APPLICATION
NDA218785
TYPE
NDA
ORIGINAL APPROVAL
2025-06-10
LATEST ACTION
2025-06-10
ROUTE
ORAL
DOSAGE FORM
CAPSULE, TABLET
MARKETING STATUS
Prescription
Products
BRUKINSAPrescription
ZANUBRUTINIB 80MG · CAPSULE · ORAL
BRUKINSA · ReferencePrescription
ZANUBRUTINIB 160MG · TABLET · ORAL
Approval history
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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