Application 016730

Type
NDA
Sponsor
B BRAUN

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001DEXTROSE 5% IN PLASTIC CONTAINERDEXTROSEINJECTABLE;INJECTION5GM/100MLYesYes
002DEXTROSE 5% IN PLASTIC CONTAINERDEXTROSEINJECTABLE;INJECTION50MG/MLYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0264-1510DextroseDextroseB. Braun Medical Inc.NDACurrent
0264-1510DextroseDextroseB. Braun Medical Inc.NDACurrent
0264-1510DextroseDextroseB. Braun Medical Inc.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
85923SUPPL 2026-05-18
85898SUPPL 2026-05-13