PREZCOBIX

Janssen Products LP🇺🇸 United States

FDA Page

Effective Date: Feb 1, 2026
Approval ID: 9c38fdb6-d0ba-4f16-a0e3-85d9ec334d9f
Products: 3 registered
Version: 29

Regulatory Information

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Status

Approved

Full Title

These highlights do not include all the information needed to use PREZCOBIX safely and effectively. See full prescribing information for PREZCOBIX. PREZCOBIX (darunavir and cobicistat) tablets, for oral use PREZCOBIX PED (darunavir and cobicistat) tablets for oral suspension Initial U.S. Approval: 2015

Quick Stats

Total Products3

Labelers3

Label Sections39

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.