| BENDAMUSTINE HYDROCHLORIDE |
204086 |
001 |
ANDA |
BENDAMUSTINE HYDROCHLORIDE |
POWDER;IV (INFUSION) |
25MG/VIAL |
No
|
No
|
2018/06/15
(TA)
|
--
|
HOSPIRA INC |
None (Tentative Approval) |
| BENDAMUSTINE HYDROCHLORIDE |
204086 |
002 |
ANDA |
BENDAMUSTINE HYDROCHLORIDE |
POWDER;IV (INFUSION) |
100MG/VIAL |
No
|
No
|
2018/06/15
(TA)
|
--
|
HOSPIRA INC |
None (Tentative Approval) |
| BENDAMUSTINE HYDROCHLORIDE |
205476 |
001 |
ANDA |
BENDAMUSTINE HYDROCHLORIDE |
POWDER;IV (INFUSION) |
25MG/VIAL |
No
|
No
|
2018/06/15
(TA)
|
--
|
INNOPHARMA LICENSING |
None (Tentative Approval) |
| BENDAMUSTINE HYDROCHLORIDE |
205476 |
002 |
ANDA |
BENDAMUSTINE HYDROCHLORIDE |
POWDER;IV (INFUSION) |
100MG/VIAL |
No
|
No
|
2018/06/15
(TA)
|
--
|
INNOPHARMA LICENSING |
None (Tentative Approval) |
| BENDAMUSTINE HYDROCHLORIDE |
210410 |
001 |
ANDA |
BENDAMUSTINE HYDROCHLORIDE |
SOLUTION;IV (INFUSION) |
100MG/4ML (25MG/ML) |
No
|
No
|
2018/11/13
(TA)
|
--
|
FRESENIUS KABI USA |
None (Tentative Approval) |
| BENDAMUSTINE HYDROCHLORIDE |
209814 |
001 |
ANDA |
BENDAMUSTINE HYDROCHLORIDE |
POWDER;IV (INFUSION) |
25MG/VIAL |
No
|
No
|
2019/01/25
(TA)
|
--
|
CELERITY PHARMS |
None (Tentative Approval) |
| BENDAMUSTINE HYDROCHLORIDE |
209814 |
002 |
ANDA |
BENDAMUSTINE HYDROCHLORIDE |
POWDER;IV (INFUSION) |
100MG/VIAL |
No
|
No
|
2019/01/25
(TA)
|
--
|
CELERITY PHARMS |
None (Tentative Approval) |
| BENDAMUSTINE HYDROCHLORIDE |
204771 |
001 |
ANDA |
BENDAMUSTINE HYDROCHLORIDE |
POWDER;IV (INFUSION) |
25MG/VIAL |
No
|
No
|
2019/02/20
(TA)
|
--
|
GLENMARK PHARMS LTD |
None (Tentative Approval) |
| BENDAMUSTINE HYDROCHLORIDE |
204771 |
002 |
ANDA |
BENDAMUSTINE HYDROCHLORIDE |
POWDER;IV (INFUSION) |
100MG/VIAL |
No
|
No
|
2019/02/20
(TA)
|
--
|
GLENMARK PHARMS LTD |
None (Tentative Approval) |
| BENDAMUSTINE HYDROCHLORIDE |
215668 |
001 |
NDA |
BENDAMUSTINE HYDROCHLORIDE |
SOLUTION;INTRAVENOUS |
100MG/4ML (25MG/ML) |
No
|
No
|
2021/11/12
(TA)
|
--
|
DR REDDYS LABS LTD |
None (Tentative Approval) |
| BENDAMUSTINE HYDROCHLORIDE |
205376 |
001 |
ANDA |
BENDAMUSTINE HYDROCHLORIDE |
POWDER;INTRAVENOUS |
25MG/VIAL |
No
|
No
|
2022/12/07
|
2022/12/07
|
DR REDDYS |
Prescription |
| BENDAMUSTINE HYDROCHLORIDE |
205376 |
002 |
ANDA |
BENDAMUSTINE HYDROCHLORIDE |
POWDER;INTRAVENOUS |
100MG/VIAL |
No
|
No
|
2022/12/07
|
2022/12/07
|
DR REDDYS |
Prescription |
| BENDAMUSTINE HYDROCHLORIDE |
205574 |
001 |
ANDA |
BENDAMUSTINE HYDROCHLORIDE |
POWDER;INTRAVENOUS |
25MG/VIAL |
No
|
No
|
2022/12/07
|
2022/12/07
|
ACCORD HLTHCARE |
Prescription |
| BENDAMUSTINE HYDROCHLORIDE |
205574 |
002 |
ANDA |
BENDAMUSTINE HYDROCHLORIDE |
POWDER;INTRAVENOUS |
100MG/VIAL |
No
|
No
|
2022/12/07
|
2022/12/07
|
ACCORD HLTHCARE |
Prescription |
| BENDAMUSTINE HYDROCHLORIDE |
215033 |
001 |
NDA |
BENDAMUSTINE HYDROCHLORIDE |
SOLUTION;INTRAVENOUS |
100MG/4ML (25MG/ML) |
Yes
|
Yes
|
2022/12/07
|
2022/12/07
|
APOTEX |
Prescription |
| BENDAMUSTINE HYDROCHLORIDE |
211530 |
001 |
NDA |
BENDAMUSTINE HYDROCHLORIDE |
SOLUTION;INTRAVENOUS |
25MG/ML (25MG/ML) |
Yes
|
No
|
2022/12/15
|
2022/12/15
|
HOSPIRA |
Discontinued |
| BENDAMUSTINE HYDROCHLORIDE |
211530 |
002 |
NDA |
BENDAMUSTINE HYDROCHLORIDE |
SOLUTION;INTRAVENOUS |
100MG/4ML (25MG/ML) |
Yes
|
No
|
2022/12/15
|
2022/12/15
|
HOSPIRA |
Discontinued |
| BENDAMUSTINE HYDROCHLORIDE |
211530 |
003 |
NDA |
BENDAMUSTINE HYDROCHLORIDE |
SOLUTION;INTRAVENOUS |
200MG/8ML (25MG/ML) |
Yes
|
No
|
2022/12/15
|
2022/12/15
|
HOSPIRA |
Discontinued |
| BENDAMUSTINE HYDROCHLORIDE |
216078 |
001 |
NDA |
BENDAMUSTINE HYDROCHLORIDE |
SOLUTION;INTRAVENOUS |
100MG/4ML (25MG/ML) |
Yes
|
Yes
|
2022/12/15
|
2022/12/15
|
BAXTER HLTHCARE CORP |
Prescription |
| BENDAMUSTINE HYDROCHLORIDE |
205447 |
001 |
ANDA |
BENDAMUSTINE HYDROCHLORIDE |
POWDER;INTRAVENOUS |
25MG/VIAL |
No
|
No
|
2023/02/14
|
2023/02/14
|
BRECKENRIDGE |
Discontinued |