FDA.reportPublic FDA data

Application 050796

Type
NDA
Sponsor
B BRAUN

Application Products#

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

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0264-3153CEFTRIAXONE AND DEXTROSECEFTRIAXONEB. Braun Medical Inc.NDACurrent
0264-3153CEFTRIAXONE AND DEXTROSECEFTRIAXONEB. Braun Medical Inc.NDACurrent
0264-3153CEFTRIAXONE AND DEXTROSECEFTRIAXONEB. Braun Medical Inc.NDACurrent
0264-3153CEFTRIAXONE AND DEXTROSECEFTRIAXONEB. Braun Medical Inc.NDACurrent
0264-3155CEFTRIAXONE AND DEXTROSECEFTRIAXONEB. Braun Medical Inc.NDACurrent
0264-3155CEFTRIAXONE AND DEXTROSECEFTRIAXONEB. Braun Medical Inc.NDACurrent
0264-3155CEFTRIAXONE AND DEXTROSECEFTRIAXONEB. Braun Medical Inc.NDACurrent
0264-3155CEFTRIAXONE AND DEXTROSECEFTRIAXONEB. Braun Medical Inc.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
69888SUPPL2022-01-18
69881SUPPL2022-01-14
66730SUPPL2021-03-10
66707SUPPL2021-03-10
64548SUPPL2020-09-10
64544SUPPL2020-09-10
8313SUPPL2015-07-13
18277SUPPL2015-07-10
18276SUPPL2013-04-16
8312SUPPL2013-04-16
30582SUPPL2013-03-13
39358SUPPL2013-03-11
39356SUPPL2012-02-07
30581SUPPL2012-02-07
39357SUPPL2010-07-01
8311SUPPL2010-06-30
30580SUPPL2008-12-19
8310SUPPL2008-12-19
39355SUPPL2007-09-11
8309SUPPL2007-09-11
42743ORIG2007-07-02
18275ORIG2005-04-28
8308ORIG2005-04-28