| METFORMIN HYDROCHLORIDE |
208880 |
002 |
ANDA |
METFORMIN HYDROCHLORIDE |
TABLET, EXTENDED RELEASE;ORAL |
750MG |
No
|
No
|
2018/09/10
|
2018/09/10
|
PRINSTON INC |
Prescription |
| METFORMIN HYDROCHLORIDE |
211052 |
001 |
ANDA |
METFORMIN HYDROCHLORIDE |
TABLET, EXTENDED RELEASE;ORAL |
500MG |
No
|
No
|
2018/09/24
|
2018/09/24
|
YICHANG HUMANWELL |
Prescription |
| METFORMIN HYDROCHLORIDE |
211052 |
002 |
ANDA |
METFORMIN HYDROCHLORIDE |
TABLET, EXTENDED RELEASE;ORAL |
750MG |
No
|
No
|
2018/09/24
|
2018/09/24
|
YICHANG HUMANWELL |
Prescription |
| METFORMIN HYDROCHLORIDE |
208999 |
001 |
ANDA |
METFORMIN HYDROCHLORIDE |
TABLET;ORAL |
500MG |
No
|
No
|
2018/10/12
|
2018/10/12
|
SUNSHINE |
Discontinued |
| METFORMIN HYDROCHLORIDE |
208999 |
002 |
ANDA |
METFORMIN HYDROCHLORIDE |
TABLET;ORAL |
850MG |
No
|
No
|
2018/10/12
|
2018/10/12
|
SUNSHINE |
Discontinued |
| METFORMIN HYDROCHLORIDE |
208999 |
003 |
ANDA |
METFORMIN HYDROCHLORIDE |
TABLET;ORAL |
1GM |
No
|
No
|
2018/10/12
|
2018/10/12
|
SUNSHINE |
Discontinued |
| METFORMIN HYDROCHLORIDE |
206145 |
001 |
ANDA |
METFORMIN HYDROCHLORIDE |
TABLET, EXTENDED RELEASE;ORAL |
500MG |
No
|
No
|
2018/10/22
|
2018/10/22
|
ALKEM LABS LTD |
Prescription |
| METFORMIN HYDROCHLORIDE |
206145 |
002 |
ANDA |
METFORMIN HYDROCHLORIDE |
TABLET, EXTENDED RELEASE;ORAL |
750MG |
No
|
Yes
|
2018/10/22
|
2018/10/22
|
ALKEM LABS LTD |
Prescription |
| LINAGLIPTIN; METFORMIN HYDROCHLORIDE |
208430 |
001 |
ANDA |
LINAGLIPTIN;METFORMIN HYDROCHLORIDE |
TABLET;ORAL |
2.5MG;500MG |
No
|
No
|
2018/11/01
(TA)
|
--
|
MYLAN PHARMS INC |
None (Tentative Approval) |
| LINAGLIPTIN; METFORMIN HYDROCHLORIDE |
208430 |
002 |
ANDA |
LINAGLIPTIN;METFORMIN HYDROCHLORIDE |
TABLET;ORAL |
2.5MG;850MG |
No
|
No
|
2018/11/01
(TA)
|
--
|
MYLAN PHARMS INC |
None (Tentative Approval) |
| LINAGLIPTIN; METFORMIN HYDROCHLORIDE |
208430 |
003 |
ANDA |
LINAGLIPTIN;METFORMIN HYDROCHLORIDE |
TABLET;ORAL |
2.5MG;1GM |
No
|
No
|
2018/11/01
(TA)
|
--
|
MYLAN PHARMS INC |
None (Tentative Approval) |
| METFORMIN HYDROCHLORIDE |
209674 |
001 |
ANDA |
METFORMIN HYDROCHLORIDE |
TABLET, EXTENDED RELEASE;ORAL |
500MG |
No
|
No
|
2018/11/02
|
2018/11/02
|
NOVAST LABS |
Prescription |
| METFORMIN HYDROCHLORIDE |
209674 |
002 |
ANDA |
METFORMIN HYDROCHLORIDE |
TABLET, EXTENDED RELEASE;ORAL |
1GM |
No
|
No
|
2018/11/02
|
2018/11/02
|
NOVAST LABS |
Prescription |
| ALOGLIPTIN; METFORMIN HYDROCHLORIDE |
210160 |
001 |
ANDA |
ALOGLIPTIN; METFORMIN HYDROCHLORIDE |
TABLET;ORAL |
EQ 12.5MG BASE;500MG |
No
|
No
|
2018/12/19
(TA)
|
--
|
TORRENT PHARMS LTD |
None (Tentative Approval) |
| ALOGLIPTIN; METFORMIN HYDROCHLORIDE |
210160 |
002 |
ANDA |
ALOGLIPTIN; METFORMIN HYDROCHLORIDE |
TABLET;ORAL |
EQ 12.5MG BASE;1GM |
No
|
No
|
2018/12/19
(TA)
|
--
|
TORRENT PHARMS LTD |
None (Tentative Approval) |
| METFORMIN HYDROCHLORIDE |
209993 |
001 |
ANDA |
METFORMIN HYDROCHLORIDE |
TABLET, EXTENDED RELEASE;ORAL |
500MG |
No
|
No
|
2018/12/27
|
2018/12/27
|
QINGDAO BAHEAL PHARM |
Prescription |
| METFORMIN HYDROCHLORIDE |
209993 |
002 |
ANDA |
METFORMIN HYDROCHLORIDE |
TABLET, EXTENDED RELEASE;ORAL |
1GM |
No
|
No
|
2018/12/27
|
2018/12/27
|
QINGDAO BAHEAL PHARM |
Prescription |
| METFORMIN HYDROCHLORIDE |
212969 |
001 |
ANDA |
METFORMIN HYDROCHLORIDE |
TABLET, EXTENDED RELEASE;ORAL |
500MG |
No
|
No
|
2019/11/25
|
2019/11/25
|
GLENMARK PHARMS LTD |
Prescription |
| METFORMIN HYDROCHLORIDE |
212969 |
002 |
ANDA |
METFORMIN HYDROCHLORIDE |
TABLET, EXTENDED RELEASE;ORAL |
1GM |
No
|
No
|
2019/11/25
|
2019/11/25
|
GLENMARK PHARMS LTD |
Prescription |
| ALOGLIPTIN AND METFORMIN HYDROCHLORIDE |
210212 |
001 |
ANDA |
ALOGLIPTIN AND METFORMIN HYDROCHLORIDE |
TABLET; ORAL |
12.5MG/500MG |
No
|
No
|
2019/11/27
(TA)
|
--
|
MSN LABORATORIES PRIVATE LTD |
None (Tentative Approval) |