GAVILYTE-N

Lupin Pharmaceuticals,Inc.🇺🇸 United States

FDA Page

Effective Date: Sep 10, 2025
Approval ID: 27195187-75a3-431f-90d9-84da1b94e849
Products: 1 registered
Version: 6

Regulatory Information

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Status

Approved

Full Title

These highlights do not include all the information needed to use GaviLyte – N safely and effectively. See full prescribing information for GaviLyte – N GaviLyte™ – N (polyethylene glycol 3350 (420 g), sodium chloride, sodium bicarbonate and potassium chloride for oral solution)Initial U.S. Approval: 1991

Quick Stats

Total Products1

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.