FDA.reportPublic FDA data

Application 206528

Type
ANDA
Sponsor
AJANTA 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
27241-070Memantine HydrochlorideMemantine HydrochlorideAjanta Pharma LimitedANDACurrent
27241-070Memantine HydrochlorideMemantine HydrochlorideAjanta Pharma USA Inc.ANDACurrent
27241-070Memantine HydrochlorideMemantine HydrochlorideAjanta Pharma LimitedANDACurrent
27241-070Memantine HydrochlorideMemantine HydrochlorideAjanta Pharma USA Inc.ANDACurrent
27241-071Memantine HydrochlorideMemantine HydrochlorideAjanta Pharma LimitedANDACurrent
27241-071Memantine HydrochlorideMemantine HydrochlorideAjanta Pharma USA Inc.ANDACurrent
27241-071Memantine HydrochlorideMemantine HydrochlorideAjanta Pharma LimitedANDACurrent
27241-071Memantine HydrochlorideMemantine HydrochlorideAjanta Pharma USA Inc.ANDACurrent
63629-7333Memantine HydrochlorideMemantine HydrochlorideBryant Ranch PrepackANDACurrent
71335-0346Memantine HydrochlorideMemantine HydrochlorideBryant Ranch PrepackANDACurrent
71335-0346Memantine HydrochlorideMemantine HydrochlorideBryant Ranch PrepackANDACurrent
71335-0346Memantine HydrochlorideMemantine HydrochlorideBryant Ranch PrepackANDACurrent
71335-1899Memantine HydrochlorideMemantine HydrochlorideBryant Ranch PrepackANDACurrent
71335-1899Memantine HydrochlorideMemantine HydrochlorideBryant Ranch PrepackANDACurrent