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
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code65649-400
Application NumberNDA209381
Product Classification
M
Marketing Category
C73594
G
Generic Name
POLYETHYLENE GLYCOL 3350, SODIUM SULFATE, SODIUM CHLORIDE, POTASSIUM CHLORIDE, ASCORBIC ACID, SODIUM ASCORBATE
Product Specifications
Effective DateSeptember 1, 2023
FDA Product Classification