FDA.reportPublic FDA data

Application 019395

Type
NDA
Sponsor
FRESENIUS MEDCL

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001INPERSOL-ZM W/ DEXTROSE 1.5% IN PLASTIC CONTAINERCALCIUM CHLORIDE; DEXTROSE; SODIUM CHLORIDE; SODIUM LACTATESOLUTION;INTRAPERITONEAL25.7MG/100ML;1.5GM/100ML;538MG/100ML;448MG/100MLNoNo
002INPERSOL-ZM W/ DEXTROSE 2.5% IN PLASTIC CONTAINERCALCIUM CHLORIDE; DEXTROSE; SODIUM CHLORIDE; SODIUM LACTATESOLUTION;INTRAPERITONEAL25.7MG/100ML;2.5GM/100ML;538MG/100ML;448MG/100MLNoNo
003INPERSOL-ZM W/ DEXTROSE 4.25% IN PLASTIC CONTAINERCALCIUM CHLORIDE; DEXTROSE; SODIUM CHLORIDE; SODIUM LACTATESOLUTION;INTRAPERITONEAL25.7MG/100ML;4.25GM/100ML;538MG/100ML;448MG/100MLNoNo