Gallium Ga-68 PSMA-11

Ionetix Corporation🇺🇸 United States

FDA Page

Effective Date: May 14, 2026
Approval ID: 357655a4-b3ee-4ea1-a1ea-50d4686546bb
Products: 1 registered
Version: 2

Regulatory Information

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Status

Approved

Full Title

These highlights do not include all the information needed to use GALLIUM GA 68 GOZETOTIDE INJECTION safely and effectively. See full prescribing information for GALLIUM GA 68 GOZETOTIDE INJECTION. GALLIUM GA 68 GOZETOTIDE injection, for intravenous use Initial U.S. Approval: 2020 ( Gozetotide is also known as PSMA-11)

Quick Stats

Total Products1

Labelers1

Label Sections17

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.