Imbruvica

Pharmacyclics LLC🇺🇸 United States

FDA Page

Effective Date: Dec 20, 2024
Approval ID: 0dfd0279-ff17-4ea9-89be-9803c71bab44
Products: 7 registered
Version: 53

Regulatory Information

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Status

Approved

Full Title

These highlights do not include all the information needed to use IMBRUVICA safely and effectively. See full prescribing information for IMBRUVICA. IMBRUVICA (ibrutinib) capsules, for oral use IMBRUVICA (ibrutinib) tablets, for oral use IMBRUVICA (ibrutinib) oral suspension Initial U.S. Approval: 2013

Quick Stats

Total Products7

Labelers2

Label Sections43

Regulatory Agency

🇺🇸

U.S. Food and Drug Administration

United States

Data Sources & Disclaimer: Approval information is sourced from official FDA databases. This content is for informational purposes only and does not constitute medical or regulatory advice. Always refer to official FDA websites for the most current information.