDROCHLORIDE |
TABLET;ORAL |
1GM |
No
|
No
|
2021/12/03
|
2021/12/03
|
HARMAN FINOCHEM |
Prescription |
| METFORMIN HYDROCHLORIDE |
213356 |
001 |
ANDA |
METFORMIN HYDROCHLORIDE |
TABLET, EXTENDED RELEASE;ORAL |
500MG |
No
|
No
|
2021/12/13
|
2021/12/13
|
APOTEX |
Prescription |
| METFORMIN HYDROCHLORIDE |
213356 |
002 |
ANDA |
METFORMIN HYDROCHLORIDE |
TABLET, EXTENDED RELEASE;ORAL |
1GM |
No
|
No
|
2021/12/13
|
2021/12/13
|
APOTEX |
Prescription |
| METFORMIN HYDROCHLORIDE |
214629 |
001 |
ANDA |
METFORMIN HYDROCHLORIDE |
TABLET, EXTENDED RELEASE;ORAL |
500MG |
No
|
No
|
2022/02/22
|
2022/02/22
|
SCIEGEN PHARMS INC |
Prescription |
| 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 |