FDA.reportPublic FDA data

Application 202834

Type
NDA
Sponsor
EISAI INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001FYCOMPAPERAMPANELTABLET;ORAL2MGYesNo
002FYCOMPAPERAMPANELTABLET;ORAL4MGYesNo
003FYCOMPAPERAMPANELTABLET;ORAL6MGYesNo
004FYCOMPAPERAMPANELTABLET;ORAL8MGYesNo
005FYCOMPAPERAMPANELTABLET;ORAL10MGYesNo
006FYCOMPAPERAMPANELTABLET;ORAL12MGYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
62856-272FycompaperampanelEisai Inc.NDACurrent
62856-272FycompaperampanelEisai Inc.NDACurrent
62856-272FycompaperampanelEisai Inc.NDACurrent
62856-272FycompaperampanelEisai Inc.NDACurrent
62856-272FycompaperampanelEisai Inc.NDACurrent
62856-272FycompaperampanelEisai Inc.NDACurrent
62856-272FycompaperampanelEisai Inc.NDACurrent
62856-272FycompaperampanelEisai Inc.NDACurrent
62856-272FycompaperampanelEisai Inc.NDACurrent
62856-272FycompaperampanelEisai Inc.NDACurrent
62856-272FycompaperampanelEisai Inc.NDACurrent
62856-274FycompaperampanelEisai Inc.NDACurrent
62856-274FycompaperampanelEisai Inc.NDACurrent
62856-274FycompaperampanelEisai Inc.NDACurrent
62856-274FycompaperampanelEisai Inc.NDACurrent
62856-274FycompaperampanelEisai Inc.NDACurrent
62856-274FycompaperampanelEisai Inc.NDACurrent
62856-274FycompaperampanelEisai Inc.NDACurrent
62856-274FycompaperampanelEisai Inc.NDACurrent
62856-274FycompaperampanelEisai Inc.NDACurrent
62856-274FycompaperampanelEisai Inc.NDACurrent
62856-274FycompaperampanelEisai Inc.NDACurrent
62856-276FycompaperampanelEisai Inc.NDACurrent
62856-276FycompaperampanelEisai Inc.NDACurrent
62856-276FycompaperampanelEisai Inc.NDACurrent
62856-276FycompaperampanelEisai Inc.NDACurrent
62856-276FycompaperampanelEisai Inc.NDACurrent
62856-276FycompaperampanelEisai Inc.NDACurrent
62856-276FycompaperampanelEisai Inc.NDACurrent
62856-276FycompaperampanelEisai Inc.NDACurrent
62856-276FycompaperampanelEisai Inc.NDACurrent
62856-276FycompaperampanelEisai Inc.NDACurrent
62856-276FycompaperampanelEisai Inc.NDACurrent
62856-278FycompaperampanelEisai Inc.NDACurrent
62856-278FycompaperampanelEisai Inc.NDACurrent
62856-278FycompaperampanelEisai Inc.NDACurrent
62856-278FycompaperampanelEisai Inc.NDACurrent
62856-278FycompaperampanelEisai Inc.NDACurrent
62856-278FycompaperampanelEisai Inc.NDACurrent
62856-278FycompaperampanelEisai Inc.NDACurrent
62856-278FycompaperampanelEisai Inc.NDACurrent
62856-278FycompaperampanelEisai Inc.NDACurrent
62856-278FycompaperampanelEisai Inc.NDACurrent
62856-278FycompaperampanelEisai Inc.NDACurrent
62856-280FycompaperampanelEisai Inc.NDACurrent
62856-280FycompaperampanelEisai Inc.NDACurrent
62856-280FycompaperampanelEisai Inc.NDACurrent
62856-280FycompaperampanelEisai Inc.NDACurrent
62856-280FycompaperampanelEisai Inc.NDACurrent
62856-280FycompaperampanelEisai Inc.NDACurrent
62856-280FycompaperampanelEisai Inc.NDACurrent
62856-280FycompaperampanelEisai Inc.NDACurrent
62856-280FycompaperampanelEisai Inc.NDACurrent
62856-280FycompaperampanelEisai Inc.NDACurrent
62856-280FycompaperampanelEisai Inc.NDACurrent
62856-282FycompaperampanelEisai Inc.NDACurrent
62856-282FycompaperampanelEisai Inc.NDACurrent
62856-282FycompaperampanelEisai Inc.NDACurrent
62856-282FycompaperampanelEisai Inc.NDACurrent
62856-282FycompaperampanelEisai Inc.NDACurrent
62856-282FycompaperampanelEisai Inc.NDACurrent
62856-282FycompaperampanelEisai Inc.NDACurrent
62856-282FycompaperampanelEisai Inc.NDACurrent
62856-282FycompaperampanelEisai Inc.NDACurrent
62856-282FycompaperampanelEisai Inc.NDACurrent
62856-282FycompaperampanelEisai Inc.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
77585SUPPL 2024-02-20
76749SUPPL 2024-02-20
75969SUPPL 2023-10-27
75961SUPPL 2023-10-27
58950SUPPL2019-06-04
58904SUPPL2019-05-31
58903SUPPL2019-05-31
55803SUPPL2018-10-03
55800SUPPL2018-10-03
55763SUPPL2018-10-01
49134SUPPL2017-07-28
49131SUPPL2017-07-28
49105SUPPL2017-07-28
45828SUPPL2016-11-08
45824SUPPL2016-11-07
32323SUPPL2015-06-24
19391SUPPL2015-06-23
19392SUPPL2014-11-20
32324SUPPL2014-11-17
32322SUPPL2014-02-26
19390SUPPL2014-02-19
10122SUPPL2014-02-19
19389SUPPL2013-07-11
10121SUPPL2013-07-03
22900ORIG2012-11-28
40231ORIG2012-10-26
10120ORIG2012-10-26
63234SUPPL1900-01-01
63233SUPPL1900-01-01
63232SUPPL1900-01-01
63223SUPPL1900-01-01
63222SUPPL1900-01-01
63221SUPPL1900-01-01
63220SUPPL1900-01-01
52950SUPPL1900-01-01
52949SUPPL1900-01-01
52948SUPPL1900-01-01
52947SUPPL1900-01-01
51562ORIG1900-01-01
51561ORIG1900-01-01
51559ORIG1900-01-01
51465SUPPL1900-01-01
51464SUPPL1900-01-01