FDA.reportPublic FDA data

Application 017637

Type
NDA
Sponsor
ICU MEDICAL INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
002PHYSIOSOL IN PLASTIC CONTAINERMAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM ACETATE; SODIUM CHLORIDE; SODIUM GLUCONATESOLUTION;IRRIGATION30MG/100ML;37MG/100ML;222MG/100ML;526MG/100ML;502MG/100MLNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0409-6141PhysiosolSODIUM CHLORIDE, SODIUM ACETATE ANHYDROUS, SODIUM GLUCONATE, POTASSIUM CHLORIDE, and MAGNESIUM CHLORIDEHospira, Inc.NDACurrent
0990-6141PhysiosolSODIUM CHLORIDE, SODIUM ACETATE ANHYDROUS, SODIUM GLUCONATE, POTASSIUM CHLORIDE, and MAGNESIUM CHLORIDEICU Medical Inc.NDACurrent
0990-6141PhysiosolSODIUM CHLORIDE, SODIUM ACETATE ANHYDROUS, SODIUM GLUCONATE, POTASSIUM CHLORIDE, and MAGNESIUM CHLORIDEICU Medical Inc.NDACurrent
0990-6141PhysiosolSODIUM CHLORIDE, SODIUM ACETATE ANHYDROUS, SODIUM GLUCONATE, POTASSIUM CHLORIDE, and MAGNESIUM CHLORIDEICU Medical Inc.NDACurrent
0990-6141PhysiosolSODIUM CHLORIDE, SODIUM ACETATE ANHYDROUS, SODIUM GLUCONATE, POTASSIUM CHLORIDE, and MAGNESIUM CHLORIDEICU Medical Inc.NDACurrent