| METFORMIN HYDROCHLORIDE |
217631 |
001 |
ANDA |
METFORMIN HYDROCHLORIDE |
TABLET, EXTENDED RELEASE;ORAL |
500MG |
No
|
No
|
2023/10/05
|
2023/10/05
|
LAURUS |
Prescription |
| METFORMIN HYDROCHLORIDE |
217631 |
002 |
ANDA |
METFORMIN HYDROCHLORIDE |
TABLET, EXTENDED RELEASE;ORAL |
750MG |
No
|
No
|
2023/10/05
|
2023/10/05
|
LAURUS |
Prescription |
| EMPAGLIFLOZIN; LINAGLIPTIN; METFORMIN HYDROCHLORIDE |
217049 |
001 |
ANDA |
EMPAGLIFLOZIN;LINAGLIPTIN;METFORMIN HYDROCHLORIDE |
TABLET, EXTENDED RELEASE;ORAL |
5MG;2.5MG;1000MG |
No
|
No
|
2024/03/06
(TA)
|
--
|
ZYDUS PHARMS USA INC |
None (Tentative Approval) |
| EMPAGLIFLOZIN; LINAGLIPTIN; METFORMIN HYDROCHLORIDE |
217049 |
002 |
ANDA |
EMPAGLIFLOZIN;LINAGLIPTIN;METFORMIN HYDROCHLORIDE |
TABLET, EXTENDED RELEASE;ORAL |
10MG;5MG;1000MG |
No
|
No
|
2024/03/06
(TA)
|
--
|
ZYDUS PHARMS USA INC |
None (Tentative Approval) |
| EMPAGLIFLOZIN; LINAGLIPTIN; METFORMIN HYDROCHLORIDE |
217049 |
003 |
ANDA |
EMPAGLIFLOZIN;LINAGLIPTIN;METFORMIN HYDROCHLORIDE |
TABLET, EXTENDED RELEASE;ORAL |
12.5MG;2.5MG;1000MG |
No
|
No
|
2024/03/06
(TA)
|
--
|
ZYDUS PHARMS USA INC |
None (Tentative Approval) |
| EMPAGLIFLOZIN; LINAGLIPTIN; METFORMIN HYDROCHLORIDE |
217049 |
004 |
ANDA |
EMPAGLIFLOZIN;LINAGLIPTIN;METFORMIN HYDROCHLORIDE |
TABLET, EXTENDED RELEASE;ORAL |
25MG;5MG;1000MG |
No
|
No
|
2024/03/06
(TA)
|
--
|
ZYDUS PHARMS USA INC |
None (Tentative Approval) |
| METFORMIN HYDROCHLORIDE |
211163 |
001 |
ANDA |
METFORMIN HYDROCHLORIDE |
TABLET, EXTENDED RELEASE;ORAL |
1GM |
No
|
No
|
2024/03/13
|
2024/03/13
|
MACLEODS PHARMS LTD |
Prescription |
| METFORMIN HYDROCHLORIDE |
218673 |
001 |
ANDA |
METFORMIN HYDROCHLORIDE |
TABLET, EXTENDED RELEASE;ORAL |
500MG |
No
|
No
|
2024/07/05
|
2024/07/05
|
HARMAN FINOCHEM |
Prescription |
| METFORMIN HYDROCHLORIDE |
218673 |
002 |
ANDA |
METFORMIN HYDROCHLORIDE |
TABLET, EXTENDED RELEASE;ORAL |
750MG |
No
|
No
|
2024/07/05
|
2024/07/05
|
HARMAN FINOCHEM |
Prescription |
| EMPAGLIFLOZIN; METFORMIN HYDROCHLORIDE |
218483 |
004 |
ANDA |
EMPAGLIFLOZIN;METFORMIN HYDROCHLORIDE |
TABLET;ORAL |
12.5MG;1000MG |
No
|
No
|
2024/10/15
(TA)
|
--
|
PRINSTON PHARMA INC |
None (Tentative Approval) |
| METFORMIN HYDROCHLORIDE |
209694 |
001 |
ANDA |
METFORMIN HYDROCHLORIDE |
TABLET, EXTENDED RELEASE;ORAL |
500MG |
No
|
No
|
2024/10/18
|
2024/10/18
|
AUROBINDO PHARMA |
Prescription |
| METFORMIN HYDROCHLORIDE |
209694 |
002 |
ANDA |
METFORMIN HYDROCHLORIDE |
TABLET, EXTENDED RELEASE;ORAL |
1GM |
No
|
No
|
2024/10/18
|
2024/10/18
|
AUROBINDO PHARMA |
Prescription |