FDA.reportPublic FDA data

Application 202114

Type
ANDA
Sponsor
CSPC OUYI

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
69844-037DONEPEZIL HYDROCHLORIDEDONEPEZIL HYDROCHLORIDEGraviti Pharmaceuticals Private LimitedANDACurrent
69844-037DONEPEZIL HYDROCHLORIDEDONEPEZIL HYDROCHLORIDEGraviti Pharmaceuticals Private LimitedANDACurrent
69844-038DONEPEZIL HYDROCHLORIDEDONEPEZIL HYDROCHLORIDEGraviti Pharmaceuticals Private LimitedANDACurrent
69844-038DONEPEZIL HYDROCHLORIDEDONEPEZIL HYDROCHLORIDEGraviti Pharmaceuticals Private LimitedANDACurrent