FDA.reportPublic FDA data

Application 065430

Type
NDA
Sponsor
B BRAUN

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001CEFOTETAN AND DEXTROSE IN DUPLEX CONTAINERCEFOTETAN DISODIUMINJECTABLE;INJECTIONEQ 1GM BASE/VIALYesYes
002CEFOTETAN AND DEXTROSE IN DUPLEX CONTAINERCEFOTETAN DISODIUMINJECTABLE;INJECTIONEQ 2GM BASE/VIALYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0264-3173Cefotetan and DextroseCEFOTETAN and DEXTROSEB. Braun Medical Inc.NDACurrent
0264-3173Cefotetan and DextroseCEFOTETAN and DEXTROSEB. Braun Medical Inc.NDACurrent
0264-3173Cefotetan and DextroseCEFOTETAN and DEXTROSEB. Braun Medical Inc.NDACurrent
0264-3175Cefotetan and DextroseCEFOTETAN and DEXTROSEB. Braun Medical Inc.NDACurrent
0264-3175Cefotetan and DextroseCEFOTETAN and DEXTROSEB. Braun Medical Inc.NDACurrent
0264-3175Cefotetan and DextroseCEFOTETAN and DEXTROSEB. Braun Medical Inc.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
61745SUPPL2020-01-31
61744SUPPL2020-01-31
30661ORIG2007-08-14