FDA.reportPublic FDA data

Application 090231

Type
ANDA
Sponsor
NOVEL LABS INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001PEG 3350 AND ELECTROLYTESPOLYETHYLENE 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/BOTNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
40032-090POLYETHYLENE GLYCOL-3350 AND ELECTROLYTESPOLYETHYLENE GLYCOL-3350 AND ELECTROLYTESNovel Laboratories, Inc.ANDACurrent
43386-090GAVILYTE Gpolyethylene glycol-3350 and ElectrolytesLupin Pharmaceuticals,Inc.ANDACurrent
43386-090GaviLyte Gpolyethylene glycol-3350 and ElectrolytesLupin Pharmaceuticals,Inc.ANDACurrent
43386-090GAVILYTE Gpolyethylene glycol-3350 and ElectrolytesLupin Pharmaceuticals,Inc.ANDACurrent
43386-090GAVILYTE Gpolyethylene glycol-3350 and ElectrolytesLupin Pharmaceuticals,Inc.ANDACurrent
43386-090GaviLyte GPolyethylene Glycol-3350 and ElectrolytesGAVIS Pharmaceuticals, LLCANDACurrent