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General MedicationsSUBCUTANEOUSStandard

FORZINITY

ELAMIPRETIDE HYDROCHLORIDE

Standard Dose
EQ 280MG BASE/3.5ML (EQ 80MG BASE/ML)
Max Dose
Refer to approved labeling
Primary Use
Review priority: PRIORITY Marketing status: Prescription
Summary

Approval overview FORZINITY is listed in Drugs@FDA under application 215244 (NDA).

Review priority: PRIORITY Marketing status: Prescription Active ingredient ELAMIPRETIDE HYDROCHLORIDE Form and strength SOLUTION;SUBCUTANEOUS - EQ 280MG BASE/3.5ML (EQ 80MG BASE/ML) Sponsor STEALTH BIOTHERAPS Submission history Latest submission status date: 2025-09-19 00:00:00.

Structured Monograph

Clinical summary

Approval overview FORZINITY is listed in Drugs@FDA under application 215244 (NDA). Review priority: PRIORITY Marketing status: Prescription Active ingredient ELAMIPRETIDE HYDROCHLORIDE Form and strength SOLUTION;SUBCUTANEOUS - EQ 280MG BASE/3.5ML (EQ 80MG BASE/ML) Sponsor STEALTH BIOTHERAPS Submission history Latest submission status date: 2025-09-19 00:00:00. Submission type: ORIG.

Monitoring

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

Interaction Notes

  • No interaction notes stored yet.