| LINAGLIPTIN AND METFORMIN HYDROCHLORIDE |
208449 |
003 |
ANDA |
LINAGLIPTIN; METFORMIN HYDROCHLORIDE |
TABLET;ORAL |
2.5MG;1GM |
No
|
No
|
2023/03/30
|
2023/03/30
|
ZYDUS PHARMS |
Prescription |
| METFORMIN HYDROCHLORIDE |
215629 |
001 |
ANDA |
METFORMIN HYDROCHLORIDE |
TABLET, EXTENDED RELEASE;ORAL |
500MG |
No
|
No
|
2023/06/20
|
2023/06/20
|
RK PHARMA |
Prescription |
| METFORMIN HYDROCHLORIDE |
215629 |
002 |
ANDA |
METFORMIN HYDROCHLORIDE |
TABLET, EXTENDED RELEASE;ORAL |
1GM |
No
|
No
|
2023/06/20
|
2023/06/20
|
RK PHARMA |
Prescription |
| SAXAGLIPTIN AND METFORMIN HYDROCHLORIDE |
205981 |
001 |
ANDA |
METFORMIN HYDROCHLORIDE; SAXAGLIPTIN HYDROCHLORIDE |
TABLET, EXTENDED RELEASE;ORAL |
500MG;EQ 5MG BASE |
No
|
No
|
2023/07/31
|
2023/07/31
|
MYLAN |
Prescription |
| SAXAGLIPTIN AND METFORMIN HYDROCHLORIDE |
205981 |
002 |
ANDA |
METFORMIN HYDROCHLORIDE; SAXAGLIPTIN HYDROCHLORIDE |
TABLET, EXTENDED RELEASE;ORAL |
1GM;EQ 2.5MG BASE |
No
|
No
|
2023/07/31
|
2023/07/31
|
MYLAN |
Prescription |
| SAXAGLIPTIN AND METFORMIN HYDROCHLORIDE |
205981 |
003 |
ANDA |
METFORMIN HYDROCHLORIDE; SAXAGLIPTIN HYDROCHLORIDE |
TABLET, EXTENDED RELEASE;ORAL |
1GM;EQ 5MG BASE |
No
|
No
|
2023/07/31
|
2023/07/31
|
MYLAN |
Prescription |
| SAXAGLIPTIN AND METFORMIN HYDROCHLORIDE |
206081 |
001 |
ANDA |
METFORMIN HYDROCHLORIDE; SAXAGLIPTIN HYDROCHLORIDE |
TABLET, EXTENDED RELEASE;ORAL |
500MG;EQ 5MG BASE |
No
|
No
|
2023/07/31
|
2023/07/31
|
SUN PHARM |
Discontinued |
| SAXAGLIPTIN AND METFORMIN HYDROCHLORIDE |
206081 |
002 |
ANDA |
METFORMIN HYDROCHLORIDE; SAXAGLIPTIN HYDROCHLORIDE |
TABLET, EXTENDED RELEASE;ORAL |
1GM;EQ 2.5MG BASE |
No
|
No
|
2023/07/31
|
2023/07/31
|
SUN PHARM |
Discontinued |
| SAXAGLIPTIN AND METFORMIN HYDROCHLORIDE |
206081 |
003 |
ANDA |
METFORMIN HYDROCHLORIDE; SAXAGLIPTIN HYDROCHLORIDE |
TABLET, EXTENDED RELEASE;ORAL |
1GM;EQ 5MG BASE |
No
|
No
|
2023/07/31
|
2023/07/31
|
SUN PHARM |
Discontinued |
| SAXAGLIPTIN AND METFORMIN HYDROCHLORIDE |
207678 |
001 |
ANDA |
METFORMIN HYDROCHLORIDE; SAXAGLIPTIN HYDROCHLORIDE |
TABLET, EXTENDED RELEASE;ORAL |
500MG;EQ 5MG BASE |
No
|
No
|
2023/08/09
|
2023/08/09
|
DR REDDYS LABS SA |
Prescription |
| SAXAGLIPTIN AND METFORMIN HYDROCHLORIDE |
207678 |
002 |
ANDA |
METFORMIN HYDROCHLORIDE; SAXAGLIPTIN HYDROCHLORIDE |
TABLET, EXTENDED RELEASE;ORAL |
1GM;EQ 2.5MG BASE |
No
|
No
|
2023/08/09
|
2023/08/09
|
DR REDDYS LABS SA |
Prescription |
| SAXAGLIPTIN AND METFORMIN HYDROCHLORIDE |
207678 |
003 |
ANDA |
METFORMIN HYDROCHLORIDE; SAXAGLIPTIN HYDROCHLORIDE |
TABLET, EXTENDED RELEASE;ORAL |
1GM;EQ 5MG BASE |
No
|
Yes
|
2023/08/09
|
2023/08/09
|
DR REDDYS LABS SA |
Prescription |
| 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 |
| METFORMIN HYDROCHLORIDE |
211163 |
001 |
ANDA |
METFORMIN HYDROCHLORIDE |
TABLET, EXTENDED RELEASE;ORAL |
1GM |
No
|
No
|
2024/03/13
|
2024/03/13
|
MACLEODS PHARMS LTD |
Discontinued |
| 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 |