FDA.reportPublic FDA data

Application 203175

Type
ANDA
Sponsor
AUROBINDO PHARMA LTD

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
63629-7154Memantine HydrochlorideMemantine HydrochlorideBryant Ranch PrepackANDACurrent
63629-7154Memantine HydrochlorideMemantine HydrochlorideBryant Ranch PrepackANDACurrent
65862-652Memantine HydrochlorideMemantine HydrochlorideAurobindo Pharma LimitedANDACurrent
65862-652Memantine HydrochlorideMemantine HydrochlorideAurobindo Pharma LimitedANDACurrent
65862-652Memantine HydrochlorideMemantine HydrochlorideAurobindo Pharma LimitedANDACurrent
65862-652Memantine HydrochlorideMemantine HydrochlorideAurobindo Pharma LimitedANDACurrent
65862-653Memantine HydrochlorideMemantine HydrochlorideAurobindo Pharma LimitedANDACurrent
65862-653Memantine HydrochlorideMemantine HydrochlorideAurobindo Pharma LimitedANDACurrent
65862-653Memantine HydrochlorideMemantine HydrochlorideAurobindo Pharma LimitedANDACurrent
65862-653Memantine HydrochlorideMemantine HydrochlorideAurobindo Pharma LimitedANDACurrent