FDA.reportPublic FDA data

Application 018371

Type
NDA
Sponsor
ICU MEDICAL INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001POTASSIUM CHLORIDE 20MEQ IN DEXTROSE 5% IN PLASTIC CONTAINERDEXTROSE; POTASSIUM CHLORIDEINJECTABLE;INJECTION5GM/100ML;149MG/100MLNoNo
002POTASSIUM CHLORIDE 40MEQ IN DEXTROSE 5% IN PLASTIC CONTAINERDEXTROSE; POTASSIUM CHLORIDEINJECTABLE;INJECTION5GM/100ML;298MG/100MLNoNo
003POTASSIUM CHLORIDE 30MEQ IN DEXTROSE 5% IN PLASTIC CONTAINERDEXTROSE; POTASSIUM CHLORIDEINJECTABLE;INJECTION5GM/100ML;224MG/100MLNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0409-7905Potassium Chloride in DextroseDEXTROSE MONOHYDRATE and POTASSIUM CHLORIDEHospira, Inc.NDACurrent
0409-7905Potassium Chloride in DextroseDEXTROSE MONOHYDRATE and POTASSIUM CHLORIDEHospira, Inc.NDACurrent
0409-7905Potassium Chloride in DextroseDEXTROSE MONOHYDRATE and POTASSIUM CHLORIDEHospira, Inc.NDACurrent
0409-7906Potassium Chloride in DextroseDEXTROSE MONOHYDRATE and POTASSIUM CHLORIDEHospira, Inc.NDACurrent
0409-7906Potassium Chloride in DextroseDEXTROSE MONOHYDRATE and POTASSIUM CHLORIDEHospira, Inc.NDACurrent
0409-7996Potassium Chloride in DextroseDEXTROSE MONOHYDRATE and POTASSIUM CHLORIDEHospira, Inc.NDACurrent
0409-7996Potassium Chloride in DextroseDEXTROSE MONOHYDRATE and POTASSIUM CHLORIDEHospira, Inc.NDACurrent
0990-7905Potassium Chloride in Dextrosedextrose monohydrate and potassium chloride injection, solutionICU Medical Inc.NDACurrent
0990-7905Potassium Chloride in Dextrosedextrose monohydrate and potassium chloride injection, solutionICU Medical Inc.NDACurrent
0990-7905Potassium Chloride in Dextrosedextrose monohydrate and potassium chloride injection, solutionICU Medical Inc.NDACurrent
0990-7905Potassium Chloride in Dextrosedextrose monohydrate and potassium chloride injection, solutionICU Medical Inc.NDACurrent