← FDA Drug Approvals (Drugs@FDA)
IBTROZI
NDA · New Drug Application · Sponsor: NUVATION · Approved 2025-06-11
Drug application
- FDA Application #
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
- Authoritative
- Drugs@FDA application overview
- Machine
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