ORFADIN

Swedish Orphan Biovitrum AB (publ)🇺🇸 United States

FDA Page

Effective Date: Jun 20, 2022
Approval ID: 00307f42-748d-4227-8c6f-ed5f0a89ae0a
Products: 1 registered
Version: 11

Regulatory Information

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Status

Approved

Full Title

These highlights do not include all the information needed to use ORFADIN safely and effectively. See full prescribing information for ORFADIN. ORFADIN (nitisinone) capsules, for oral use ORFADIN (nitisinone) oral suspension Initial U.S. Approval: 2002

Quick Stats

Total Products1

Labelers2

Label Sections19

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.