Application 018090

Type
NDA
Sponsor
ICU MEDICAL INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINERSODIUM CHLORIDEINJECTABLE;INJECTION450MG/100MLYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0409-7730Sodium ChlorideSODIUM CHLORIDEHospira, Inc.NDACurrent
0409-7730Sodium ChlorideSODIUM CHLORIDEHospira, Inc.NDACurrent
0409-7985Sodium ChlorideSODIUM CHLORIDEHospira, Inc.NDACurrent
0409-7985Sodium ChlorideSODIUM CHLORIDEHospira, Inc.NDACurrent
0409-7985Sodium ChlorideSODIUM CHLORIDEHospira, Inc.NDACurrent
0990-7730Sodium ChlorideSODIUM CHLORIDEICU Medical Inc.NDACurrent
0990-7730Sodium ChlorideSODIUM CHLORIDEICU Medical Inc.NDACurrent
0990-7730Sodium ChlorideSODIUM CHLORIDEICU Medical Inc.NDACurrent
0990-7730Sodium ChlorideSODIUM CHLORIDEICU Medical Inc.NDACurrent
0990-7730Sodium ChlorideSODIUM CHLORIDEICU Medical Inc.NDACurrent
0990-7730Sodium ChlorideSODIUM CHLORIDEICU Medical Inc.NDACurrent
0990-7985Sodium ChlorideSODIUM CHLORIDEICU Medical Inc.NDACurrent
0990-7985Sodium ChlorideSODIUM CHLORIDEICU Medical Inc.NDACurrent
0990-7985Sodium ChlorideSODIUM CHLORIDEICU Medical Inc.NDACurrent
0990-7985Sodium ChlorideSODIUM CHLORIDEICU Medical Inc.NDACurrent
0990-7985Sodium ChlorideSODIUM CHLORIDEICU Medical Inc.NDACurrent
0990-7985Sodium ChlorideSODIUM CHLORIDEICU Medical Inc.NDACurrent
0990-7985Sodium ChlorideSODIUM CHLORIDEICU Medical Inc.NDACurrent
0990-7985Sodium ChlorideSODIUM CHLORIDEICU Medical Inc.NDACurrent
0990-7985Sodium ChlorideSODIUM CHLORIDEICU Medical Inc.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
49833SUPPL2017-09-22
49829SUPPL2017-09-21
49762SUPPL2017-09-18