ONGENTYS

Neurocrine Biosciences, Inc.🇺🇸 United States

FDA Page

Effective Date: Apr 26, 2020
Approval ID: 278a60c4-2353-4657-b486-f392b93181b7
Products: 2 registered
Version: 5

Regulatory Information

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Status

Approved

Full Title

These highlights do not include all the information needed to use ONGENTYS ® safely and effectively. See full prescribing information for ONGENTYS ® . ONGENTYS ( opicapone ) capsules, for oral use Initial U.S. Approval: 20 20

Quick Stats

Total Products2

Labelers2

Label Sections26

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.