FDA.reportPublic FDA data

Application 021911

Type
NDA
Sponsor
EISAI INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001BANZELRUFINAMIDETABLET;ORAL100MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**YesNo
002BANZELRUFINAMIDETABLET;ORAL200MGYesNo
003BANZELRUFINAMIDETABLET;ORAL400MGYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
62856-582BanzelrufinamideEisai Inc.NDACurrent
62856-582BanzelrufinamideEisai Inc.NDACurrent
62856-582BanzelrufinamideEisai Inc.NDACurrent
62856-582BanzelrufinamideEisai Inc.NDACurrent
62856-582BanzelrufinamideEisai Inc.NDACurrent
62856-582BanzelrufinamideEisai Inc.NDACurrent
62856-582BanzelrufinamideEisai Inc.NDACurrent
62856-582BanzelrufinamideEisai Inc.NDACurrent
62856-583BanzelrufinamideEisai Inc.NDACurrent
62856-583BanzelrufinamideEisai Inc.NDACurrent
62856-583BanzelrufinamideEisai Inc.NDACurrent
62856-583BanzelrufinamideEisai Inc.NDACurrent
62856-583BanzelrufinamideEisai Inc.NDACurrent
62856-583BanzelrufinamideEisai Inc.NDACurrent
62856-583BanzelrufinamideEisai Inc.NDACurrent
62856-583BanzelrufinamideEisai Inc.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
61108SUPPL2019-12-02
61109SUPPL2019-11-29
61092SUPPL2019-11-29
16564SUPPL2015-07-01
28835SUPPL2015-06-26
37869SUPPL2015-03-03
6439SUPPL2015-02-17
52328SUPPL2015-01-13
52327SUPPL2015-01-13
28834SUPPL2011-06-03
6438SUPPL2011-03-08
16563SUPPL2011-03-07
28833SUPPL2010-11-10
16562SUPPL2010-11-08
6437SUPPL2009-11-24
44657ORIG2009-02-19
42348ORIG2009-02-19
28832ORIG2008-11-18
37868ORIG2008-11-17