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Plenvu

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

Approved
Approval ID

79f930fa-5674-4f30-8ae8-9448d6243797

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Sep 1, 2023

Manufacturers
FDA

Salix Pharmaceuticals, Inc

DUNS: 793108036

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, ASCORBIC ACID, SODIUM ASCORBATE

PRODUCT DETAILS

NDC Product Code65649-400
Application NumberNDA209381
Marketing CategoryC73594
Route of AdministrationN/A
Effective DateSeptember 1, 2023
Generic NamePOLYETHYLENE GLYCOL 3350, SODIUM SULFATE, SODIUM CHLORIDE, POTASSIUM CHLORIDE, ASCORBIC ACID, SODIUM ASCORBATE

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Plenvu - FDA Drug Approval Details