← FDA DRUG APPROVALS

FDA NDA · NDA205552

IMBRUVICA

ibrutinib

Sponsor: PHARMACYCLICS LLC

APPLICATION
NDA205552
TYPE
NDA
ORIGINAL APPROVAL
2013-11-13
LATEST ACTION
2025-10-21
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Prescription

Products

IMBRUVICA · ReferencePrescription
IBRUTINIB 70MG · CAPSULE · ORAL
IMBRUVICA · ReferencePrescription
IBRUTINIB 140MG · CAPSULE · ORAL

Approval history

2025-10-21Labeling · Supplement 44 · standard — Label ↗AP
2024-12-20Labeling · Supplement 43 · standard — Letter ↗AP
2024-05-09Labeling · Supplement 42 · 901 required — Letter ↗AP
2023-05-18Efficacy · Supplement 40 · standard — Letter ↗AP
2022-08-24Efficacy · Supplement 38 · priority — Label ↗AP
2022-08-24Efficacy · Supplement 36 · priority — Label ↗AP
2022-08-24Efficacy · Supplement 37 · standardAP
2022-05-11Labeling · Supplement 35 · standard — Label ↗AP
2020-12-22Labeling · Supplement 33 · standard — Letter ↗AP
2020-12-18Efficacy · Supplement 32 · standard — Letter ↗AP
2020-08-07Labeling · Supplement 31 · standard — Letter ↗AP
2020-04-21Efficacy · Supplement 30 · priority — Label ↗AP
2019-11-21Labeling · Supplement 29 · standard — Label ↗AP
2019-07-15Labeling · Supplement 28 · standard — Letter ↗AP
2019-01-25Efficacy · Supplement 26 · priority — Label ↗AP
2018-08-24Efficacy · Supplement 24 · priority — Label ↗AP
2018-08-24Labeling · Supplement 25 · standard — Label ↗AP
2017-12-20Efficacy · Supplement 20 · priority — Label ↗AP
2017-08-02Efficacy · Supplement 17 · priority — Label ↗AP
2017-07-10Manufacturing (CMC) · Supplement 18 — Letter ↗AP
2017-01-18Efficacy · Supplement 16 · priority — Letter ↗AP
2016-06-28Labeling · Supplement 12 · standard — Label ↗AP
2016-06-27Manufacturing (CMC) · Supplement 14 · priorityAP
2016-05-06Efficacy · Supplement 10 · priority — Label ↗AP
2016-05-06Efficacy · Supplement 13 · priority — Label ↗AP
2016-04-13Manufacturing (CMC) · Supplement 11 · priorityAP
2016-03-21Manufacturing (CMC) · Supplement 6 · priorityAP
2016-03-04Efficacy · Supplement 7 · priority — Label ↗AP
2016-02-08Manufacturing (CMC) · Supplement 8 · priorityAP
2015-11-25Manufacturing (CMC) · Supplement 9 · priorityAP
2015-08-24Manufacturing (CMC) · Supplement 5 · priorityAP
2015-08-17Manufacturing (CMC) · Supplement 4 · priorityAP
2015-08-13Manufacturing (CMC) · Supplement 3 · priority — Letter ↗AP
2015-01-29Efficacy · Supplement 2 · priority — Label ↗AP
2014-07-28Efficacy · Supplement 1 · priority — Label ↗AP
2014-02-12Efficacy · Original · priority — Label ↗AP
2013-11-13Type 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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