FDA.reportPublic FDA data

Application 091267

Type
ANDA
Sponsor
WOCKHARDT

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
42254-305DONEPEZIL HYDROCHLORIDEDONEPEZIL HYDROCHLORIDERebel Distributors CorpANDACurrent
55648-311Donepezil HydrochlorideDonepezil HydrochlorideWockhardt LimitedANDACurrent
55648-312Donepezil HydrochlorideDonepezil HydrochlorideWockhardt LimitedANDACurrent
64679-311Donepezil HydrochlorideDonepezil HydrochlorideWockhardt USA LLC.ANDACurrent
64679-312Donepezil HydrochlorideDonepezil HydrochlorideWockhardt USA LLC.ANDACurrent