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General MedicationsSOLUTIONGeneric

EDARAVONE

EDARAVONE

Standard Dose
60mg/100mL
Max Dose
Refer to approved labeling
Primary Use
Review priority: STANDARD Marketing status: None (Tentative Approval)
Summary

Approval overview EDARAVONE is listed in Drugs@FDA under application 215508 (ANDA).

Review priority: STANDARD Marketing status: None (Tentative Approval) Active ingredient EDARAVONE Form and strength INJECTION;SOLUTION - 60mg/100mL Sponsor HIKMA Submission history Latest submission status date: 2024-05-06 00:00:00.

Structured Monograph

Clinical summary

Approval overview EDARAVONE is listed in Drugs@FDA under application 215508 (ANDA). Review priority: STANDARD Marketing status: None (Tentative Approval) Active ingredient EDARAVONE Form and strength INJECTION;SOLUTION - 60mg/100mL Sponsor HIKMA Submission history Latest submission status date: 2024-05-06 00:00:00. Submission type: ORIG.

Monitoring

  • • Marketing status: None (Tentative Approval)
  • • Review priority: STANDARD

Interaction Notes

  • No interaction notes stored yet.