Application 019466

Type
NDA
Sponsor
HOSPIRA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001DEXTROSE 5% IN PLASTIC CONTAINERDEXTROSEINJECTABLE;INJECTION5GM/100MLYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0409-7100Dextrosedextrose monohydrateHospira, Inc.NDACurrent
0409-7100Dextrosedextrose monohydrateHospira, Inc.NDACurrent
0409-7100Dextrosedextrose monohydrateHospira, Inc.NDACurrent
0409-7100Dextrosedextrose monohydrateHospira, Inc.NDACurrent
0409-7100Dextrosedextrose monohydrateHospira, Inc.NDACurrent
0409-7100Dextrosedextrose monohydrateHospira, Inc.NDACurrent
0409-7100Dextrosedextrose monohydrateHospira, Inc.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
82498SUPPL 2025-06-09
82485SUPPL 2025-06-09
1336SUPPL2016-06-14