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FDA NDA · NDA218213

AUGTYRO

repotrectinib

Sponsor: BRISTOL

APPLICATION
NDA218213
TYPE
NDA
ORIGINAL APPROVAL
2023-11-15
LATEST ACTION
2024-06-13
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Prescription

Products

AUGTYRO · ReferencePrescription
REPOTRECTINIB 160MG · CAPSULE · ORAL
AUGTYRO · ReferencePrescription
REPOTRECTINIB 40MG · CAPSULE · ORAL

Approval history

2024-06-13Efficacy · Supplement 1 · priority — Label ↗AP
2023-11-15Type 1 - New Molecular Entity · Original · priority — Review ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

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Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.

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