| CANAGLIFLOZIN AND METFORMIN HYDROCHLORIDE |
215255 |
003 |
ANDA |
METFORMIN HYDROCHLORIDE; CANAGLIFLOZIN |
TABLET, EXTENDED RELEASE |
150MG |
No
|
No
|
2025/10/01
(TA)
|
--
|
MACLEODS PHARMACEUTICALS LTD |
None (Tentative Approval) |
| CANAGLIFLOZIN AND METFORMIN HYDROCHLORIDE |
215255 |
004 |
ANDA |
METFORMIN HYDROCHLORIDE; CANAGLIFLOZIN |
TABLET, EXTENDED RELEASE |
500MG |
No
|
No
|
2025/10/01
(TA)
|
--
|
MACLEODS PHARMACEUTICALS LTD |
None (Tentative Approval) |
| SITAGLIPTIN AND METFORMIN HYDROCHLORIDE |
212869 |
002 |
ANDA |
SITAGLIPTIN, METFORMIN HYDROCHLORIDE |
TABLET, EXTENDED RELEASE |
100MG |
No
|
No
|
2025/10/15
(TA)
|
--
|
SINOTHERAPEUTICS INC |
None (Tentative Approval) |
| SITAGLIPTIN AND METFORMIN HYDROCHLORIDE |
212869 |
003 |
ANDA |
SITAGLIPTIN, METFORMIN HYDROCHLORIDE |
TABLET, EXTENDED RELEASE |
500MG |
No
|
No
|
2025/10/15
(TA)
|
--
|
SINOTHERAPEUTICS INC |
None (Tentative Approval) |
| SITAGLIPTIN AND METFORMIN HYDROCHLORIDE |
212869 |
004 |
ANDA |
SITAGLIPTIN, METFORMIN HYDROCHLORIDE |
TABLET, EXTENDED RELEASE |
50MG |
No
|
No
|
2025/10/15
(TA)
|
--
|
SINOTHERAPEUTICS INC |
None (Tentative Approval) |
| 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 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 |
| SITAGLIPTIN AND METFORMIN HYDROCHLORIDE |
217395 |
002 |
ANDA |
SITAGLIPTIN PHOSPHATE ANHYDROUS, METFORMIN HYDROCHLORIDE |
TABLET |
100MG |
No
|
No
|
2025/11/17
(TA)
|
--
|
MSN LABORATORIES PRIVATE LTD |
None (Tentative Approval) |
| SITAGLIPTIN AND METFORMIN HYDROCHLORIDE |
217395 |
003 |
ANDA |
SITAGLIPTIN PHOSPHATE ANHYDROUS, METFORMIN HYDROCHLORIDE |
TABLET |
500MG |
No
|
No
|
2025/11/17
(TA)
|
--
|
MSN LABORATORIES PRIVATE LTD |
None (Tentative Approval) |
| SITAGLIPTIN AND METFORMIN HYDROCHLORIDE |
217395 |
004 |
ANDA |
SITAGLIPTIN PHOSPHATE ANHYDROUS, METFORMIN HYDROCHLORIDE |
TABLET |
50MG |
No
|
No
|
2025/11/17
(TA)
|
--
|
MSN LABORATORIES PRIVATE LTD |
None (Tentative Approval) |
| SITAGLIPTIN AND METFORMIN HYDROCHLORIDE |
217017 |
002 |
ANDA |
METFORMIN HYDROCHLORIDE, SITAGLIPTIN PHOSPHATE |
TABLET, EXTENDED RELEASE |
100MG |
No
|
No
|
2025/11/26
(TA)
|
--
|
ZHEJIANG JIUZHOU BIOPHARMA CO., LTD. |
None (Tentative Approval) |
| SITAGLIPTIN AND METFORMIN HYDROCHLORIDE |
217017 |
003 |
ANDA |
METFORMIN HYDROCHLORIDE, SITAGLIPTIN PHOSPHATE |
TABLET, EXTENDED RELEASE |
500MG |
No
|
No
|
2025/11/26
(TA)
|
--
|
ZHEJIANG JIUZHOU BIOPHARMA CO., LTD. |
None (Tentative Approval) |
| SITAGLIPTIN AND METFORMIN HYDROCHLORIDE |
217017 |
004 |
ANDA |
METFORMIN HYDROCHLORIDE, SITAGLIPTIN PHOSPHATE |
TABLET, EXTENDED RELEASE |
50MG |
No
|
No
|
2025/11/26
(TA)
|
--
|
ZHEJIANG JIUZHOU BIOPHARMA CO., LTD. |
None (Tentative Approval) |