| CANAGLIFLOZIN |
210297 |
001 |
ANDA |
CANAGLIFLOZIN |
TABLET; ORAL |
100MG |
No
|
No
|
2020/11/20
(TA)
|
--
|
SANDOZ INC |
None (Tentative Approval) |
| CANAGLIFLOZIN |
210451 |
002 |
ANDA |
CANAGLIFLOZIN |
TABLET; ORAL |
300mg |
No
|
No
|
2022/06/14
(TA)
|
--
|
TEVA PHARMS USA |
None (Tentative Approval) |
| CANAGLIFLOZIN |
210541 |
001 |
ANDA |
CANAGLIFLOZIN |
TABLET;ORAL |
100MG |
No
|
No
|
2023/02/13
(TA)
|
--
|
ZYDUS PHARMS USA INC |
None (Tentative Approval) |
| CANAGLIFLOZIN |
210541 |
002 |
ANDA |
CANAGLIFLOZIN |
TABLET;ORAL |
300MG |
No
|
No
|
2023/02/13
(TA)
|
--
|
ZYDUS PHARMS USA INC |
None (Tentative Approval) |
| CANAGLIFLOZIN; METFORMIN HYDROCHLORIDE |
210542 |
001 |
ANDA |
CANAGLIFLOZIN;METFORMIN HYDROCHLORIDE |
TABLET;ORAL |
50MG;500MG |
No
|
No
|
2023/02/16
(TA)
|
--
|
ZYDUS PHARMS USA INC |
None (Tentative Approval) |
| CANAGLIFLOZIN; METFORMIN HYDROCHLORIDE |
210542 |
002 |
ANDA |
CANAGLIFLOZIN;METFORMIN HYDROCHLORIDE |
TABLET;ORAL |
50MG;1000MG |
No
|
No
|
2023/02/16
(TA)
|
--
|
ZYDUS PHARMS USA INC |
None (Tentative Approval) |
| CANAGLIFLOZIN; METFORMIN HYDROCHLORIDE |
210542 |
003 |
ANDA |
CANAGLIFLOZIN;METFORMIN HYDROCHLORIDE |
TABLET;ORAL |
150MG;500MG |
No
|
No
|
2023/02/16
(TA)
|
--
|
ZYDUS PHARMS USA INC |
None (Tentative Approval) |
| CANAGLIFLOZIN; METFORMIN HYDROCHLORIDE |
210542 |
004 |
ANDA |
CANAGLIFLOZIN;METFORMIN HYDROCHLORIDE |
TABLET;ORAL |
150MG;1000MG |
No
|
No
|
2023/02/16
(TA)
|
--
|
ZYDUS PHARMS USA INC |
None (Tentative Approval) |
| CANAGLIFLOZIN |
210503 |
002 |
ANDA |
CANAGLIFLOZIN |
TABLET;ORAL |
300MG |
No
|
No
|
2025/09/29
(TA)
|
--
|
LAURUS LABS LTD |
None (Tentative Approval) |
| CANAGLIFLOZIN AND METFORMIN HYDROCHLORIDE |
215255 |
001 |
ANDA |
METFORMIN HYDROCHLORIDE; CANAGLIFLOZIN |
TABLET, EXTENDED RELEASE |
1000MG |
No
|
No
|
2025/10/01
(TA)
|
--
|
MACLEODS PHARMACEUTICALS LTD |
None (Tentative Approval) |
| CANAGLIFLOZIN AND METFORMIN HYDROCHLORIDE |
215255 |
002 |
ANDA |
METFORMIN HYDROCHLORIDE; CANAGLIFLOZIN |
TABLET, EXTENDED RELEASE |
50MG |
No
|
No
|
2025/10/01
(TA)
|
--
|
MACLEODS PHARMACEUTICALS LTD |
None (Tentative Approval) |
| 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) |