| SUGAMMADEX SODIUM |
215701 |
001 |
ANDA |
SUGAMMADEX SODIUM |
INJECTABLE;INJECTION |
200MG/2ML(100MG/ML) |
No
|
No
|
2023/03/20
(TA)
|
--
|
SHANDONG |
None (Tentative Approval) |
| SUGAMMADEX SODIUM |
215701 |
002 |
ANDA |
SUGAMMADEX SODIUM |
INJECTABLE;INJECTION |
500MG/5ML(100MG/ML) |
No
|
No
|
2023/03/20
(TA)
|
--
|
SHANDONG |
None (Tentative Approval) |
| SUGAMMADEX SODIUM |
214337 |
001 |
ANDA |
SUGAMMADEX SODIUM |
SOLUTION;INTRAVENOUS |
EQ 200MG BASE/2ML (EQ 100MG BASE/ML) |
No
|
No
|
2023/06/09
|
2023/06/09
|
ASPIRO |
Prescription |
| SUGAMMADEX SODIUM |
214337 |
002 |
ANDA |
SUGAMMADEX SODIUM |
SOLUTION;INTRAVENOUS |
EQ 500MG BASE/5ML (EQ 100MG BASE/ML) |
No
|
No
|
2023/06/09
|
2023/06/09
|
ASPIRO |
Prescription |
| SUGAMMADEX SODIUM |
214290 |
001 |
ANDA |
SUGAMMADEX SODIUM |
SOLUTION;INTRAVENOUS |
EQ 200MG BASE/2ML (EQ 100MG BASE/ML) |
No
|
No
|
2023/10/04
|
2023/10/04
|
ZYDUS PHARMS |
Discontinued |
| SUGAMMADEX SODIUM |
214290 |
002 |
ANDA |
SUGAMMADEX SODIUM |
SOLUTION;INTRAVENOUS |
EQ 500MG BASE/5ML (EQ 100MG BASE/ML) |
No
|
No
|
2023/10/04
|
2023/10/04
|
ZYDUS PHARMS |
Discontinued |
| SUGAMMADEX |
213915 |
001 |
ANDA |
SUGAMMADEX |
INJECTABLE;INJECTION |
200MG/2ML |
No
|
No
|
2024/11/20
(TA)
|
--
|
MYLAN PHARMS INC |
None (Tentative Approval) |
| SUGAMMADEX |
213915 |
002 |
ANDA |
SUGAMMADEX |
INJECTABLE;INJECTION |
500MG/5ML |
No
|
No
|
2024/11/20
(TA)
|
--
|
MYLAN PHARMS INC |
None (Tentative Approval) |
| SUGAMMADEX |
214230 |
001 |
ANDA |
SUGAMMADEX |
INJECTABLE;INJECTION |
200MG/2ML(100MG/ML) |
No
|
No
|
2025/04/28
(TA)
|
--
|
MANKIND PHARMA |
None (Tentative Approval) |
| SUGAMMADEX |
214230 |
002 |
ANDA |
SUGAMMADEX |
INJECTABLE;INJECTION |
500MG/5ML(100MG/ML) |
No
|
No
|
2025/04/28
(TA)
|
--
|
MANKIND PHARMA |
None (Tentative Approval) |
| SUGAMMADEX |
214311 |
001 |
ANDA |
SUGAMMADEX |
INJECTABLE;INJECTION |
200MG/2ML |
No
|
No
|
2025/05/20
(TA)
|
--
|
SANDOZ INC |
None (Tentative Approval) |
| SUGAMMADEX |
214311 |
002 |
ANDA |
SUGAMMADEX |
INJECTABLE;INJECTION |
500MG/5ML |
No
|
No
|
2025/05/20
(TA)
|
--
|
SANDOZ INC |
None (Tentative Approval) |
| SUGAMMADEX |
218727 |
001 |
ANDA |
SUGAMMADEX |
INJECTION;SOLUTION |
100MG/ML |
No
|
No
|
2025/06/27
(TA)
|
--
|
HIKMA PHARMACEUTICALS USA INC |
None (Tentative Approval) |
| SUGAMMADEX |
215260 |
001 |
ANDA |
SUGAMMADEX |
INJECTION |
100MG/1ML |
No
|
No
|
2025/07/17
(TA)
|
--
|
TAMARANG SA |
None (Tentative Approval) |
| SUGAMMADEX SODIUM |
214279 |
001 |
ANDA |
SUGAMMADEX SODIUM |
SOLUTION;INTRAVENOUS |
EQ 200MG BASE/2ML (EQ 100MG BASE/ML) |
No
|
No
|
2025/08/05
|
2025/08/05
|
B BRAUN MEDICAL |
Prescription |
| SUGAMMADEX |
214319 |
002 |
ANDA |
SUGAMMADEX |
INJECTABLE;INJECTION |
EQ 200MG BASE/2ML (EQ 100MG BASE/ML) |
No
|
No
|
2025/09/18
(TA)
|
--
|
SUN PHARM INDS |
None (Tentative Approval) |