FDA.reportPublic FDA data

Application 017607

Type
NDA
Sponsor
ICU MEDICAL INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINERDEXTROSE; SODIUM CHLORIDEINJECTABLE;INJECTION5GM/100ML;450MG/100MLYesNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0409-7926Dextrose and Sodium ChlorideDEXTROSE MONOHYDRATE and SODIUM CHLORIDEHospira, Inc.NDACurrent
0409-7926Dextrose and Sodium ChlorideDEXTROSE MONOHYDRATE and SODIUM CHLORIDEHospira, Inc.NDACurrent
0409-7926Dextrose and Sodium ChlorideDEXTROSE MONOHYDRATE and SODIUM CHLORIDEHospira, Inc.NDACurrent
0990-7926Dextrose and Sodium ChlorideDEXTROSE MONOHYDRATE and SODIUM CHLORIDEICU Medical Inc.NDACurrent
0990-7926Dextrose and Sodium ChlorideDEXTROSE MONOHYDRATE and SODIUM CHLORIDEICU Medical Inc.NDACurrent
0990-7926Dextrose and Sodium ChlorideDEXTROSE MONOHYDRATE and SODIUM CHLORIDEICU Medical Inc.NDACurrent
0990-7926Dextrose and Sodium ChlorideDEXTROSE MONOHYDRATE and SODIUM CHLORIDEICU Medical Inc.NDACurrent
0990-7926Dextrose and Sodium ChlorideDEXTROSE MONOHYDRATE and SODIUM CHLORIDEICU Medical Inc.NDACurrent
0990-7926Dextrose and Sodium ChlorideDEXTROSE MONOHYDRATE and SODIUM CHLORIDEICU Medical Inc.NDACurrent
0990-7926Dextrose and Sodium ChlorideDEXTROSE MONOHYDRATE and SODIUM CHLORIDEICU Medical Inc.NDACurrent
0990-7926Dextrose and Sodium ChlorideDEXTROSE MONOHYDRATE and SODIUM CHLORIDEICU Medical Inc.NDACurrent
0990-7926Dextrose and Sodium ChlorideDEXTROSE MONOHYDRATE and SODIUM CHLORIDEICU Medical Inc.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
55963SUPPL2018-10-17
55954SUPPL2018-10-16