Ambien

sanofi-aventis U.S. LLC🇺🇸 United States

FDA Page

Effective Date: Feb 12, 2019
Approval ID: c36cadf4-65a4-4466-b409-c82020b42452
Products: 2 registered
Version: 21

Regulatory Information

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Status

Approved

Full Title

These highlights do not include all the information needed to use AMBIEN safely and effectively. See full prescribing information for AMBIEN. AMBIEN (zolpidem tartrate) tablets, for oral use, C-IV Initial U.S. Approval: 1992

Quick Stats

Total Products2

Labelers2

Label Sections22

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.