FDA.reportPublic FDA data

Application 204389

Type
ANDA
Sponsor
HETERO LABS LTD V

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001MEMANTINE HYDROCHLORIDEMEMANTINE HYDROCHLORIDETABLET;ORAL5MGNoNo
002MEMANTINE HYDROCHLORIDEMEMANTINE HYDROCHLORIDETABLET;ORAL10MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
31722-807memantine hydrochloridememantine hydrochlorideCamber Pharmaceuticals, Inc.ANDACurrent
31722-808memantine hydrochloridememantine hydrochlorideCamber Pharmaceuticals, Inc.ANDACurrent