FDA.reportPublic FDA data

Application 090768

Type
ANDA
Sponsor
JUBILANT GENERICS

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
0179-0208DONEPEZIL HYDROCHLORIDEDONEPEZIL HYDROCHLORIDEKAISER FOUNDATION HOSPITALSANDACurrent
59746-329DONEPEZIL HYDROCHLORIDEDONEPEZIL HYDROCHLORIDEJubilant Cadista Pharmaceuticals Inc.ANDACurrent
59746-329DONEPEZIL HYDROCHLORIDEDONEPEZIL HYDROCHLORIDEJubilant Cadista Pharmaceuticals Inc.ANDACurrent
59746-330DONEPEZIL HYDROCHLORIDEDONEPEZIL HYDROCHLORIDEJubilant Cadista Pharmaceuticals Inc.ANDACurrent
59746-330DONEPEZIL HYDROCHLORIDEDONEPEZIL HYDROCHLORIDEJubilant Cadista Pharmaceuticals Inc.ANDACurrent
63187-401DONEPEZIL HYDROCHLORIDEDONEPEZIL HYDROCHLORIDEProficient Rx LPANDACurrent
63187-401DONEPEZIL HYDROCHLORIDEDONEPEZIL HYDROCHLORIDEProficient Rx LPANDACurrent