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PEG-3350, sodium chloride, sodium bicarbonate and potassium chloride

These highlights do not include all the information needed to use PEG-3350, sodium chloride, sodium bicarbonate and potassium chloride for oral solution safely and effectively. See full prescribing information for PEG-3350, sodium chloride, sodium bicarbonate and potassium chloride for oral solution. Polyethylene glycol 3350, sodium chloride, sodium bicarbonate and potassium chloride for oral solution Initial U.S. Approval: 1991

Approved
Approval ID

89ca6d56-527a-4be2-baea-531156f0a7be

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

May 3, 2021

Manufacturers
FDA

Affordable Pharmaceuticals, LLC

DUNS: 182815311

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 chloride, sodium bicarbonate, potassium chloride

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code10572-302
Application NumberNDA019797
Product Classification
M
Marketing Category
C73605
G
Generic Name
polyethylene glycol 3350, sodium chloride, sodium bicarbonate, potassium chloride
Product Specifications
Route of AdministrationORAL
Effective DateMay 3, 2021
FDA Product Classification

INGREDIENTS (4)

POLYETHYLENE GLYCOL 3350Active
Quantity: 420 g in 4 L
Code: G2M7P15E5P
Classification: ACTIB
SODIUM BICARBONATEActive
Quantity: 5.72 g in 4 L
Code: 8MDF5V39QO
Classification: ACTIB
SODIUM CHLORIDEActive
Quantity: 11.2 g in 4 L
Code: 451W47IQ8X
Classification: ACTIB
POTASSIUM CHLORIDEActive
Quantity: 1.48 g in 4 L
Code: 660YQ98I10
Classification: ACTIB

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PEG-3350, sodium chloride, sodium bicarbonate and potassium chloride - FDA Drug Approval Details