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FDA NDA · NDA213217

BRUKINSA

zanubrutinib

Sponsor: BEONE MEDICINES USA

APPLICATION
NDA213217
TYPE
NDA
ORIGINAL APPROVAL
2019-11-14
LATEST ACTION
2025-01-24
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Discontinued

Products

BRUKINSA · ReferenceDiscontinued
ZANUBRUTINIB 80MG · CAPSULE · ORAL

Approval history

2025-01-24Labeling · Supplement 15 · standard — Label ↗AP
2024-06-04Labeling · Supplement 14 · 901 required — Letter ↗AP
2024-03-07Efficacy · Supplement 11 · standard — Label ↗AP
2023-12-21Efficacy · Supplement 9 · standard — Label ↗AP
2023-04-21Labeling · Supplement 10 · standard — Letter ↗AP
2023-01-19Efficacy · Supplement 7 · standard — Label ↗AP
2021-09-14Efficacy · Supplement 5 · priority — Label ↗AP
2021-08-31Efficacy · Supplement 4 · standard — Letter ↗AP
2019-11-14Type 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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