APPLICATION
ANDA211344
TYPE
ANDA
ORIGINAL APPROVAL
2021-03-31
LATEST ACTION
2025-02-05
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Discontinued
Products
IBRUTINIBDiscontinued
IBRUTINIB 140MG · CAPSULE · ORAL
IBRUTINIBDiscontinued
IBRUTINIB 70MG · CAPSULE · ORAL
Approval history
2025-02-05Labeling · Supplement 3 · standardAP
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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