FDA.reportPublic FDA data

Application 018562

Type
NDA
Sponsor
ICU MEDICAL INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001DEXTROSE 40% IN PLASTIC CONTAINERDEXTROSEINJECTABLE;INJECTION40GM/100MLYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0409-7937DextrosedextroseHospira, Inc.NDACurrent
0409-7937DextrosedextroseHospira, Inc.NDACurrent
0990-7937DextrosedextroseICU Medical Inc.NDACurrent
0990-7937DextrosedextroseICU Medical Inc.NDACurrent
0990-7937DextrosedextroseICU Medical Inc.NDACurrent
0990-7937DextrosedextroseICU Medical Inc.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
54239SUPPL2018-05-17
54208SUPPL2018-05-16
946SUPPL2016-02-24
11235SUPPL2016-02-23