Gadoterate Meglumine

Fresenius Kabi USA, LLC🇺🇸 United States

FDA Page

Effective Date: Jan 31, 2024
Approval ID: e0655aac-9508-4141-94f5-fcca6af1c41d
Products: 5 registered
Version: 3

Regulatory Information

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Status

Approved

Full Title

These highlights do not include all the information needed to use GADOTERATE MEGLUMINE INJECTION safely and effectively. See full prescribing information for GADOTERATE MEGLUMINE INJECTION. GADOTERATE MEGLUMINE injection for intravenous usePHARMACY BULK PACKAGE NOT FOR DIRECT INFUSIONInitial U.S. Approval: 2013

Quick Stats

Total Products5

Labelers2

Label Sections50

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.