FDA.reportPublic FDA data

Application 090175

Type
ANDA
Sponsor
ZYDUS PHARMS USA INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001DONEPEZIL HYDROCHLORIDEDONEPEZIL HYDROCHLORIDETABLET, ORALLY DISINTEGRATING;ORAL5MGNoNo
002DONEPEZIL HYDROCHLORIDEDONEPEZIL HYDROCHLORIDETABLET, ORALLY DISINTEGRATING;ORAL10MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
65841-721donepezil hydrochloridedonepezil hydrochlorideCadila Healthcare LimitedANDACurrent
65841-721donepezil hydrochloridedonepezil hydrochlorideCadila Healthcare LimitedANDACurrent
65841-721donepezil hydrochloridedonepezil hydrochlorideZydus Lifesciences LimitedANDACurrent
65841-721donepezil hydrochloridedonepezil hydrochlorideCadila Healthcare LimitedANDACurrent
65841-722donepezil hydrochloridedonepezil hydrochlorideCadila Healthcare LimitedANDACurrent
65841-722donepezil hydrochloridedonepezil hydrochlorideCadila Healthcare LimitedANDACurrent
65841-722donepezil hydrochloridedonepezil hydrochlorideZydus Lifesciences LimitedANDACurrent
65841-722donepezil hydrochloridedonepezil hydrochlorideCadila Healthcare LimitedANDACurrent
68382-346donepezil hydrochloridedonepezil hydrochlorideZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-346donepezil hydrochloridedonepezil hydrochlorideZydus Pharmaceuticals USA Inc.ANDACurrent
68382-346donepezil hydrochloridedonepezil hydrochlorideZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-347donepezil hydrochloridedonepezil hydrochlorideZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-347donepezil hydrochloridedonepezil hydrochlorideZydus Pharmaceuticals USA Inc.ANDACurrent
68382-347donepezil hydrochloridedonepezil hydrochlorideZydus Pharmaceuticals (USA) Inc.ANDACurrent