FDA.reportPublic FDA data

Application 050780

Type
NDA
Sponsor
B BRAUN

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001CEFUROXIME AND DEXTROSE IN DUPLEX CONTAINERCEFUROXIME SODIUMINJECTABLE;INJECTIONEQ 750MG BASE/VIALYesYes
002CEFUROXIME AND DEXTROSE IN DUPLEX CONTAINERCEFUROXIME SODIUMINJECTABLE;INJECTIONEQ 1.5GM BASE/VIALYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0264-3112Cefuroxime and DextroseCEFUROXIME AND DEXTROSEB. Braun Medical Inc.NDACurrent
0264-3112Cefuroxime and DextroseCEFUROXIME AND DEXTROSEB. Braun Medical Inc.NDACurrent
0264-3114Cefuroxime and DextroseCEFUROXIME AND DEXTROSEB. Braun Medical Inc.NDACurrent
0264-3114Cefuroxime and DextroseCEFUROXIME AND DEXTROSEB. Braun Medical Inc.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
65550SUPPL2020-12-09
65523SUPPL2020-12-08
39322SUPPL2015-05-04
30528SUPPL2015-05-04
18233SUPPL2007-09-11
8273SUPPL2007-09-11
30527SUPPL2005-05-17
30526SUPPL2004-07-01
8272SUPPL2003-08-29
42733ORIG2001-02-21
18232ORIG2001-02-21
8271ORIG2001-02-21