# IBTROZI
> **NDA219713** · New Drug Application · Sponsor: NUVATION · Approved 2025-06-11
## Drug
- **FDA Application Number:** NDA219713
- **Application type:** New Drug Application
- **Brand name:** IBTROZI
- **Generic name:** TALETRECTINIB
- **Active ingredients:** TALETRECTINIB ADIPATE
- **Dosage form:** CAPSULE
- **Route:** ORAL
- **Marketing status:** Prescription
- **Sponsor:** NUVATION
- **Manufacturer:** Nuvation Bio Inc.
- **First approval:** 2025-06-11
## Source
- [Drugs@FDA application overview](https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=219713)
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