XIGDUO

AstraZeneca Pharmaceuticals LP🇺🇸 United States

FDA Page

Effective Date: Aug 11, 2026
Approval ID: ac8a0f7b-9f69-4495-abbc-3a47cd75a859
Products: 5 registered
Version: 40

Regulatory Information

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Status

Approved

Full Title

These highlights do not include all the information needed to use XIGDUO XR safely and effectively. See full prescribing information for XIGDUO XR.XIGDUOXR (dapagliflozin and metformin hydrochloride extended-release) tablets, for oral useInitial U.S. Approval: 2014

Quick Stats

Total Products5

Labelers2

Label Sections39

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.