Mirabegron

Amneal Pharmaceuticals NY LLC🇺🇸 United States

FDA Page

Effective Date: Mar 26, 2026
Approval ID: e597023d-6dcc-4d9e-8ce0-2d28a5d862f3
Products: 0 registered
Version: 4

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 use Initial U.S. Approval: 2012

Quick Stats

Total Products0

Labelers1

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.