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FDA Approval

PEG-3350 and Electrolytes

FDA-approved pharmaceutical product with comprehensive regulatory information, manufacturing details, and complete labeling documentation.

FDA Approval Summary

Company
A-S Medication Solutions
DUNS: 830016429
Effective Date
June 20, 2023
Labeling Type
HUMAN PRESCRIPTION DRUG LABEL
Polyethylene glycol(236 g in 4 L)
Sodium sulfate(22.74 g in 4 L)
Sodium bicarbonate(6.74 g in 4 L)
Sodium chloride(5.86 g in 4 L)
Potassium chloride(2.97 g in 4 L)

Manufacturing Establishments1

FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.

A-S Medication Solutions

A-S Medication Solutions

830016429

Products1

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

PEG-3350 and Electrolytes

Product Details

NDC Product Code
50090-6521
Application Number
NDA019011
Marketing Category
NDA authorized generic (C73605)
Route of Administration
ORAL
Effective Date
September 28, 2022
Polyethylene glycolActive
Code: G2M7P15E5PClass: ACTIBQuantity: 236 g in 4 L
Sodium sulfateActive
Code: 36KCS0R750Class: ACTIBQuantity: 22.74 g in 4 L
Sodium bicarbonateActive
Code: 8MDF5V39QOClass: ACTIBQuantity: 6.74 g in 4 L
Sodium chlorideActive
Code: 451W47IQ8XClass: ACTIBQuantity: 5.86 g in 4 L
Potassium chlorideActive
Code: 660YQ98I10Class: ACTIBQuantity: 2.97 g in 4 L
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