FDA.reportPublic FDA data

Application 201367

Type
NDA
Sponsor
EISAI INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001BANZELRUFINAMIDESUSPENSION;ORAL40MG/MLYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
62856-584BanzelrufinamideEisai Inc.NDACurrent
62856-584BanzelrufinamideEisai Inc.NDACurrent
62856-584BanzelrufinamideEisai Inc.NDACurrent
62856-584BanzelrufinamideEisai Inc.NDACurrent
62856-584BanzelrufinamideEisai Inc.NDACurrent
62856-584BanzelrufinamideEisai Inc.NDACurrent
62856-584BanzelrufinamideEisai Inc.NDACurrent
62856-584BanzelrufinamideEisai Inc.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
75703SUPPL 2023-10-11
75702SUPPL 2023-10-10
75701SUPPL 2023-10-10
61111SUPPL2019-11-29
61110SUPPL2019-11-29
61093SUPPL2019-11-29
40067SUPPL2015-07-01
32108SUPPL2015-06-26
40066SUPPL2015-03-03
32107SUPPL2015-02-17
44835ORIG2011-07-06
22850ORIG2011-07-06
9888SUPPL2011-06-03
32106ORIG2011-03-08
19015ORIG2011-03-07
64329ORIG1900-01-01
58115ORIG1900-01-01
51474ORIG1900-01-01
51473ORIG1900-01-01