FDA.reportPublic FDA data

Application 019686

Type
NDA
Sponsor
ICU MEDICAL INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001POTASSIUM CHLORIDE 20MEQ IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINERPOTASSIUM CHLORIDE; SODIUM CHLORIDEINJECTABLE;INJECTION149MG/100ML;900MG/100MLNoNo
002POTASSIUM CHLORIDE 40MEQ IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINERPOTASSIUM CHLORIDE; SODIUM CHLORIDEINJECTABLE;INJECTION298MG/100ML;900MG/100MLNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0409-7115Potassium Chloride in Sodium ChlorideSODIUM CHLORIDE and POTASSIUM CHLORIDEHospira, Inc.NDACurrent
0409-7115Potassium Chloride in Sodium ChlorideSODIUM CHLORIDE and POTASSIUM CHLORIDEHospira, Inc.NDACurrent
0409-7115Potassium Chloride in Sodium ChlorideSODIUM CHLORIDE and POTASSIUM CHLORIDEHospira, Inc.NDACurrent
0409-7116Potassium Chloride in Sodium ChlorideSODIUM CHLORIDE and POTASSIUM CHLORIDEHospira, Inc.NDACurrent
0409-7116Potassium Chloride in Sodium ChlorideSODIUM CHLORIDE and POTASSIUM CHLORIDEHospira, Inc.NDACurrent
0409-7116Potassium Chloride in Sodium ChlorideSODIUM CHLORIDE and POTASSIUM CHLORIDEHospira, Inc.NDACurrent
0990-7115Potassium Chloride in Sodium ChlorideSODIUM CHLORIDE and POTASSIUM CHLORIDEICU Medical Inc.NDACurrent
0990-7115Potassium Chloride in Sodium ChlorideSODIUM CHLORIDE and POTASSIUM CHLORIDEICU Medical Inc.NDACurrent
0990-7115Potassium Chloride in Sodium ChlorideSODIUM CHLORIDE and POTASSIUM CHLORIDEICU Medical Inc.NDACurrent
0990-7115Potassium Chloride in Sodium ChlorideSODIUM CHLORIDE and POTASSIUM CHLORIDEICU Medical Inc.NDACurrent
0990-7115Potassium Chloride in Sodium ChlorideSODIUM CHLORIDE and POTASSIUM CHLORIDEICU Medical Inc.NDACurrent
0990-7116Potassium Chloride in Sodium ChlorideSODIUM CHLORIDE and POTASSIUM CHLORIDEICU Medical Inc.NDACurrent
0990-7116Potassium Chloride in Sodium ChlorideSODIUM CHLORIDE and POTASSIUM CHLORIDEICU Medical Inc.NDACurrent
0990-7116Potassium Chloride in Sodium ChlorideSODIUM CHLORIDE and POTASSIUM CHLORIDEICU Medical Inc.NDACurrent
0990-7116Potassium Chloride in Sodium ChlorideSODIUM CHLORIDE and POTASSIUM CHLORIDEICU Medical Inc.NDACurrent
0990-7116Potassium Chloride in Sodium ChlorideSODIUM CHLORIDE and POTASSIUM CHLORIDEICU Medical Inc.NDACurrent