FDA.reportPublic FDA data

Application 018379

Type
NDA
Sponsor
FRESENIUS MEDCL

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001DELFLEX W/ DEXTROSE 4.25% IN PLASTIC CONTAINERCALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATESOLUTION;INTRAPERITONEAL25.7MG/100ML;4.25GM/100ML;15.2MG/100ML;567MG/100ML;392MG/100MLNoNo
002DELFLEX W/ DEXTROSE 1.5% IN PLASTIC CONTAINERCALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATESOLUTION;INTRAPERITONEAL25.7MG/100ML;1.5GM/100ML;15.2MG/100ML;567MG/100ML;392MG/100MLNoNo
003DELFLEX W/ DEXTROSE 2.5% IN PLASTIC CONTAINERCALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATESOLUTION;INTRAPERITONEAL25.7MG/100ML;2.5GM/100ML;15.2MG/100ML;567MG/100ML;392MG/100MLNoNo
004DELFLEX-LM W/ DEXTROSE 1.5% IN PLASTIC CONTAINERCALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATESOLUTION;INTRAPERITONEAL25.7MG/100ML;1.5GM/100ML;5.08MG/100ML;538MG/100ML;448MG/100MLNoNo
005DELFLEX-LM W/ DEXTROSE 2.5% IN PLASTIC CONTAINERCALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATESOLUTION;INTRAPERITONEAL25.7MG/100ML;2.5GM/100ML;5.08MG/100ML;538MG/100ML;448MG/100MLNoNo
006DELFLEX-LM W/ DEXTROSE 4.25% IN PLASTIC CONTAINERCALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATESOLUTION;INTRAPERITONEAL25.7MG/100ML;4.25GM/100ML;5.08MG/100ML;538MG/100ML;448MG/100MLNoNo
007DELFLEX W/ DEXTROSE 3.5% IN PLASTIC CONTAINERCALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATESOLUTION;INTRAPERITONEAL25.7MG/100ML;3.5GM/100ML;15.2MG/100ML;567MG/100ML;392MG/100MLNoNo
008DELFLEX-LM W/ DEXTROSE 3.5% IN PLASTIC CONTAINERCALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATESOLUTION;INTRAPERITONEAL25.7MG/100ML;3.5GM/100ML;5.08MG/100ML;538MG/100ML;448MG/100MLNoNo