Tarpeyo(These highlights do not include all the information needed to use TARPEYO safely and effectively. See full prescribing information for TARPEYO. TARPEYO (budesonide) delayed release capsules, for oral useInitial U.S. Approval: 1997)

Calliditas Therapeutics AB🇺🇸 United States

FDA Page

Effective Date: Dec 31, 2023
Approval ID: 938cada4-d6bf-4252-836f-dd40f9eadb4d
Products: 1 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 TARPEYO safely and effectively. See full prescribing information for TARPEYO. TARPEYO (budesonide) delayed release capsules, for oral useInitial U.S. Approval: 1997

Quick Stats

Total Products1

Labelers2

Label Sections17

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.