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
30MG/100ML (0.3MG/ML)
Dosage form
SOLUTION
Route
INTRAVENOUS
TE code
Not listed
Application
ANDA 218354
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 215917 · DR REDDYS
- 2024EDARAVONEGeneric (ANDA)
ANDA 216199 · GLAND
- 2024EDARAVONEGeneric (ANDA)
ANDA 215508 · HIKMA
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.
