PROCYSBI

Horizon Therapeutics USA, Inc.🇺🇸 United States

FDA Page

Effective Date: Jun 25, 2026
Approval ID: d3a3ec28-f746-463a-bb92-3bc8826db09e
Products: 4 registered
Version: 13

Regulatory Information

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Status

Approved

Full Title

These highlights do not include all the information needed to use PROCYSBI safely and effectively. See Full Prescribing Information for PROCYSBI. PROCYSBI (cysteamine bitartrate) delayed-release capsules, for oral use PROCYSBI (cysteamine bitartrate) delayed-release oral granules Initial U.S. Approval: 1994

Quick Stats

Total Products4

Labelers2

Label Sections23

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.