← FDA DRUG APPROVALS

FDA NDA · NDA213411

TUKYSA

tucatinib

Sponsor: SEAGEN

APPLICATION
NDA213411
TYPE
NDA
ORIGINAL APPROVAL
2020-04-17
LATEST ACTION
2023-01-19
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription

Products

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

Approval history

2023-01-19Efficacy · Supplement 4 · priority — Label ↗AP
2020-04-17Type 1 - New Molecular Entity · Original · priority — Label ↗AP
VIEW ON DRUGS@FDA ↗

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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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