Optison

GE Healthcare Inc.🇺🇸 United States

FDA Page

Effective Date: Aug 25, 2025
Approval ID: 46bcf276-d423-408a-a410-f11383406a94
Products: 1 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 OPTISON safely and effectively. See full prescribing information for OPTISON. OPTISON (perflutren protein-type A microspheres) injectable suspension, for intravenous use Initial U.S. Approval: 1997

Quick Stats

Total Products1

Labelers2

Label Sections34

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.