FDA.reportPublic FDA data

Application 019011

Type
NDA
Sponsor
BRAINTREE

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001GOLYTELYPOLYETHYLENE GLYCOL 3350; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE; SODIUM SULFATE ANHYDROUSFOR SOLUTION;ORAL236GM/BOT;2.97GM/BOT;6.74GM/BOT;5.86GM/BOT;22.74GM/BOTYesYes
002GOLYTELYPOLYETHYLENE GLYCOL 3350; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE; SODIUM SULFATE ANHYDROUSFOR SOLUTION;ORAL227.1GM/PACKET;2.82GM/PACKET;6.36GM/PACKET;5.53GM/PACKET;21.5GM/PACKETYesNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
10572-100PEG-3350 and ElectrolytesPolyethylene Glycol 3350, Sodium Sulfate Anhydrous, Sodium Bicarbonate, Sodium Chloride, Potassium ChlorideAffordable Pharmaceuticals, LLCNDA AUTHORIZED GENERICCurrent
10572-100PEG-3350 and ElectrolytesPolyethylene Glycol 3350, Sodium Sulfate Anhydrous, Sodium Bicarbonate, Sodium Chloride, Potassium ChlorideAffordable Pharmaceuticals, LLCNDA AUTHORIZED GENERICCurrent
10572-100PEG-3350 and ElectrolytesPolyethylene Glycol 3350, Sodium Sulfate Anhydrous, Sodium Bicarbonate, Sodium Chloride, Potassium ChlorideAffordable Pharmaceuticals, LLCNDA AUTHORIZED GENERICCurrent
10572-100PEG-3350 and ElectrolytesPolyethylene Glycol 3350, Sodium Sulfate Anhydrous, Sodium Bicarbonate, Sodium Chloride, Potassium ChlorideAffordable Pharmaceuticals, LLCNDA AUTHORIZED GENERICCurrent
10572-101PEG-3350 and ElectrolytesPolyethylene Glycol 3350, Sodium Sulfate Anhydrous, Sodium Bicarbonate, Sodium Chloride, Potassium ChlorideAffordable Pharmaceuticals, LLCNDA AUTHORIZED GENERICCurrent
10572-101PEG-3350 and ElectrolytesPolyethylene Glycol 3350, Sodium Sulfate Anhydrous, Sodium Bicarbonate, Sodium Chloride, Potassium ChlorideAffordable Pharmaceuticals, LLCNDA AUTHORIZED GENERICCurrent
10572-101PEG-3350 and ElectrolytesPolyethylene Glycol 3350, Sodium Sulfate Anhydrous, Sodium Bicarbonate, Sodium Chloride, Potassium ChlorideAffordable Pharmaceuticals, LLCNDA AUTHORIZED GENERICCurrent
10572-101PEG-3350 and ElectrolytesPolyethylene Glycol 3350, Sodium Sulfate Anhydrous, Sodium Bicarbonate, Sodium Chloride, Potassium ChlorideAffordable Pharmaceuticals, LLCNDA AUTHORIZED GENERICCurrent
52268-100GoLYTELYPolyethylene Glycol 3350, Sodium Sulfate Anhydrous, Sodium Bicarbonate, Sodium Chloride, Potassium ChlorideBraintree Laboratories, Inc.NDACurrent
52268-100GoLYTELYPolyethylene Glycol 3350, Sodium Sulfate Anhydrous, Sodium Bicarbonate, Sodium Chloride, Potassium ChlorideBraintree Laboratories, Inc.NDACurrent
52268-100GoLYTELYPolyethylene Glycol 3350, Sodium Sulfate Anhydrous, Sodium Bicarbonate, Sodium Chloride, Potassium ChlorideBraintree Laboratories, Inc.NDACurrent
52268-100GoLYTELYPolyethylene Glycol 3350, Sodium Sulfate Anhydrous, Sodium Bicarbonate, Sodium Chloride, Potassium ChlorideBraintree Laboratories, Inc.NDACurrent
52268-101GoLYTELYPolyethylene Glycol 3350, Sodium Sulfate Anhydrous, Sodium Bicarbonate, Sodium Chloride, Potassium ChlorideBraintree Laboratories, Inc.NDACurrent
52268-101GoLYTELYPolyethylene Glycol 3350, Sodium Sulfate Anhydrous, Sodium Bicarbonate, Sodium Chloride, Potassium ChlorideBraintree Laboratories, Inc.NDACurrent
52268-101GoLYTELYPolyethylene Glycol 3350, Sodium Sulfate Anhydrous, Sodium Bicarbonate, Sodium Chloride, Potassium ChlorideBraintree Laboratories, Inc.NDACurrent
52268-101GoLYTELYPolyethylene Glycol 3350, Sodium Sulfate Anhydrous, Sodium Bicarbonate, Sodium Chloride, Potassium ChlorideBraintree Laboratories, Inc.NDACurrent
52268-700GoLYTELYPolyethylene Glycol 3350, Sodium Sulfate Anhydrous, Sodium Bicarbonate, Sodium Chloride, Potassium ChlorideBraintree Laboratories, Inc.NDACurrent
52268-700GoLYTELYPolyethylene Glycol 3350, Sodium Sulfate Anhydrous, Sodium Bicarbonate, Sodium Chloride, Potassium ChlorideBraintree Laboratories, Inc.NDACurrent
52268-700GoLYTELYPolyethylene Glycol 3350, Sodium Sulfate Anhydrous, Sodium Bicarbonate, Sodium Chloride, Potassium ChlorideBraintree Laboratories, Inc.NDACurrent
52268-700GoLYTELYPolyethylene Glycol 3350, Sodium Sulfate Anhydrous, Sodium Bicarbonate, Sodium Chloride, Potassium ChlorideBraintree Laboratories, Inc.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
67522SUPPL2021-05-18
67521SUPPL2021-05-18
67493SUPPL2021-05-17
63577SUPPL2020-06-16
63450SUPPL2020-06-08
63449SUPPL2020-06-08
63447SUPPL2020-06-08
43617ORIG2013-10-03
16170SUPPL2013-09-24
33687SUPPL2013-09-23
16169SUPPL2002-09-19