FDA.reportPublic FDA data

Application 017609

Type
NDA
Sponsor
ICU MEDICAL INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001NORMOSOL-R AND DEXTROSE 5% IN PLASTIC CONTAINERDEXTROSE; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM ACETATE; SODIUM CHLORIDE; SODIUM GLUCONATEINJECTABLE;INJECTION5GM/100ML;30MG/100ML;37MG/100ML;222MG/100ML;526MG/100ML;502MG/100MLNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0409-7968Normosol-R and DextroseDextrose, Sodium Chloride, Sodium Acetate Anhydrous, Sodium Gluconate, Potassium Chloride, and Magnesium ChlorideHospira, Inc.NDACurrent
0409-7968Normosol-R and DextroseDextrose, Sodium Chloride, Sodium Acetate Anhydrous, Sodium Gluconate, Potassium Chloride, and Magnesium ChlorideHospira, Inc.NDACurrent
0990-7968Normosol-R and DextroseDextrose, Sodium Chloride, Sodium Acetate Anhydrous, Sodium Gluconate, Potassium Chloride, and Magnesium ChlorideICU Medical Inc.NDACurrent
0990-7968Normosol-R and DextroseDextrose, Sodium Chloride, Sodium Acetate Anhydrous, Sodium Gluconate, Potassium Chloride, and Magnesium ChlorideICU Medical Inc.NDACurrent
0990-7968Normosol-R and DextroseDextrose, Sodium Chloride, Sodium Acetate Anhydrous, Sodium Gluconate, Potassium Chloride, and Magnesium ChlorideICU Medical Inc.NDACurrent
0990-7968Normosol-R and DextroseDextrose, Sodium Chloride, Sodium Acetate Anhydrous, Sodium Gluconate, Potassium Chloride, and Magnesium ChlorideICU Medical Inc.NDACurrent
0990-7968Normosol-R and DextroseDextrose, Sodium Chloride, Sodium Acetate Anhydrous, Sodium Gluconate, Potassium Chloride, and Magnesium ChlorideICU Medical Inc.NDACurrent