FDA.reportPublic FDA data

Application 210319

Type
ANDA
Sponsor
MEDLEY PHARMS

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
13925-540Memantine HydrochlorideMemantine Hydrochloride OralSeton PharmaceuticalsANDACurrent
42934-300Memantine HydrochlorideMemantine Hydrochloride OralMedley Pharmaceuticals LimitedANDACurrent