General MedicationsORALStandard
RADICAVA ORS
EDARAVONE
Standard Dose
105MG/5ML
Max Dose
Refer to approved labeling
Primary Use
Review priority: PRIORITY Marketing status: Prescription
Summary
Approval overview RADICAVA ORS is listed in Drugs@FDA under application 215446 (NDA).
Review priority: PRIORITY Marketing status: Prescription Active ingredient EDARAVONE Form and strength SUSPENSION;ORAL - 105MG/5ML Sponsor KK BCJ-94 Submission history Latest submission status date: 2022-05-12 00:00:00.
Structured Monograph
Clinical summary
Approval overview RADICAVA ORS is listed in Drugs@FDA under application 215446 (NDA). Review priority: PRIORITY Marketing status: Prescription Active ingredient EDARAVONE Form and strength SUSPENSION;ORAL - 105MG/5ML Sponsor KK BCJ-94 Submission history Latest submission status date: 2022-05-12 00:00:00. Submission type: ORIG.
Monitoring
- • Marketing status: Prescription
- • Review priority: PRIORITY
Interaction Notes
- No interaction notes stored yet.