FDA.reportPublic FDA data

Application 020690

Type
NDA
Sponsor
EISAI INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ARICEPTDONEPEZIL HYDROCHLORIDETABLET;ORAL10MGYesYes
002ARICEPTDONEPEZIL HYDROCHLORIDETABLET;ORAL5MGYesNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0615-7623donepezil hydrochlorideDONEPEZIL HYDROCHLORIDENCS HealthCare of KY, Inc dba Vangard LabsNDACurrent
0615-7624donepezil hydrochlorideDONEPEZIL HYDROCHLORIDENCS HealthCare of KY, Inc dba Vangard LabsNDACurrent
55289-151Ariceptdonepezil hydrochloridePD-Rx Pharmaceuticals, Inc.NDACurrent
55289-151Ariceptdonepezil hydrochloridePD-Rx Pharmaceuticals, Inc.NDACurrent
55289-151Ariceptdonepezil hydrochloridePD-Rx Pharmaceuticals, Inc.NDACurrent
55289-151Ariceptdonepezil hydrochloridePD-Rx Pharmaceuticals, Inc.NDACurrent
55289-151Ariceptdonepezil hydrochloridePD-Rx Pharmaceuticals, Inc.NDACurrent
62856-245Ariceptdonepezil hydrochlorideEisai Inc.NDACurrent
62856-245Ariceptdonepezil hydrochlorideEisai Inc.NDACurrent
62856-245Ariceptdonepezil hydrochlorideEisai Inc.NDACurrent
62856-245Ariceptdonepezil hydrochlorideEisai Inc.NDACurrent
62856-245Ariceptdonepezil hydrochlorideEisai Inc.NDACurrent
62856-245Ariceptdonepezil hydrochlorideEisai Inc.NDACurrent
62856-245Ariceptdonepezil hydrochlorideEisai Inc.NDACurrent
62856-245Ariceptdonepezil hydrochlorideEisai Inc.NDACurrent
62856-246Ariceptdonepezil hydrochlorideEisai Inc.NDACurrent
62856-246Ariceptdonepezil hydrochlorideEisai Inc.NDACurrent
62856-246Ariceptdonepezil hydrochlorideEisai Inc.NDACurrent
62856-246Ariceptdonepezil hydrochlorideEisai Inc.NDACurrent
62856-246Ariceptdonepezil hydrochlorideEisai Inc.NDACurrent
62856-246Ariceptdonepezil hydrochlorideEisai Inc.NDACurrent
62856-246Ariceptdonepezil hydrochlorideEisai Inc.NDACurrent
62856-246Ariceptdonepezil hydrochlorideEisai Inc.NDACurrent
67046-128Donepezil HydrochlorideDonepezil HydrochlorideContract Pharmacy Services-PANDACurrent
67046-129Donepezil HydrochlorideDonepezil HydrochlorideContract Pharmacy Services-PANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
56932SUPPL2018-12-21
56792SUPPL2018-12-19
35143SUPPL2015-07-22
25519SUPPL2015-07-22
25518SUPPL2013-09-10
35142SUPPL2013-09-09
25516SUPPL2013-04-09
13210SUPPL2012-09-26
25517SUPPL2012-09-06
35141SUPPL2012-03-09
3087SUPPL2012-03-05
20826SUPPL2011-02-15
13209SUPPL2010-12-01
3086SUPPL2010-11-30
35140SUPPL2006-10-18
25515SUPPL2006-10-18
25514SUPPL2004-05-07
57466ORIG1997-04-11