Xyrem

Jazz Pharmaceuticals, Inc.🇺🇸 United States

FDA Page

Effective Date: Apr 25, 2023
Approval ID: 926eb076-a4a8-45e4-91ef-411f0aa4f3ca
Products: 1 registered
Version: 24

Regulatory Information

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Status

Approved

Full Title

These highlights do not include all the information needed to use XYREM safely and effectively. See full prescribing information for XYREM. XYREM (sodium oxybate) oral solution, CIIIInitial U.S. Approval: 2002

Quick Stats

Total Products1

Labelers2

Label Sections19

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.