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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.