azithromycin monohydrate

LUPIN LIMITED🇺🇸 United States

FDA Page

Effective Date: Feb 18, 2016
Approval ID: 782fc23e-1df2-4a84-98a2-36eb81268f92
Products: 1 registered
Version: 1

Regulatory Information

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Status

Approved

Full Title

These highlights do not include all the information needed to use azithromycin tablets safely and effectively. See full prescribing information for azithromycin tablets. AZITHROMYCIN tablets USP, 250 mg and 500 mg, for oral use Initial U.S. Approval: 1991.

Quick Stats

Total Products1

Labelers2

Label Sections18

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.