KOMBIGLYZE

AstraZeneca Pharmaceuticals LP🇺🇸 United States

FDA Page

Effective Date: Oct 24, 2019
Approval ID: fbd25da4-ebe6-45c9-beb8-93523d11a0b4
Products: 3 registered
Version: 21

Regulatory Information

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Status

Approved

Full Title

These highlights do not include all the information needed to use KOMBIGLYZE XR safely and effectively. See full prescribing information for KOMBIGLYZE XR. KOMBIGLYZE XR (saxagliptin and metformin hydrochloride extended-release) tablets, for oral useInitial U.S. Approval: 2010

Quick Stats

Total Products3

Labelers2

Label Sections20

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.