FDA.reportPublic FDA data

Application 018564

Type
NDA
Sponsor
ICU MEDICAL INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001DEXTROSE 20% IN PLASTIC CONTAINERDEXTROSEINJECTABLE;INJECTION20GM/100MLYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0409-7935DextrosedextroseHospira, Inc.NDACurrent
0409-7935DextrosedextroseHospira, Inc.NDACurrent
0990-7935DextrosedextroseICU Medical Inc.NDACurrent
0990-7935DextrosedextroseICU Medical Inc.NDACurrent
0990-7935DextrosedextroseICU Medical Inc.NDACurrent
0990-7935DextrosedextroseICU Medical Inc.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
54241SUPPL2018-05-17
54210SUPPL2018-05-16
15031SUPPL2016-02-24
11237SUPPL2016-02-23