FDA.reportPublic FDA data

Application 079225

Type
ANDA
Sponsor
MYLAN

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
0378-1103Memantine HydrochloridememantineMylan Pharmaceuticals Inc.ANDACurrent
0378-1103Memantine HydrochloridememantineMylan Pharmaceuticals Inc.ANDACurrent
0378-1104Memantine HydrochloridememantineMylan Pharmaceuticals Inc.ANDACurrent
0378-1104Memantine HydrochloridememantineMylan Pharmaceuticals Inc.ANDACurrent
42292-005Memantine HydrochloridememantineMylan Institutional Inc.ANDACurrent
42292-006Memantine HydrochloridememantineMylan Institutional Inc.ANDACurrent
63629-7090Memantine HydrochloridememantineBryant Ranch PrepackANDACurrent
63629-7090Memantine HydrochloridememantineBryant Ranch PrepackANDACurrent