# FORZINITY
> **NDA215244** · New Drug Application · Sponsor: STEALTH BIOTHERAPS · Approved 2025-09-19
## Drug
- **FDA Application Number:** NDA215244
- **Application type:** New Drug Application
- **Brand name:** FORZINITY
- **Generic name:** ELAMIPRETIDE HYDROCHLORIDE
- **Active ingredients:** ELAMIPRETIDE HYDROCHLORIDE
- **Dosage form:** SOLUTION
- **Route:** SUBCUTANEOUS
- **Marketing status:** Prescription
- **Sponsor:** STEALTH BIOTHERAPS
- **Manufacturer:** Stealth Biotherapeutics Inc.
- **First approval:** 2025-09-19
## Source
- [Drugs@FDA application overview](https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=215244)
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