Application 201001

Type
ANDA
Sponsor
DR REDDYS LABS LTD

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
0615-7653Donepezil hydrochlorideDonepezil hydrochlorideNCS HealthCare of KY, Inc dba Vangard LabsANDACurrent
0615-7654Donepezil hydrochlorideDonepezil hydrochlorideNCS HealthCare of KY, Inc dba Vangard LabsANDACurrent
55111-356Donepezil hydrochlorideDonepezil hydrochlorideDr. Reddys Laboratories LimitedANDACurrent
55111-356Donepezil hydrochlorideDonepezil hydrochlorideDr. Reddys Laboratories LimitedANDACurrent
55111-357Donepezil hydrochlorideDonepezil hydrochlorideDr. Reddys Laboratories LimitedANDACurrent
55111-357Donepezil hydrochlorideDonepezil hydrochlorideDr. Reddys Laboratories LimitedANDACurrent