Suboxone

INDIVIOR INC.🇺🇸 United States

FDA Page

Effective Date: Dec 18, 2023
Approval ID: 8a5edcf9-828c-4f97-b671-268ab13a8ecd
Products: 4 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 SUBOXONE sublingual film safely and effectively. See full prescribing information for SUBOXONE sublingual film.SUBOXONE (buprenorphine and naloxone) sublingual film, for sublingual or buccal use, CIIIInitial U.S. Approval: 2002

Quick Stats

Total Products4

Labelers2

Label Sections21

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.