sapropterin dihydrochloride

🇺🇸 United States

FDA Page

Effective Date: Aug 6, 2026
Approval ID: c4d92cce-e899-4f14-b19c-5e17f9922215
Products: 0 registered
Version: 3

Regulatory Information

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Status

Approved

Full Title

These highlights do not include all the information needed to use SAPROPTERIN DIHYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for SAPROPTERIN DIHYDROCHLORIDE TABLETS. SAPROPTERIN DIHYDROCHLORIDE tablets, for oral useInitial U.S. Approval: 2007

Quick Stats

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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.