Orange Book product · Generic (ANDA)
EDARAVONE
EDARAVONE
At a glance
May 06, 2024
Approved
Generic (ANDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
May 06, 2024
2 yr 2 mo ago
Today
Pharmaceutical detail
Active ingredient
EDARAVONE
Strength
60MG/100ML (0.6MG/ML)
Dosage form
SOLUTION
Route
INTRAVENOUS
TE code
Not listed
Application
ANDA 215917
Product number
001
Marketing status
DISCN
Reference listed drug (RLD)
No
Reference standard (RS)
No
Active-ingredient family
View full familyGeneric (ANDA) of EDARAVONE
- 2022RADICAVA ORSBrand (NDA)
NDA 215446 · SHIONOGI
- 2017RADICAVABrand (NDA)
NDA 209176 · SHIONOGI
- 2024EDARAVONEGeneric (ANDA)
ANDA 216902 · SANDOZ
- 2024EDARAVONEGeneric (ANDA)
ANDA 217565 · PHARMOBEDIENT
- 2024EDARAVONEGeneric (ANDA)
ANDA 216199 · GLAND
- 2024EDARAVONEGeneric (ANDA)
ANDA 215508 · HIKMA
- 2024EDARAVONEGeneric (ANDA)
ANDA 218354 · LONG GROVE PHARMS
Listed patents
No patents are listed against this product in the Orange Book. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.
