FDA.reportPublic FDA data

Application 203034

Type
ANDA
Sponsor
HETERO LABS LTD V

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
31722-737DonepezilDonepezil hydrochlorideCamber Pharmaceuticals, Inc.ANDACurrent
31722-737DonepezilDonepezil hydrochlorideCamber Pharmaceuticals, Inc.ANDACurrent
31722-738DonepezilDonepezil hydrochlorideCamber Pharmaceuticals, Inc.ANDACurrent
31722-738DonepezilDonepezil hydrochlorideCamber Pharmaceuticals, Inc.ANDACurrent
50090-2627DonepezilDonepezil hydrochlorideA-S Medication SolutionsANDACurrent
50090-2627DonepezilDonepezil hydrochlorideA-S Medication SolutionsANDACurrent
50090-2627DonepezilDonepezil hydrochlorideA-S Medication SolutionsANDACurrent
50090-2627DonepezilDonepezil hydrochlorideA-S Medication SolutionsANDACurrent
50090-2627DonepezilDonepezil hydrochlorideA-S Medication SolutionsANDACurrent
50090-2627DonepezilDonepezil hydrochlorideA-S Medication SolutionsANDACurrent
50090-2910Donepezil hydrochlorideDonepezil hydrochlorideA-S Medication SolutionsANDACurrent
50090-2910DonepezilDonepezil hydrochlorideA-S Medication SolutionsANDACurrent
50090-2910Donepezil hydrochlorideDonepezil hydrochlorideA-S Medication SolutionsANDACurrent
50090-2910Donepezil hydrochlorideDonepezil hydrochlorideA-S Medication SolutionsANDACurrent
60687-292DonepezilDonepezil hydrochlorideAmerican Health PackagingANDACurrent
60687-292DonepezilDonepezil hydrochlorideAmerican Health PackagingANDACurrent
60687-292DonepezilDonepezil hydrochlorideAmerican Health PackagingANDACurrent
60687-303DonepezilDonepezil hydrochlorideAmerican Health PackagingANDACurrent
60687-303DonepezilDonepezil hydrochlorideAmerican Health PackagingANDACurrent
60687-303DonepezilDonepezil hydrochlorideAmerican Health PackagingANDACurrent
68071-3183DonepezilDonepezil hydrochlorideNuCarePharmaceuticals, Inc.ANDACurrent
68071-3192DonepezilDonepezil hydrochlorideNuCare Pharmaceuticals, Inc.ANDACurrent
68071-3198DonepezilDonepezil hydrochlorideNuCare Pharmaceuticals, Inc.ANDACurrent
68071-3198DonepezilDonepezil hydrochlorideNuCare Pharmaceuticals, Inc.ANDACurrent
68071-3198DonepezilDonepezil hydrochlorideNuCare Pharmaceuticals, Inc.ANDACurrent
68071-4613DonepezilDonepezil hydrochlorideNuCare Pharmaceuticals,Inc.ANDACurrent
68071-4613DonepezilDonepezil hydrochlorideNuCare Pharmaceuticals,Inc.ANDACurrent
68071-4615DonepezilDonepezil hydrochlorideNuCare Pharmaceuticals,Inc.ANDACurrent
68071-4615DonepezilDonepezil hydrochlorideNuCare Pharmaceuticals,Inc.ANDACurrent
68554-5037Donepezil HydrochlorideDonepezil HydrochlorideHetero Labs LimitedANDACurrent
68554-5038Donepezil HydrochlorideDonepezil HydrochlorideHetero Labs LimitedANDACurrent
68788-7632DonepezilDonepezil hydrochloridePreferred Pharmaceuticals Inc.ANDACurrent
71335-0792DonepezilDonepezil hydrochlorideBryant Ranch PrepackANDACurrent
71335-0792DonepezilDonepezil hydrochlorideBryant Ranch PrepackANDACurrent