FDA.reportPublic FDA data

Application 065214

Type
NDA
Sponsor
B BRAUN

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001CEFOXITIN AND DEXTROSE IN DUPLEX CONTAINERCEFOXITIN SODIUMINJECTABLE;INJECTIONEQ 1GM BASE/VIALYesYes
002CEFOXITIN AND DEXTROSE IN DUPLEX CONTAINERCEFOXITIN SODIUMINJECTABLE;INJECTIONEQ 2GM BASE/VIALYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0264-3123Cefoxitin and DextroseCEFOXITIN SODIUMB. Braun Medical Inc.NDACurrent
0264-3123Cefoxitin and DextroseCEFOXITIN SODIUMB. Braun Medical Inc.NDACurrent
0264-3123Cefoxitin and DextroseCEFOXITIN SODIUMB. Braun Medical Inc.NDACurrent
0264-3125Cefoxitin and DextroseCEFOXITIN SODIUMB. Braun Medical Inc.NDACurrent
0264-3125Cefoxitin and DextroseCEFOXITIN SODIUMB. Braun Medical Inc.NDACurrent
0264-3125Cefoxitin and DextroseCEFOXITIN SODIUMB. Braun Medical Inc.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
59515SUPPL2019-07-30
59504SUPPL2019-07-30
18335SUPPL2013-06-11
30655SUPPL2013-06-06
18334SUPPL2010-03-03
18333SUPPL2010-02-16