DOTAREM

Guerbet LLC🇺🇸 United States

FDA Page

Effective Date: Jan 7, 2024
Approval ID: 82b83e61-6af8-4225-aa39-8cbf206f65b0
Products: 2 registered
Version: 15

Regulatory Information

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Status

Approved

Full Title

These highlights do not include all the information needed to use DOTAREM safely and effectively. See full prescribing information for DOTAREM. DOTAREM (gadoterate meglumine) Injection for intravenous usePHARMACY BULK PACKAGE NOT FOR DIRECT INFUSION Initial U.S. Approval: 2013

Quick Stats

Total Products2

Labelers2

Label Sections38

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.