FDA.reportPublic FDA data

Application 090100

Type
ANDA
Sponsor
CADILA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001DONEPEZIL HYDROCHLORIDEDONEPEZIL HYDROCHLORIDETABLET;ORAL5MGNoNo
002DONEPEZIL HYDROCHLORIDEDONEPEZIL HYDROCHLORIDETABLET;ORAL10MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
65841-749donepezil hydrochloridedonepezil hydrochlorideCadila Healthcare LimitedANDACurrent
65841-749donepezil hydrochloridedonepezil hydrochlorideZydus Lifesciences LimitedANDACurrent
65841-749donepezil hydrochloridedonepezil hydrochlorideCadila Healthcare LimitedANDACurrent
65841-749donepezil hydrochloridedonepezil hydrochlorideCadila Healthcare LimitedANDACurrent
65841-750donepezil hydrochloridedonepezil hydrochlorideCadila Healthcare LimitedANDACurrent
65841-750donepezil hydrochloridedonepezil hydrochlorideZydus Lifesciences LimitedANDACurrent
65841-750donepezil hydrochloridedonepezil hydrochlorideCadila Healthcare LimitedANDACurrent
65841-750donepezil hydrochloridedonepezil hydrochlorideCadila Healthcare LimitedANDACurrent
68382-302donepezil hydrochloridedonepezil hydrochlorideZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-302donepezil hydrochloridedonepezil hydrochlorideZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-303donepezil hydrochloridedonepezil hydrochlorideZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-303donepezil hydrochloridedonepezil hydrochlorideZydus Pharmaceuticals (USA) Inc.ANDACurrent