FDA.reportPublic FDA data

Application 090043

Type
ANDA
Sponsor
UPSHER SMITH LABS

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
0832-1112Memantine HydrochlorideMemantine HydrochlorideUpsher-Smith Laboratories, LLCANDACurrent
0832-1112Memantine HydrochlorideMemantine HydrochlorideUpsher-Smith Laboratories, LLCANDACurrent
0832-1113Memantine HydrochlorideMemantine HydrochlorideUpsher-Smith Laboratories, LLCANDACurrent
0832-1113Memantine HydrochlorideMemantine HydrochlorideUpsher-Smith Laboratories, LLCANDACurrent
43353-170Memantine HydrochlorideMemantine HydrochlorideAphena Pharma Solutions - Tennessee, LLCANDACurrent
43353-170Memantine HydrochlorideMemantine HydrochlorideAphena Pharma Solutions - Tennessee, LLCANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
31444ORIG2016-02-18