Data updated: Mar 10, 2026

PEG-3350, SODIUM SULFATE, SODIUM CHLORIDE, POTASSIUM CHLORIDE, SODIUM ASCORBATE AND ASCORBIC ACID

Q: Is PEG-3350, SODIUM SULFATE, SODIUM CHLORIDE, POTASSIUM CHLORIDE, SODIUM ASCORBATE AND ASCORBIC ACID FDA approved?

Yes, PEG-3350, SODIUM SULFATE, SODIUM CHLORIDE, POTASSIUM CHLORIDE, SODIUM ASCORBATE AND ASCORBIC ACID is FDA approved (first approved 2012-01-25) and manufactured by TARO.

ASCORBIC ACID

Approved 2012-01-25

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Indications

Phase 3 Trials

Years on Market

Details

Status: Discontinued
First Approved: 2012-01-25
Routes: ORAL
Dosage Forms: FOR SOLUTION

Companies

TARO NOVEL LABS INC

Active Ingredient: ASCORBIC ACID , POLYETHYLENE GLYCOL 3350 , POTASSIUM CHLORIDE , SODIUM ASCORBATE , SODIUM CHLORIDE , SODIUM SULFATE

PEG-3350, SODIUM SULFATE, SODIUM CHLORIDE, POTASSIUM CHLORIDE, SODIUM ASCORBATE AND ASCORBIC ACID Approval History

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What PEG-3350, SODIUM SULFATE, SODIUM CHLORIDE, POTASSIUM CHLORIDE, SODIUM ASCORBATE AND ASCORBIC ACID Treats

2 FDA approvals

Originally approved for its first indication in 2012 . Covers 2 distinct patient populations.

Other (2)

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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

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-3350, SODIUM SULFATE, SODIUM CHLORIDE, POTASSIUM CHLORIDE, SODIUM ASCORBATE AND ASCORBIC ACID FDA Label Details

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Data Sources

FDA Approval: ANDA207498 → Trials: ClinicalTrials.gov →

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