| METFORMIN HYDROCHLORIDE |
202306 |
001 |
ANDA |
METFORMIN HYDROCHLORIDE |
TABLET, EXTENDED RELEASE;ORAL |
500MG |
No
|
No
|
2017/02/23
|
2017/02/23
|
MEDICAP LABS |
Prescription |
| METFORMIN HYDROCHLORIDE |
202306 |
002 |
ANDA |
METFORMIN HYDROCHLORIDE |
TABLET, EXTENDED RELEASE;ORAL |
750MG |
No
|
No
|
2017/02/23
|
2017/02/23
|
MEDICAP LABS |
Prescription |
| ROSIGLITAZONE MALEATE AND METFORMIN HYDROCHLORIDE |
077337 |
001 |
ANDA |
METFORMIN HYDROCHLORIDE; ROSIGLITAZONE MALEATE |
TABLET;ORAL |
500MG;EQ 2MG BASE |
No
|
No
|
2017/05/19
|
2014/05/07
|
TEVA |
Discontinued |
| ROSIGLITAZONE MALEATE AND METFORMIN HYDROCHLORIDE |
077337 |
002 |
ANDA |
METFORMIN HYDROCHLORIDE; ROSIGLITAZONE MALEATE |
TABLET;ORAL |
500MG;EQ 4MG BASE |
No
|
No
|
2017/05/19
|
2014/05/07
|
TEVA |
Discontinued |
| ROSIGLITAZONE MALEATE AND METFORMIN HYDROCHLORIDE |
077337 |
003 |
ANDA |
METFORMIN HYDROCHLORIDE; ROSIGLITAZONE MALEATE |
TABLET;ORAL |
1GM;EQ 2MG BASE |
No
|
No
|
2017/05/19
|
2014/05/07
|
TEVA |
Discontinued |
| ROSIGLITAZONE MALEATE AND METFORMIN HYDROCHLORIDE |
077337 |
004 |
ANDA |
METFORMIN HYDROCHLORIDE; ROSIGLITAZONE MALEATE |
TABLET;ORAL |
1GM;EQ 4MG BASE |
No
|
No
|
2017/05/19
|
2014/05/07
|
TEVA |
Discontinued |
| ROSIGLITAZONE MALEATE AND METFORMIN HYDROCHLORIDE |
077337 |
005 |
ANDA |
METFORMIN HYDROCHLORIDE; ROSIGLITAZONE MALEATE |
TABLET;ORAL |
500MG;EQ 1MG BASE |
No
|
No
|
2017/05/19
|
2017/05/19
|
TEVA |
Discontinued |
| METFORMIN HYDROCHLORIDE AND SITAGLIPTIN PHOSPHATE |
208535 |
001 |
ANDA |
METFORMIN HYDROCHLORIDE;SITAGLIPTIN PHOSPHATE |
TABLET;ORAL |
50MG/500MG;50MG/1000MG |
No
|
No
|
2017/07/03
(TA)
|
--
|
ZYDUS PHARMS USA INC |
None (Tentative Approval) |
| METFORMIN HYDROCHLORIDE |
205330 |
001 |
ANDA |
METFORMIN HYDROCHLORIDE |
TABLET;ORAL |
500MG |
No
|
No
|
2017/10/31
|
2017/10/31
|
AARXION ANDA HLDING |
Discontinued |
| METFORMIN HYDROCHLORIDE |
205330 |
002 |
ANDA |
METFORMIN HYDROCHLORIDE |
TABLET;ORAL |
850MG |
No
|
No
|
2017/10/31
|
2017/10/31
|
AARXION ANDA HLDING |
Discontinued |
| METFORMIN HYDROCHLORIDE |
205330 |
003 |
ANDA |
METFORMIN HYDROCHLORIDE |
TABLET;ORAL |
1GM |
No
|
No
|
2017/10/31
|
2017/10/31
|
AARXION ANDA HLDING |
Discontinued |
| METFORMIN HYDROCHLORIDE |
203832 |
001 |
ANDA |
METFORMIN HYDROCHLORIDE |
TABLET, EXTENDED RELEASE;ORAL |
500MG |
No
|
No
|
2017/12/26
|
2017/12/26
|
MPP PHARMA |
Prescription |
| METFORMIN HYDROCHLORIDE |
203832 |
002 |
ANDA |
METFORMIN HYDROCHLORIDE |
TABLET, EXTENDED RELEASE;ORAL |
1GM |
No
|
No
|
2017/12/26
|
2017/12/26
|
MPP PHARMA |
Prescription |
| METFORMIN HYDROCHLORIDE |
209313 |
001 |
ANDA |
METFORMIN HYDROCHLORIDE |
TABLET, EXTENDED RELEASE;ORAL |
500MG |
No
|
No
|
2018/03/16
|
2018/03/16
|
GRANULES |
Prescription |
| METFORMIN HYDROCHLORIDE |
209313 |
002 |
ANDA |
METFORMIN HYDROCHLORIDE |
TABLET, EXTENDED RELEASE;ORAL |
750MG |
No
|
No
|
2018/03/16
|
2018/03/16
|
GRANULES |
Prescription |
| METFORMIN HYDROCHLORIDE |
209303 |
001 |
ANDA |
METFORMIN HYDROCHLORIDE |
TABLET, EXTENDED RELEASE;ORAL |
500MG |
No
|
No
|
2018/03/19
|
2018/03/19
|
ALIGNSCIENCE PHARMA |
Prescription |
| METFORMIN HYDROCHLORIDE |
209882 |
001 |
ANDA |
METFORMIN HYDROCHLORIDE |
TABLET;ORAL |
500MG |
No
|
No
|
2018/08/27
|
2018/08/27
|
LAURUS |
Prescription |
| METFORMIN HYDROCHLORIDE |
209882 |
002 |
ANDA |
METFORMIN HYDROCHLORIDE |
TABLET;ORAL |
850MG |
No
|
No
|
2018/08/27
|
2018/08/27
|
LAURUS |
Prescription |
| METFORMIN HYDROCHLORIDE |
209882 |
003 |
ANDA |
METFORMIN HYDROCHLORIDE |
TABLET;ORAL |
1GM |
No
|
No
|
2018/08/27
|
2018/08/27
|
LAURUS |
Prescription |
| METFORMIN HYDROCHLORIDE |
208880 |
001 |
ANDA |
METFORMIN HYDROCHLORIDE |
TABLET, EXTENDED RELEASE;ORAL |
500MG |
No
|
No
|
2018/09/10
|
2018/09/10
|
PRINSTON INC |
Prescription |