FDA.reportPublic FDA data

Application 209381

Type
NDA
Sponsor
SALIX

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001PLENVUASCORBIC ACID; POLYETHYLENE GLYCOL 3350; POTASSIUM CHLORIDE; SODIUM ASCORBATE; SODIUM CHLORIDE; SODIUM SULFATEFOR SOLUTION;ORAL7.54GM;140GM;2.2GM;48.11GM;5.2GM;9GMYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
65649-400PlenvuPOLYETHYLENE GLYCOL 3350, SODIUM SULFATE, SODIUM CHLORIDE, POTASSIUM CHLORIDE, ASCORBIC ACID, SODIUMSalix Pharmaceuticals, InNDACurrent
65649-400PlenvuPOLYETHYLENE GLYCOL 3350, SODIUM SULFATE, SODIUM CHLORIDE, POTASSIUM CHLORIDE, ASCORBIC ACID, SODIUM ASCORBATESalix Pharmaceuticals, IncNDACurrent
65649-400PlenvuPOLYETHYLENE GLYCOL 3350, SODIUM SULFATE, SODIUM CHLORIDE, POTASSIUM CHLORIDE, ASCORBIC ACID, SODIUM ASCORBATESalix Pharmaceuticals, IncNDACurrent
65649-400PlenvuPOLYETHYLENE GLYCOL 3350, SODIUM SULFATE, SODIUM CHLORIDE, POTASSIUM CHLORIDE, ASCORBIC ACID, SODIUM ASCORBATESalix Pharmaceuticals, IncNDACurrent
65649-400PlenvuPOLYETHYLENE GLYCOL 3350, SODIUM SULFATE, SODIUM CHLORIDE, POTASSIUM CHLORIDE, ASCORBIC ACID, SODIUM ASCORBATESalix Pharmaceuticals, IncNDACurrent
65649-400PlenvuPOLYETHYLENE GLYCOL 3350, SODIUM SULFATE, SODIUM CHLORIDE, POTASSIUM CHLORIDE, ASCORBIC ACID, SODIUM ASCORBATESalix Pharmaceuticals, IncNDACurrent
65649-400PlenvuPOLYETHYLENE GLYCOL 3350, SODIUM SULFATE, SODIUM CHLORIDE, POTASSIUM CHLORIDE, ASCORBIC ACID, SODIUM ASCORBATESalix Pharmaceuticals, IncNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
75446SUPPL 2023-09-13
75445SUPPL 2023-09-13
75387SUPPL 2023-09-11
67528SUPPL2021-05-18
67527SUPPL2021-05-18
67513SUPPL2021-05-18
58938SUPPL2019-06-04
58885SUPPL2019-05-30
58884SUPPL2019-05-30
58237SUPPL2019-04-05
58234SUPPL2019-04-05
58227SUPPL2019-04-05
56556ORIG2018-11-26
54047ORIG2018-05-08
54033ORIG2018-05-07
54032ORIG2018-05-07