GaviLyte-H and Bisacodyl

Lupin Pharmaceuticals, Inc.🇺🇸 United States

FDA Page

Effective Date: Jan 28, 2020
Approval ID: 78fe1c29-e22a-4615-a2f9-a61cd4eb38a3
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 GaviLyte-H and Bisacodyl safely and effectively. See full prescribing information for GaviLyte-H and Bisacodyl. GaviLyte-H and Bisacodyl (Polyethylene Glycol 3350, Sodium Chloride, Sodium Bicarbonate, Potassium Chloride and Bisacodyl Delayed release Tablet) KIT for ORAL use. Initial U.S. Approval: 2004

Quick Stats

Total Products1

Labelers2

Label Sections17

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.