| EMPAGLIFLOZIN; LINAGLIPTIN |
212366 |
002 |
ANDA |
EMPAGLIFLOZIN;LINAGLIPTIN |
TABLET;ORAL |
25MG/5MG |
No
|
No
|
2022/08/09
(TA)
|
--
|
ALKEM LABS LTD |
None (Tentative Approval) |
| LINAGLIPTIN |
208448 |
001 |
ANDA |
LINAGLIPTIN |
TABLET;ORAL |
5MG |
No
|
No
|
2023/03/30
|
2023/03/30
|
ZYDUS PHARMS |
Prescription |
| LINAGLIPTIN AND METFORMIN HYDROCHLORIDE |
208449 |
001 |
ANDA |
LINAGLIPTIN; METFORMIN HYDROCHLORIDE |
TABLET;ORAL |
2.5MG;500MG |
No
|
No
|
2023/03/30
|
2023/03/30
|
ZYDUS PHARMS |
Prescription |
| LINAGLIPTIN AND METFORMIN HYDROCHLORIDE |
208449 |
002 |
ANDA |
LINAGLIPTIN; METFORMIN HYDROCHLORIDE |
TABLET;ORAL |
2.5MG;850MG |
No
|
No
|
2023/03/30
|
2023/03/30
|
ZYDUS PHARMS |
Prescription |
| 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 |
| 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) |
| LINAGLIPTIN |
208423 |
001 |
ANDA |
LINAGLIPTIN |
TABLET;ORAL |
5MG |
No
|
No
|
2024/09/03
|
2024/09/03
|
INVAGEN PHARMS |
Prescription |
| LINAGLIPTIN |
208415 |
001 |
ANDA |
LINAGLIPTIN |
TABLET;ORAL |
5MG |
No
|
No
|
2025/11/03
|
2025/11/03
|
AUROBINDO PHARMA LTD |
Prescription |
| LINAGLIPTIN AND METFORMIN HYDROCHLORIDE |
208427 |
001 |
ANDA |
LINAGLIPTIN; METFORMIN HYDROCHLORIDE |
TABLET;ORAL |
2.5MG;500MG |
No
|
No
|
2025/11/03
|
2025/11/03
|
DR REDDYS |
Prescription |
| LINAGLIPTIN AND METFORMIN HYDROCHLORIDE |
208427 |
002 |
ANDA |
LINAGLIPTIN; METFORMIN HYDROCHLORIDE |
TABLET;ORAL |
2.5MG;850MG |
No
|
No
|
2025/11/03
|
2025/11/03
|
DR REDDYS |
Prescription |
| LINAGLIPTIN AND METFORMIN HYDROCHLORIDE |
208427 |
003 |
ANDA |
LINAGLIPTIN; METFORMIN HYDROCHLORIDE |
TABLET;ORAL |
2.5MG;1GM |
No
|
No
|
2025/11/03
|
2025/11/03
|
DR REDDYS |
Prescription |
| LINAGLIPTIN |
208428 |
001 |
ANDA |
LINAGLIPTIN |
TABLET;ORAL |
5MG |
No
|
No
|
2025/11/03
|
2025/11/03
|
DR REDDYS |
Prescription |
| LINAGLIPTIN |
208431 |
001 |
ANDA |
LINAGLIPTIN |
TABLET;ORAL |
5MG |
No
|
No
|
2025/11/03
|
2025/11/03
|
MYLAN |
Prescription |
| LINAGLIPTIN |
208457 |
001 |
ANDA |
LINAGLIPTIN |
TABLET;ORAL |
5MG |
No
|
No
|
2025/11/03
|
2025/11/03
|
MSN |
Prescription |
| LINAGLIPTIN AND METFORMIN HYDROCHLORIDE |
208459 |
001 |
ANDA |
LINAGLIPTIN; METFORMIN HYDROCHLORIDE |
TABLET;ORAL |
2.5MG;500MG |
No
|
No
|
2025/11/03
|
2025/11/03
|
MSN |
Prescription |
| LINAGLIPTIN AND METFORMIN HYDROCHLORIDE |
208459 |
002 |
ANDA |
LINAGLIPTIN; METFORMIN HYDROCHLORIDE |
TABLET;ORAL |
2.5MG;850MG |
No
|
No
|
2025/11/03
|
2025/11/03
|
MSN |
Prescription |
| LINAGLIPTIN AND METFORMIN HYDROCHLORIDE |
208459 |
003 |
ANDA |
LINAGLIPTIN; METFORMIN HYDROCHLORIDE |
TABLET;ORAL |
2.5MG;1GM |
No
|
No
|
2025/11/03
|
2025/11/03
|
MSN |
Prescription |