What is PEG-LYTE used for?

PEG-LYTE is an FDA-approved medication. See full prescribing information for approved uses.

Is PEG-LYTE FDA approved?

Yes, PEG-LYTE is FDA approved and manufactured by Novartis.

PEG-LYTE is manufactured by Novartis.

Data updated: Mar 29, 2026

PEG-LYTE

POLYETHYLENE GLYCOL 3350

Jump to: Indications Approvals Trials Competitors Safety Patents

Details

Status: Discontinued
First Approved: N/A
Routes: ORAL
Dosage Forms: FOR SUSPENSION

Companies

Novartis

Active Ingredient: POLYETHYLENE GLYCOL 3350 , POTASSIUM CHLORIDE , SODIUM BICARBONATE , SODIUM CHLORIDE , SODIUM SULFATE ANHYDROUS

PEG-LYTE Approval History

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Active Pipeline

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Ongoing clinical trials by development phase

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Key Completed Trials

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Completed studies with published results, ranked by significance

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Trial Timeline

ClinicalTrials.gov ↗ Pro

Full development history with FDA approval milestones

| Show all trials (incl. adjuvant)

Understanding FDA Approval Types

Count	Type	What it means
-	ORIG	Original approval - drug first enters market
-	SUPPL - Efficacy	New indication (new disease/condition approved)
-	SUPPL - Labeling	Label text changes (warnings, dosing updates)
-	SUPPL - Manufacturing	Production changes (new facility)
-	SUPPL - Chemistry	Formulation changes (new dosage strength)

Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.

PEG-LYTE FDA Label Details

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Data Sources

FDA Approval: ANDA073098 → Trials: ClinicalTrials.gov →

Data sourced from official FDA and NIH databases. Click links to verify on original sources.

PEG-LYTE

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