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General MedicationsORALStandard

IQIRVO

ELAFIBRANOR

Standard Dose
80MG
Max Dose
Refer to approved labeling
Primary Use
Review priority: PRIORITY Marketing status: Prescription
Summary

Approval overview IQIRVO is listed in Drugs@FDA under application 218860 (NDA).

Review priority: PRIORITY Marketing status: Prescription Active ingredient ELAFIBRANOR Form and strength TABLET;ORAL - 80MG Sponsor IPSEN Submission history Latest submission status date: 2024-06-10 00:00:00.

Structured Monograph

Clinical summary

Approval overview IQIRVO is listed in Drugs@FDA under application 218860 (NDA). Review priority: PRIORITY Marketing status: Prescription Active ingredient ELAFIBRANOR Form and strength TABLET;ORAL - 80MG Sponsor IPSEN Submission history Latest submission status date: 2024-06-10 00:00:00. Submission type: ORIG.

Monitoring

  • Marketing status: Prescription
  • Review priority: PRIORITY

Interaction Notes

  • No interaction notes stored yet.