FDA.reportPublic FDA data

Application 050821

Type
NDA
Sponsor
B BRAUN

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001CEFEPIME AND DEXTROSE IN DUPLEX CONTAINERCEFEPIME HYDROCHLORIDEINJECTABLE;INJECTIONEQ 1GM BASE/VIALNoNo
002CEFEPIME AND DEXTROSE IN DUPLEX CONTAINERCEFEPIME HYDROCHLORIDEINJECTABLE;INJECTIONEQ 2GM BASE/VIALNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0264-3193CEFEPIME HYDROCHLORIDE AND DEXTROSECEFEPIME HYDROCHLORIDEB. Braun Medical Inc.NDACurrent
0264-3193CEFEPIME HYDROCHLORIDE AND DEXTROSECEFEPIME HYDROCHLORIDEB. Braun Medical Inc.NDACurrent
0264-3195CEFEPIME HYDROCHLORIDE AND DEXTROSECEFEPIME HYDROCHLORIDEB. Braun Medical Inc.NDACurrent
0264-3195CEFEPIME HYDROCHLORIDE AND DEXTROSECEFEPIME HYDROCHLORIDEB. Braun Medical Inc.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
85666SUPPL 2026-04-10
85655SUPPL 2026-04-09
70592SUPPL2022-03-24
70572SUPPL2022-03-21
39391SUPPL2015-11-13
8341SUPPL2015-11-13
39390SUPPL2014-06-10
30614SUPPL2014-06-10
39389SUPPL2012-09-11
8340SUPPL2012-09-10
42755ORIG2010-08-30
24350ORIG2010-08-30
18300ORIG2010-05-17
8339ORIG2010-05-10