Orange Book product · Generic (ANDA)
EDARAVONE
EDARAVONE
At a glance
Dec 23, 2024
Approved
Generic (ANDA)
Application
AP
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Dec 23, 2024
1 yr 6 mo ago
Today
Pharmaceutical detail
Active ingredient
EDARAVONE
Strength
30MG/100ML (0.3MG/ML)
Dosage form
SOLUTION
Route
INTRAVENOUS
TE code
AP
Application
ANDA 216902
Product number
001
Marketing status
RX
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 217565 · PHARMOBEDIENT
- 2024EDARAVONEGeneric (ANDA)
ANDA 215917 · DR REDDYS
- 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.
