FDA.reportPublic FDA data

Application 090247

Type
ANDA
Sponsor
HIKMA PHARMS

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
0143-9747Donepezil HydrochlorideDonepezil HydrochlorideHikma Pharmaceuticals USA Inc.ANDACurrent
0143-9747Donepezil HydrochlorideDonepezil HydrochlorideWest-ward Pharmaceutical CorpANDACurrent
0143-9748Donepezil HydrochlorideDonepezil HydrochlorideHikma Pharmaceuticals USA Inc.ANDACurrent
0143-9748Donepezil HydrochlorideDonepezil HydrochlorideWest-ward Pharmaceutical CorpANDACurrent
59115-109Donepezil HydrochlorideDonepezil HydrochlorideHikma PharmaceuticalANDACurrent
59115-109Donepezil HydrochlorideDonepezil HydrochlorideHikma PharmaceuticalANDACurrent
59115-110Donepezil HydrochlorideDonepezil HydrochlorideHikma PharmaceuticalANDACurrent
59115-110Donepezil HydrochlorideDonepezil HydrochlorideHikma PharmaceuticalANDACurrent