FDA.reportPublic FDA data

Application 204831

Type
ANDA
Sponsor
UNICHEM LABS LTD

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
29300-250donepezil hydrochloridedonepezil hydrochlorideUnichem Pharmaceuticals (ANDACurrent
29300-250donepezil hydrochloridedonepezil hydrochlorideUnichem Pharmaceuticals (USA), Inc.ANDACurrent
29300-250donepezil hydrochloridedonepezil hydrochlorideUnichem Pharmaceuticals (USA), Inc.ANDACurrent
29300-251donepezil hydrochloridedonepezil hydrochlorideUnichem Pharmaceuticals (ANDACurrent
29300-251donepezil hydrochloridedonepezil hydrochlorideUnichem Pharmaceuticals (USA), Inc.ANDACurrent
29300-251donepezil hydrochloridedonepezil hydrochlorideUnichem Pharmaceuticals (USA), Inc.ANDACurrent