Sapropterin dihydrochloride

NorthStar RxLLC🇺🇸 United States

FDA Page

Effective Date: Dec 4, 2023
Approval ID: b3999f74-920d-4444-afa7-f4211e4eb431
Products: 2 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 SAPROPTERIN DIHYDROCHLORIDE POWDER FOR ORAL SOLUTION safely and effectively. See full prescribing information for SAPROPTERIN DIHYDROCHLORIDE POWDER FOR ORAL SOLUTION. SAPROPTERIN DIHYDROCHLORIDE powder for oral solution Initial U.S. Approval: 2007

Quick Stats

Total Products2

Labelers2

Label Sections18

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.