buprenorphine and naloxone

Hikma Pharmaceuticals USA Inc.🇺🇸 United States

FDA Page

Effective Date: Jul 26, 2026
Approval ID: 713db2c6-0544-4633-b874-cfbeaf93db89
Products: 2 registered
Version: 32

Regulatory Information

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Status

Approved

Full Title

These highlights do not include all the information needed to use BUPRENORPHINE and NALOXONE SUBLINGUAL TABLETS safely and effectively. See full prescribing information for BUPRENORPHINE and NALOXONE SUBLINGUAL TABLETS. BUPRENORPHINE and NALOXONE sublingual tablets, for sublingual administration CIIIInitial U.S. Approval: 2002

Quick Stats

Total Products2

Labelers2

Label Sections36

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.