OMNISCAN

GE Healthcare Inc.🇺🇸 United States

FDA Page

Effective Date: Feb 6, 2024
Approval ID: 1e9a37e2-f28a-4373-bf0f-3e9b60f42d8a
Products: 2 registered
Version: 19

Regulatory Information

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Status

Approved

Full Title

These highlights do not include all the information needed to use OMNISCAN safely and effectively. See full prescribing information for OMNISCAN. OMNISCAN™ (gadodiamide) Injection for Intravenous Use Initial U.S. Approval: 1993

Quick Stats

Total Products2

Labelers2

Label Sections41

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.