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PEG-3350, Electrolytes, and Ascorbate

These highlights do not include all the information needed to use POLYETHYLENE GLYCOL-3350, ELECTROLYTES, AND ASCORBATE FOR ORAL SOLUTION safely and effectively. See full prescribing information for POLYETHYLENE GLYCOL-3350, ELECTROLYTES, AND ASCORBATE FOR ORAL SOLUTION. POLYETHYLENE GLYCOL-3350, ELECTROLYTES, AND ASCORBATE FOR ORAL SOLUTION (polyethylene glycol 3350, sodium sulfate, sodium chloride, potassium chloride, sodium ascorbate, and ascorbic acid for oral solution)Initial U.S. Approval: 2006

Approved
Approval ID

cd9c0751-10fa-4f5f-bf29-742823541d22

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Jun 1, 2023

Manufacturers
FDA

Oceanside Pharmaceuticals

DUNS: 832011691

Products 1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

polyethylene glycol 3350, Sodium Sulfate, Sodium Chloride, Potassium Chloride, Sodium Ascorbate, and Ascorbic Acid

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code68682-201
Application NumberNDA021881
Product Classification
M
Marketing Category
C73594
G
Generic Name
polyethylene glycol 3350, Sodium Sulfate, Sodium Chloride, Potassium Chloride, Sodium Ascorbate, and Ascorbic Acid
Product Specifications
Effective DateJune 1, 2023
FDA Product Classification

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PEG-3350, Electrolytes, and Ascorbate - FDA Drug Approval Details