FDA.reportPublic FDA data

Application 019345

Type
NDA
Sponsor
ICU MEDICAL INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001DEXTROSE 30% IN PLASTIC CONTAINERDEXTROSEINJECTABLE;INJECTION30GM/100MLYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0409-8004DextrosedextroseHospira, Inc.NDACurrent
0409-8004DextrosedextroseHospira, Inc.NDACurrent
0990-8004DextrosedextroseICU Medical Inc.NDACurrent
0990-8004DextrosedextroseICU Medical Inc.NDACurrent
0990-8004DextrosedextroseICU Medical Inc.NDACurrent
0990-8004DextrosedextroseICU Medical Inc.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
54242SUPPL2018-05-17
54209SUPPL2018-05-16
1289SUPPL2016-02-24
33727SUPPL2016-02-23