← FDA DRUG APPROVALS

FDA NDA · NDA217003

IMBRUVICA

ibrutinib

Sponsor: PHARMACYCLICS LLC

APPLICATION
NDA217003
TYPE
NDA
ORIGINAL APPROVAL
2022-08-24
LATEST ACTION
2025-10-21
ROUTE
ORAL
DOSAGE FORM
SUSPENSION, TABLET, CAPSULE
MARKETING STATUS
Prescription

Products

IMBRUVICA · ReferencePrescription
IBRUTINIB 70MG/ML · SUSPENSION · ORAL
IMBRUVICAPrescription
IBRUTINIB 420MG · TABLET · ORAL
IMBRUVICAPrescription
IBRUTINIB 140MG · TABLET · ORAL
IMBRUVICAPrescription
IBRUTINIB 70MG · CAPSULE · ORAL
IMBRUVICAPrescription
IBRUTINIB 560MG · TABLET · ORAL
IMBRUVICAPrescription
IBRUTINIB 230MG · TABLET · ORAL
IMBRUVICAPrescription
IBRUTINIB 140MG · CAPSULE · ORAL

Approval history

2025-10-21Labeling · Supplement 5 · standard — Letter ↗AP
2024-12-20Labeling · Supplement 4 · standard — Letter ↗AP
2024-05-09Labeling · Supplement 3 · 901 required — Label ↗AP
2024-02-22Labeling · Supplement 2 · standard — Letter ↗AP
2022-08-24Type 5 - New Formulation or New Manufacturer · 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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