gadoterate meglumine

Slate Run Pharmaceuticals, LLC🇺🇸 United States

FDA Page

Effective Date: Apr 16, 2025
Approval ID: b4159c07-b114-4256-b9a9-e6af811704fa
Products: 1 registered
Version: 4

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, USP safely and effectively. See full prescribing information for GADOTERATE MEGLUMINE INJECTION, USP. Gadoterate Meglumine Injection, USP, for intravenous use PHARMACY BULK PACKAGE NOT FOR DIRECT INFUSION Initial U.S. Approval: 2013

Quick Stats

Total Products1

Labelers2

Label Sections18

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.