FDA.reportPublic FDA data

Application 017514

Type
NDA
Sponsor
ICU MEDICAL INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINERSODIUM CHLORIDESOLUTION;IRRIGATION900MG/100MLNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0409-6138Sodium ChlorideSODIUM CHLORIDEHospira, Inc.NDACurrent
0409-6138Sodium ChlorideSODIUM CHLORIDEHospira, Inc.NDACurrent
0409-6138Sodium ChlorideSODIUM CHLORIDEHospira, Inc.NDACurrent
0409-7138Sodium ChlorideSODIUM CHLORIDEHospira, Inc.NDACurrent
0409-7138Sodium ChlorideSODIUM CHLORIDEHospira, Inc.NDACurrent
0409-7138Sodium ChlorideSODIUM CHLORIDEHospira, Inc.NDACurrent
0990-6138Sodium ChlorideSODIUM CHLORIDEICU Medical Inc.NDACurrent
0990-6138Sodium ChlorideSODIUM CHLORIDEICU Medical Inc.NDACurrent
0990-6138Sodium ChlorideSODIUM CHLORIDEICU Medical Inc.NDACurrent
0990-6138Sodium ChlorideSODIUM CHLORIDEICU Medical Inc.NDACurrent
0990-7138Sodium ChlorideSODIUM CHLORIDEICU Medical Inc.NDACurrent
0990-7138Sodium ChlorideSODIUM CHLORIDEICU Medical Inc.NDACurrent
0990-7138Sodium ChlorideSODIUM CHLORIDEICU Medical Inc.NDACurrent
0990-7138Sodium ChlorideSODIUM CHLORIDEICU Medical Inc.NDACurrent
51662-13010.9% SODIUM CHLORIDE0.9% SODIUM CHLORIDEHF Acquisition Co LLC, DBA HealthFirstNDACurrent
51662-13010.9% SODIUM CHLORIDE0.9% SODIUM CHLORIDEHF Acquisition Co LLC, DBA HealthFirstNDACurrent
51662-13010.9% SODIUM CHLORIDE0.9% SODIUM CHLORIDEHF Acquisition Co LLC, DBA HealthFirstNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
13163SUPPL2004-04-29