FDA.reportPublic FDA data

Application 022568

Type
NDA
Sponsor
EISAI INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ARICEPTDONEPEZIL HYDROCHLORIDETABLET;ORAL23MGYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
62856-247Ariceptdonepezil hydrochlorideEisai Inc.NDACurrent
62856-247Ariceptdonepezil hydrochlorideEisai Inc.NDACurrent
62856-247Ariceptdonepezil hydrochlorideEisai Inc.NDACurrent
62856-247Ariceptdonepezil hydrochlorideEisai Inc.NDACurrent
62856-247Ariceptdonepezil hydrochlorideEisai Inc.NDACurrent
62856-247Ariceptdonepezil hydrochlorideEisai Inc.NDACurrent
62856-247Ariceptdonepezil hydrochlorideEisai Inc.NDACurrent
62856-247Ariceptdonepezil hydrochlorideEisai Inc.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
56790SUPPL2018-12-19
38847SUPPL2015-07-22
7544SUPPL2015-07-22
7543SUPPL2013-09-10
38846SUPPL2013-09-09
17719SUPPL2012-09-26
29867SUPPL2012-09-06
38845SUPPL2012-03-09
7542SUPPL2012-03-05
24343ORIG2011-02-17
42559ORIG2010-12-01
38844SUPPL2010-12-01
29866SUPPL2010-11-30
38843ORIG2010-07-30
7541ORIG2010-07-28