Mesalamine

Amneal Pharmaceuticals LLC🇺🇸 United States

FDA Page

Effective Date: May 23, 2024
Approval ID: 00f77203-3615-47e8-ae25-6e1cf8a2a00a
Products: 1 registered
Version: 10

Regulatory Information

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Status

Approved

Full Title

These highlights do not include all the information needed to use MESALAMINE DELAYED-RELEASE TABLETS safely and effectively. See full prescribing information for MESALAMINE DELAYED-RELEASE TABLETS. MESALAMINE delayed-release tablets, for oral use Initial U.S. Approval: 1987

Quick Stats

Total Products1

Labelers1

Label Sections16

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.