Zubsolv

Orexo US, Inc.🇺🇸 United States

FDA Page

Effective Date: Dec 17, 2023
Approval ID: 5f5cfcfe-d52b-49e6-8fe4-550477332dd2
Products: 6 registered
Version: 23

Regulatory Information

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Status

Approved

Full Title

These highlights do not include all the information needed to use ZUBSOLV safely and effectively. See full prescribing information for ZUBSOLV. ZUBSOLV (buprenorphine and naloxone sublingual tablets), CIII Initial U.S. Approval: 2002

Quick Stats

Total Products6

Labelers2

Label Sections34

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.