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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 219713
Company: NUVATION

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
IBTROZI TALETRECTINIB ADIPATE EQ 200MG BASE CAPSULE;ORAL Prescription None Yes Yes

Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
06/11/2025 ORIG-1 Approval Type 1 - New Molecular Entity PRIORITY; Orphan Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/219713s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/219713Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2025/219713Orig1s000TOC.html
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
09/16/2026 SUPPL-4 Efficacy-Labeling Change With Clinical Data

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert		 Note Url
06/11/2025 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/219713s000lbl.pdf
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