Orange Book product · Brand (NDA)
RADICAVA
EDARAVONE
At a glance
May 05, 2017
Approved
Brand (NDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
May 05, 2017
9 yr 3 mo ago
Today
Pharmaceutical detail
Active ingredient
EDARAVONE
Strength
30MG/100ML (0.3MG/ML)
Dosage form
SOLUTION
Route
INTRAVENOUS
TE code
Not listed
Application
NDA 209176
Product number
001
Marketing status
DISCN
Reference listed drug (RLD)
Yes
Reference standard (RS)
No
Active-ingredient family
View full familyThis is a reference-listed drug (RLD) — the basis for generic (ANDA) applications. Other products sharing this ingredient are listed below.
- 2022RADICAVA ORSBrand (NDA)
NDA 215446 · 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
- 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.
