FDA.reportPublic FDA data

Application 050823

Type
NDA
Sponsor
B BRAUN

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001CEFTAZIDIME IN DEXTROSE CONTAINERCEFTAZIDIMEINJECTABLE;INJECTIONEQ 1GM BASEYesNo
002CEFTAZIDIME IN DEXTROSE CONTAINERCEFTAZIDIMEINJECTABLE;INJECTIONEQ 2GM BASEYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0264-3143Ceftazidime and DextroseCEFTAZIDIMEB. Braun Medical Inc.NDACurrent
0264-3143Ceftazidime and DextroseCEFTAZIDIMEB. Braun Medical Inc.NDACurrent
0264-3143Ceftazidime and DextroseCEFTAZIDIMEB. Braun Medical Inc.NDACurrent
0264-3145Ceftazidime and DextroseCEFTAZIDIMEB. Braun Medical Inc.NDACurrent
0264-3145Ceftazidime and DextroseCEFTAZIDIMEB. Braun Medical Inc.NDACurrent
0264-3145Ceftazidime and DextroseCEFTAZIDIMEB. Braun Medical Inc.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
69079SUPPL2021-10-25
69053SUPPL2021-10-21
59514SUPPL2019-07-30
59506SUPPL2019-07-30
39392SUPPL2015-05-21
8343SUPPL2015-05-19
42756ORIG2012-06-05
24351ORIG2012-06-05
8342ORIG2011-06-27