Buprenorphine and Naloxone

Alvogen Inc.🇺🇸 United States

FDA Page

Effective Date: Jan 1, 2026
Approval ID: 4210afeb-474c-d842-d68e-af7e0021851a
Products: 4 registered
Version: 19

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 FILM safely and effectively. See full prescribing information for BUPRENORPHINE AND NALOXONE SUBLINGUAL FILM. BUPRENORPHINE and NALOXONE sublingual film, for sublingual or buccal use, CIIIInitial U.S. Approval: 2002

Quick Stats

Total Products4

Labelers2

Label Sections26

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.