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General MedicationsINTRAVENOUSStandard

EDARAVONE

EDARAVONE

Standard Dose
60MG/100ML (0.6MG/ML)
Max Dose
Refer to approved labeling
Primary Use
Review priority: STANDARD Marketing status: Prescription
Summary

Approval overview EDARAVONE is listed in Drugs@FDA under application 217565 (ANDA).

Review priority: STANDARD Marketing status: Prescription Active ingredient EDARAVONE Form and strength SOLUTION;INTRAVENOUS - 60MG/100ML (0.6MG/ML) Sponsor PHARMOBEDIENT Submission history Latest submission status date: 2024-10-31 00:00:00.

Structured Monograph

Clinical summary

Approval overview EDARAVONE is listed in Drugs@FDA under application 217565 (ANDA). Review priority: STANDARD Marketing status: Prescription Active ingredient EDARAVONE Form and strength SOLUTION;INTRAVENOUS - 60MG/100ML (0.6MG/ML) Sponsor PHARMOBEDIENT Submission history Latest submission status date: 2024-10-31 00:00:00. Submission type: ORIG.

Monitoring

  • • Marketing status: Prescription
  • • Review priority: STANDARD

Interaction Notes

  • No interaction notes stored yet.