Kyzatrex

Marius Pharmaceuticals🇺🇸 United States

FDA Page

Effective Date: Aug 26, 2026
Approval ID: 7f7167a7-2a25-47e2-acf5-33f499fce971
Products: 3 registered
Version: 23

Regulatory Information

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Status

Approved

Full Title

These highlights do not include all the information needed to use KYZATREX® safely and effectively. See full prescribing information for KYZATREX®. KYZATREX® (testosterone undecanoate) capsules, for oral use, CIII Initial U.S. approval: 1953

Quick Stats

Total Products3

Labelers2

Label Sections35

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.