← FDA DRUG APPROVALS

FDA NDA · NDA210563

IMBRUVICA

ibrutinib

Sponsor: PHARMACYCLICS LLC

APPLICATION
NDA210563
TYPE
NDA
ORIGINAL APPROVAL
2018-02-16
LATEST ACTION
2025-10-21
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued, Prescription

Products

IMBRUVICA · ReferenceDiscontinued
IBRUTINIB 560MG · TABLET · ORAL
IMBRUVICA · ReferencePrescription
IBRUTINIB 280MG · TABLET · ORAL
IMBRUVICA · ReferencePrescription
IBRUTINIB 420MG · TABLET · ORAL
IMBRUVICA · ReferencePrescription
IBRUTINIB 140MG · TABLET · ORAL

Approval history

2025-10-21Labeling · Supplement 20 · standard — Letter ↗AP
2024-12-20Labeling · Supplement 19 · standard — Letter ↗AP
2024-05-09Labeling · Supplement 18 · 901 required — Label ↗AP
2023-05-18Efficacy · Supplement 17 · standard — Letter ↗AP
2022-08-24Efficacy · Supplement 14 · priority — Label ↗AP
2022-08-24Efficacy · Supplement 12 · priority — Label ↗AP
2022-08-24Efficacy · Supplement 13 · priorityAP
2022-05-11Labeling · Supplement 11 · standard — Letter ↗AP
2020-12-22Labeling · Supplement 10 · standard — Letter ↗AP
2020-12-18Efficacy · Supplement 9 · standard — Letter ↗AP
2020-08-07Labeling · Supplement 7 · standard — Letter ↗AP
2020-04-21Efficacy · Supplement 6 · priority — Label ↗AP
2019-11-21Labeling · Supplement 4 · standard — Label ↗AP
2019-07-15Labeling · Supplement 3 · standard — Letter ↗AP
2019-01-25Efficacy · Supplement 2 · priority — Label ↗AP
2018-08-24Efficacy · Supplement 1 · priority — Label ↗AP
2018-02-16Type 3 - New Dosage Form · Original · priority — Label ↗AP
2018-02-16Efficacy · 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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