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General MedicationsORALStandard

FABHALTA

IPTACOPAN HYDROCHLORIDE

Standard Dose
EQ 200MG BASE
Max Dose
Refer to approved labeling
Primary Use
Review priority: PRIORITY Marketing status: Prescription
Summary

Approval overview FABHALTA is listed in Drugs@FDA under application 218276 (NDA).

Review priority: PRIORITY Marketing status: Prescription Active ingredient IPTACOPAN HYDROCHLORIDE Form and strength CAPSULE;ORAL - EQ 200MG BASE Sponsor NOVARTIS Submission history Latest submission status date: 2025-03-20 00:00:00.

Structured Monograph

Clinical summary

Approval overview FABHALTA is listed in Drugs@FDA under application 218276 (NDA). Review priority: PRIORITY Marketing status: Prescription Active ingredient IPTACOPAN HYDROCHLORIDE Form and strength CAPSULE;ORAL - EQ 200MG BASE Sponsor NOVARTIS Submission history Latest submission status date: 2025-03-20 00:00:00. Submission type: SUPPL.

Monitoring

  • • Marketing status: Prescription
  • • Review priority: PRIORITY

Interaction Notes

  • No interaction notes stored yet.