FDA.reportPublic FDA data

Application 209955

Type
ANDA
Sponsor
APOTEX

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001MEMANTINE HYDROCHLORIDEMEMANTINE HYDROCHLORIDESOLUTION;ORAL2MG/MLNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
60505-6162MEMANTINEmemantine hydrochlorideApotex Corp.ANDACurrent
60505-6162MEMANTINEmemantine hydrochlorideApotex Corp.ANDACurrent
60505-6162MEMANTINEmemantine hydrochlorideApotex Corp.ANDACurrent