Approvals/FDA/Polyethylene Glycol 3350, Sodium Chloride, Sodium Bicarbonate and Potassium Chloride - Unflavored

Approved

HUMAN PRESCRIPTION DRUG LABEL

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Polyethylene Glycol 3350, Sodium Chloride, Sodium Bicarbonate and Potassium Chloride - Unflavored

Strides Pharma Science Limited🇺🇸 United States

FDA Page

Effective Date: Sep 1, 2025
Approval ID: 37c111ec-5b62-42b9-bbb2-3b0c530e34c9
Products: 3 registered
Version: 8

Regulatory Information

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Status

Approved

Full Title

These highlights do not include all the information needed to use POLYETHYLENE GLYCOL 3350, SODIUM CHLORIDE, SODIUM BICARBONATE and POTASSIUM CHLORIDE for Oral Solution safely and effectively. See full prescribing information for POLYETHYLENE GLYCOL 3350, SODIUM CHLORIDE, SODIUM BICARBONATE and POTASSIUM CHLORIDE for Oral Solution. POLYETHYLENE GLYCOL 3350, SODIUM CHLORIDE, SODIUM BICARBONATE and POTASSIUM CHLORIDE for Oral Solution (UNFLAVORED, LEMON AND ORANGE FLAVORS) Initial U.S. Approval: 1991

Quick Stats

Total Products3

Labelers2

Label Sections21

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.