FDA.reportPublic FDA data

Application 090073

Type
ANDA
Sponsor
CELLTRION

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
62980-121Memantine HydrochlorideMemantine HydrochlorideVivimed Labs LimitedANDACurrent
62980-122Memantine HydrochlorideMemantine HydrochlorideVivimed Labs LimitedANDACurrent
62980-123Memantine HydrochlorideMemantine HydrochlorideVivimed Labs LimitedANDACurrent
64679-121Memantine HydrochlorideMemantine HydrochlorideWockhardt USA LLC.ANDACurrent
64679-122Memantine HydrochlorideMemantine HydrochlorideWockhardt USA LLC.ANDACurrent
64679-123Memantine HydrochlorideMemantine HydrochlorideWockhardt USA LLC.ANDACurrent
71335-1798Memantine HydrochlorideMemantine HydrochlorideBryant Ranch PrepackANDACurrent
71335-1863Memantine HydrochlorideMemantine HydrochlorideBryant Ranch PrepackANDACurrent
72606-514Memantine HydrochlorideMemantine HydrochlorideCELLTRION USA, INC.ANDACurrent
72606-515Memantine HydrochlorideMemantine HydrochlorideCELLTRION USA, INC.ANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
31448ORIG2016-02-18