varenicline

Major Pharmaceuticals🇺🇸 United States

FDA Page

Effective Date: Dec 15, 2023
Approval ID: 1297c291-da28-4a73-9c28-d5adee36d7b7
Products: 3 registered
Version: 1

Regulatory Information

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Status

Approved

Full Title

These highlights do not include all the information needed to use VARENICLINE TABLETS safely and effectively. See full prescribing information for VARENICLINE TABLETS. VARENICLINE tablets, for oral use Initial U.S. Approval: 2006

Quick Stats

Total Products3

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.