FDA.reportPublic FDA data

Application 090290

Type
ANDA
Sponsor
SANDOZ

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
0781-5274Donepezil HydrochlorideDonepezil HydrochlorideSandoz IncANDACurrent
0781-5274Donepezil HydrochlorideDonepezil HydrochlorideSandoz IncANDACurrent
0781-5275Donepezil HydrochlorideDonepezil HydrochlorideSandoz IncANDACurrent
0781-5275Donepezil HydrochlorideDonepezil HydrochlorideSandoz IncANDACurrent
63739-646Donepezil HydrochlorideDonepezil HydrochlorideMcKesson CorporationANDACurrent
63739-646Donepezil HydrochlorideDonepezil HydrochlorideMcKesson Corporation dba SKY PackagingANDACurrent
63739-678Donepezil HydrochlorideDonepezil HydrochlorideMcKesson CorporationANDACurrent
63739-678Donepezil HydrochlorideDonepezil HydrochlorideMcKesson Corporation dba SKY PackagingANDACurrent