Mirabegron

Zydus Pharmaceuticals (USA) Inc.🇺🇸 United States

FDA Page

Effective Date: Feb 29, 2024
Approval ID: 2e40eb74-3b2a-47f7-bf31-fe27484f9bd2
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 MIRABEGRON EXTENDED-RELEASE TABLETS safely and effectively. See full prescribing information for MIRABEGRON EXTENDED-RELEASE TABLETS MIRABEGRON extended-release tablets, for oral useInitial U.S. Approval: 2012

Quick Stats

Total Products2

Labelers2

Label Sections36

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.