FDA.reportPublic FDA data

Application 090551

Type
ANDA
Sponsor
STRIDES PHARMA

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
42582-311Donepezil HyrochlorideDonepezil HydrochlorideBi-Coastal Pharma International LLCANDACurrent
42582-312Donepezil HydrochlorideDonepezil HydrochlorideBi-Coastal Pharma International LLCANDACurrent
62980-504Donepezil HyrochlorideDonepezil HydrochlorideVivimed Labs LimitedANDACurrent
62980-505Donepezil HydrochlorideDonepezil HydrochlorideVivimed Labs LimitedANDACurrent
62980-907Donepezil HyrochlorideDonepezil HydrochlorideVivimed Labs LimitedANDACurrent
62980-908Donepezil HyrochlorideDonepezil HydrochlorideVivimed Labs LimitedANDACurrent
64380-907Donepezil HyrochlorideDonepezil HydrochlorideStrides Pharma Inc.ANDACurrent
64380-907DONEPEZIL HYDROCHLORIDEDONEPEZIL HYDROCHLORIDEStrides Pharma Science LimitedANDACurrent
64380-908Donepezil HydrochlorideDonepezil HydrochlorideStrides Pharma Inc.ANDACurrent
64380-908DONEPEZIL HYDROCHLORIDEDONEPEZIL HYDROCHLORIDEStrides Pharma Science LimitedANDACurrent
69150-415Donepezil Hydrochloridedonepezil hydrochlorideBIOMES PHARMACEUTICALS LLCANDACurrent
69150-416Donepezil Hydrochloridedonepezil hydrochlorideBIOMES PHARMACEUTICALS LLCANDACurrent