FDA.reportPublic FDA data

Application 208277

Type
NDA
Sponsor
EISAI INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001FYCOMPAPERAMPANELSUSPENSION;ORAL0.5MG/MLYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
62856-290FycompaperampanelEisai Inc.NDACurrent
62856-290FycompaperampanelEisai Inc.NDACurrent
62856-290FycompaperampanelEisai Inc.NDACurrent
62856-290FycompaperampanelEisai Inc.NDACurrent
62856-290FycompaperampanelEisai Inc.NDACurrent
62856-290FycompaperampanelEisai Inc.NDACurrent
62856-290FycompaperampanelEisai Inc.NDACurrent
62856-290FycompaperampanelEisai Inc.NDACurrent
62856-290FycompaperampanelEisai Inc.NDACurrent
62856-290FycompaperampanelEisai Inc.NDACurrent
62856-290FycompaperampanelEisai Inc.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
80886SUPPL 2025-01-21
80885SUPPL 2025-01-21
74656SUPPL 2023-06-29
74655SUPPL 2023-06-29
58951SUPPL2019-06-04
58902SUPPL2019-05-31
58901SUPPL2019-05-31
55802SUPPL2018-10-03
55801SUPPL2018-10-03
55764SUPPL2018-10-01
50485ORIG2017-11-27
49133SUPPL2017-07-28
49132SUPPL2017-07-28
49106SUPPL2017-07-28
32903ORIG2016-05-06
40631ORIG2016-05-03
66470ORIG1900-01-01
66469ORIG1900-01-01
66468ORIG1900-01-01
66467ORIG1900-01-01
63224ORIG1900-01-01
51558ORIG1900-01-01
51557ORIG1900-01-01
51556ORIG1900-01-01