FDA.reportPublic FDA data

Application 018362

Type
NDA
Sponsor
ICU MEDICAL INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
002POTASSIUM CHLORIDE 30MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINERDEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDEINJECTABLE;INJECTION5GM/100ML;224MG/100ML;450MG/100MLYesYes
003POTASSIUM CHLORIDE 40MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINERDEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDEINJECTABLE;INJECTION5GM/100ML;298MG/100ML;450MG/100MLYesYes
004POTASSIUM CHLORIDE 5MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINERDEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDEINJECTABLE;INJECTION5GM/100ML;149MG/100ML;450MG/100MLYesNo
005POTASSIUM CHLORIDE 10MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINERDEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDEINJECTABLE;INJECTION5GM/100ML;149MG/100ML;450MG/100MLYesYes
006POTASSIUM CHLORIDE 15MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINERDEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDEINJECTABLE;INJECTION5GM/100ML;224MG/100ML;450MG/100MLYesNo
007POTASSIUM CHLORIDE 20MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINERDEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDEINJECTABLE;INJECTION5GM/100ML;298MG/100ML;450MG/100MLYesNo
008POTASSIUM CHLORIDE 5MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINERDEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDEINJECTABLE;INJECTION5GM/100ML;74.5MG/100ML;450MG/100MLYesNo
009POTASSIUM CHLORIDE 10MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINERDEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDEINJECTABLE;INJECTION5GM/100ML;74.5MG/100ML;450MG/100MLYesYes
010POTASSIUM CHLORIDE 20MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINERDEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDEINJECTABLE;INJECTION5GM/100ML;149MG/100ML;450MG/100MLYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0409-7902Potassium Chloride in Dextrose and Sodium ChlorideDEXTROSE MONOHYDRATE, SODIUM CHLORIDE, and POTASSIUM CHLORIDEHospira, Inc.NDACurrent
0409-7902Potassium Chloride in Dextrose and Sodium ChlorideDEXTROSE MONOHYDRATE, SODIUM CHLORIDE, and POTASSIUM CHLORIDEHospira, Inc.NDACurrent
0409-7902Potassium Chloride in Dextrose and Sodium ChlorideDEXTROSE MONOHYDRATE, SODIUM CHLORIDE, and POTASSIUM CHLORIDEHospira, Inc.NDACurrent
0409-7903Potassium Chloride in Dextrose and Sodium ChlorideDEXTROSE MONOHYDRATE, SODIUM CHLORIDE, and POTASSIUM CHLORIDEHospira, Inc.NDACurrent
0409-7903Potassium Chloride in Dextrose and Sodium ChlorideDEXTROSE MONOHYDRATE, SODIUM CHLORIDE, and POTASSIUM CHLORIDEHospira, Inc.NDACurrent
0409-7903Potassium Chloride in Dextrose and Sodium ChlorideDEXTROSE MONOHYDRATE, SODIUM CHLORIDE, and POTASSIUM CHLORIDEHospira, Inc.NDACurrent
0409-7904Potassium Chloride in Dextrose and Sodium ChlorideDEXTROSE MONOHYDRATE, SODIUM CHLORIDE, and POTASSIUM CHLORIDEHospira, Inc.NDACurrent
0409-7904Potassium Chloride in Dextrose and Sodium ChlorideDEXTROSE MONOHYDRATE, SODIUM CHLORIDE, and POTASSIUM CHLORIDEHospira, Inc.NDACurrent
0409-7904Potassium Chloride in Dextrose and Sodium ChlorideDEXTROSE MONOHYDRATE, SODIUM CHLORIDE, and POTASSIUM CHLORIDEHospira, Inc.NDACurrent
0409-7993Potassium Chloride in Dextrose and Sodium ChlorideDEXTROSE MONOHYDRATE, SODIUM CHLORIDE, and POTASSIUM CHLORIDEHospira, Inc.NDACurrent
0409-7993Potassium Chloride in Dextrose and Sodium ChlorideDEXTROSE MONOHYDRATE, SODIUM CHLORIDE, and POTASSIUM CHLORIDEHospira, Inc.NDACurrent
0409-7993Potassium Chloride in Dextrose and Sodium ChlorideDEXTROSE MONOHYDRATE, SODIUM CHLORIDE, and POTASSIUM CHLORIDEHospira, Inc.NDACurrent
0990-7902Potassium Chloride in Dextrose and Sodium ChlorideDEXTROSE MONOHYDRATE, SODIUM CHLORIDE, and POTASSIUM CHLORIDEICU Medical Inc.NDACurrent
0990-7902Potassium Chloride in Dextrose and Sodium ChlorideDEXTROSE MONOHYDRATE, SODIUM CHLORIDE, and POTASSIUM CHLORIDEICU Medical Inc.NDACurrent
0990-7902Potassium Chloride in Dextrose and Sodium ChlorideDEXTROSE MONOHYDRATE, SODIUM CHLORIDE, and POTASSIUM CHLORIDEICU Medical Inc.NDACurrent
0990-7902Potassium Chloride in Dextrose and Sodium ChlorideDEXTROSE MONOHYDRATE, SODIUM CHLORIDE, and POTASSIUM CHLORIDEICU Medical Inc.NDACurrent
0990-7902Potassium Chloride in Dextrose and Sodium ChlorideDEXTROSE MONOHYDRATE, SODIUM CHLORIDE, and POTASSIUM CHLORIDEICU Medical Inc.NDACurrent
0990-7902Potassium Chloride in Dextrose and Sodium ChlorideDEXTROSE MONOHYDRATE, SODIUM CHLORIDE, and POTASSIUM CHLORIDEICU Medical Inc.NDACurrent
0990-7902Potassium Chloride in Dextrose and Sodium ChlorideDEXTROSE MONOHYDRATE, SODIUM CHLORIDE, and POTASSIUM CHLORIDEICU Medical Inc.NDACurrent
0990-7903Potassium Chloride in Dextrose and Sodium ChlorideDEXTROSE MONOHYDRATE, SODIUM CHLORIDE, and POTASSIUM CHLORIDEICU Medical Inc.NDACurrent
0990-7903Potassium Chloride in Dextrose and Sodium ChlorideDEXTROSE MONOHYDRATE, SODIUM CHLORIDE, and POTASSIUM CHLORIDEICU Medical Inc.NDACurrent
0990-7903Potassium Chloride in Dextrose and Sodium ChlorideDEXTROSE MONOHYDRATE, SODIUM CHLORIDE, and POTASSIUM CHLORIDEICU Medical Inc.NDACurrent
0990-7903Potassium Chloride in Dextrose and Sodium ChlorideDEXTROSE MONOHYDRATE, SODIUM CHLORIDE, and POTASSIUM CHLORIDEICU Medical Inc.NDACurrent
0990-7903Potassium Chloride in Dextrose and Sodium ChlorideDEXTROSE MONOHYDRATE, SODIUM CHLORIDE, and POTASSIUM CHLORIDEICU Medical Inc.NDACurrent
0990-7903Potassium Chloride in Dextrose and Sodium ChlorideDEXTROSE MONOHYDRATE, SODIUM CHLORIDE, and POTASSIUM CHLORIDEICU Medical Inc.NDACurrent
0990-7903Potassium Chloride in Dextrose and Sodium ChlorideDEXTROSE MONOHYDRATE, SODIUM CHLORIDE, and POTASSIUM CHLORIDEICU Medical Inc.NDACurrent
0990-7904Potassium Chloride in Dextrose and Sodium ChlorideDEXTROSE MONOHYDRATE, SODIUM CHLORIDE, and POTASSIUM CHLORIDEICU Medical Inc.NDACurrent
0990-7904Potassium Chloride in Dextrose and Sodium ChlorideDEXTROSE MONOHYDRATE, SODIUM CHLORIDE, and POTASSIUM CHLORIDEICU Medical Inc.NDACurrent
0990-7904Potassium Chloride in Dextrose and Sodium ChlorideDEXTROSE MONOHYDRATE, SODIUM CHLORIDE, and POTASSIUM CHLORIDEICU Medical Inc.NDACurrent
0990-7904Potassium Chloride in Dextrose and Sodium ChlorideDEXTROSE MONOHYDRATE, SODIUM CHLORIDE, and POTASSIUM CHLORIDEICU Medical Inc.NDACurrent
0990-7904Potassium Chloride in Dextrose and Sodium ChlorideDEXTROSE MONOHYDRATE, SODIUM CHLORIDE, and POTASSIUM CHLORIDEICU Medical Inc.NDACurrent
0990-7904Potassium Chloride in Dextrose and Sodium ChlorideDEXTROSE MONOHYDRATE, SODIUM CHLORIDE, and POTASSIUM CHLORIDEICU Medical Inc.NDACurrent
0990-7904Potassium Chloride in Dextrose and Sodium ChlorideDEXTROSE MONOHYDRATE, SODIUM CHLORIDE, and POTASSIUM CHLORIDEICU Medical Inc.NDACurrent
0990-7993Potassium Chloride in Dextrose and Sodium ChlorideDEXTROSE MONOHYDRATE, SODIUM CHLORIDE, and POTASSIUM CHLORIDEICU Medical Inc.NDACurrent
0990-7993Potassium Chloride in Dextrose and Sodium ChlorideDEXTROSE MONOHYDRATE, SODIUM CHLORIDE, and POTASSIUM CHLORIDEICU Medical Inc.NDACurrent
0990-7993Potassium Chloride in Dextrose and Sodium ChlorideDEXTROSE MONOHYDRATE, SODIUM CHLORIDE, and POTASSIUM CHLORIDEICU Medical Inc.NDACurrent
0990-7993Potassium Chloride in Dextrose and Sodium ChlorideDEXTROSE MONOHYDRATE, SODIUM CHLORIDE, and POTASSIUM CHLORIDEICU Medical Inc.NDACurrent
0990-7993Potassium Chloride in Dextrose and Sodium ChlorideDEXTROSE MONOHYDRATE, SODIUM CHLORIDE, and POTASSIUM CHLORIDEICU Medical Inc.NDACurrent
0990-7993Potassium Chloride in Dextrose and Sodium ChlorideDEXTROSE MONOHYDRATE, SODIUM CHLORIDE, and POTASSIUM CHLORIDEICU Medical Inc.NDACurrent
0990-7993Potassium Chloride in Dextrose and Sodium ChlorideDEXTROSE MONOHYDRATE, SODIUM CHLORIDE, and POTASSIUM CHLORIDEICU Medical Inc.NDACurrent