FDA.reportPublic FDA data

Application 078446

Type
ANDA
Sponsor
ICU MEDICAL INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001POTASSIUM CHLORIDE 0.149% IN SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINERPOTASSIUM CHLORIDE; SODIUM CHLORIDEINJECTABLE;INJECTION149MG/100ML;450MG/100MLNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0409-9257Potassium Chloride in Sodium ChlorideSODIUM CHLORIDE and POTASSIUM CHLORIDEHospira, Inc.ANDACurrent
0409-9257Potassium Chloride in Sodium ChlorideSODIUM CHLORIDE and POTASSIUM CHLORIDEHospira, Inc.ANDACurrent
0409-9257Potassium Chloride in Sodium ChlorideSODIUM CHLORIDE and POTASSIUM CHLORIDEHospira, Inc.ANDACurrent
0990-9257Potassium Chloride in Sodium ChlorideSODIUM CHLORIDE and POTASSIUM CHLORIDEICU Medical Inc.ANDACurrent
0990-9257Potassium Chloride in Sodium ChlorideSODIUM CHLORIDE and POTASSIUM CHLORIDEICU Medical Inc.ANDACurrent
0990-9257Potassium Chloride in Sodium ChlorideSODIUM CHLORIDE and POTASSIUM CHLORIDEICU Medical Inc.ANDACurrent
0990-9257Potassium Chloride in Sodium ChlorideSODIUM CHLORIDE and POTASSIUM CHLORIDEICU Medical Inc.ANDACurrent