FDA NDA · NDA213411

TUKYSA

Sponsor: SEAGEN

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APPLICATION
NDA213411
TYPE
NDA
ORIGINAL APPROVAL
2020-04-17
LATEST ACTION
2026-10-07
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription

Products

TUKYSA · ReferencePrescription
TUCATINIB 50MG · TABLET · ORAL
TUKYSA · ReferencePrescription
TUCATINIB 150MG · TABLET · ORAL

Approval history

2026-10-07Efficacy · Supplement 10 · standard — Letter ↗AP
2023-01-19Efficacy · Supplement 4 · priority — Label ↗AP
2020-04-17Type 1 - New Molecular Entity · Original · priority — Label ↗AP