| CABAZITAXEL |
207937 |
001 |
NDA |
CABAZITAXEL |
INJECTABLE;INJECTION |
20MG/ML |
No
|
No
|
2019/11/22
(TA)
|
--
|
FRESENIUS KABI USA |
None (Tentative Approval) |
| CABAZITAXEL |
207949 |
001 |
NDA |
CABAZITAXEL |
SOLUTION;INTRAVENOUS |
60MG/3ML (20MG/ML) |
Yes
|
Yes
|
2021/12/29
|
2021/12/29
|
ACCORD HLTHCARE |
Prescription |
| CABAZITAXEL |
207619 |
001 |
ANDA |
CABAZITAXEL |
SOLUTION;INTRAVENOUS |
60MG/1.5ML (40MG/ML) |
No
|
No
|
2022/06/23
|
2022/06/23
|
BRECKENRIDGE |
Discontinued |
| CABAZITAXEL |
207693 |
001 |
ANDA |
CABAZITAXEL |
SOLUTION;INTRAVENOUS |
60MG/1.5ML (40MG/ML) |
No
|
No
|
2022/10/26
|
2022/10/26
|
ACCORD HLTHCARE |
Prescription |
| CABAZITAXEL |
207718 |
001 |
ANDA |
CABAZITAXEL |
SOLUTION;INTRAVENOUS |
60MG/1.5ML (40MG/ML) |
No
|
No
|
2023/02/10
|
2023/02/10
|
DR REDDYS |
Prescription |
| CABAZITAXEL |
207736 |
001 |
ANDA |
CABAZITAXEL |
SOLUTION;INTRAVENOUS |
60MG/1.5ML (40MG/ML) |
No
|
No
|
2023/02/10
|
2023/02/10
|
APOTEX |
Discontinued |
| CABAZITAXEL |
207735 |
001 |
ANDA |
CABAZITAXEL |
UNKNOWN |
UNKNOWN |
No
|
No
|
2023/03/22
(TA)
|
--
|
BPI LABS LLC |
None (Tentative Approval) |
| CABAZITAXEL |
207381 |
001 |
ANDA |
CABAZITAXEL |
SOLUTION;INTRAVENOUS |
60MG/1.5ML (40MG/ML) |
No
|
No
|
2023/07/05
|
2023/07/05
|
MYLAN LABS LTD |
Discontinued |
| CABAZITAXEL |
208715 |
001 |
NDA |
CABAZITAXEL |
SOLUTION;INTRAVENOUS |
45MG/4.5ML (10MG/ML) |
Yes
|
Yes
|
2023/10/27
(TA)
|
--
|
SANDOZ |
None (Tentative Approval) |
| CABAZITAXEL |
208715 |
002 |
NDA |
CABAZITAXEL |
SOLUTION;INTRAVENOUS |
60MG/6ML (10MG/ML) |
Yes
|
Yes
|
2023/10/27
(TA)
|
--
|
SANDOZ |
None (Tentative Approval) |
| CABAZITAXEL |
207970 |
001 |
NDA |
CABAZITAXEL |
SOLUTION;INTRAVENOUS |
60MG/6ML (10MG/ML) |
Yes
|
Yes
|
2024/03/14
|
2024/03/14
|
ACTAVIS |
Prescription |
| CABAZITAXEL INJECTION |
207970 |
002 |
NDA |
CABAZITAXEL |
INJECTABLE;INJECTION |
60MG/6ML |
No
|
No
|
2024/03/14
|
--
|
ACTAVIS |
None (Tentative Approval) |