Carglumic acid

Burel Pharmaceuticals, LLC🇺🇸 United States

FDA Page

Effective Date: Mar 19, 2024
Approval ID: 2aee4281-402b-4cd6-9e6a-08945262e1a1
Products: 1 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 CARGLUMIC ACID TABLETS FOR ORAL SUSPENSION safely and effectively. See full prescribing information for CARGLUMIC ACID TABLETS FOR ORAL SUSPENSION.CARGLUMIC ACID tablets for oral suspensionInitial U.S. Approval: 2010

Quick Stats

Total Products1

Labelers2

Label Sections29

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.