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

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A090043-001MEMANTINE HYDROCHLORIDEMEMANTINE HYDROCHLORIDE5MGTABLET / ORALAB2015-07-31
A090043-002MEMANTINE HYDROCHLORIDEMEMANTINE HYDROCHLORIDE10MGTABLET / ORALAB2015-07-31

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-productTE code
A090043-001AB
A090043-002AB

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-01 22:54:322026-06A090043-001MEMANTINE HYDROCHLORIDE5MGTABLET / ORALAB2015-07-31a50c72e98297…
2026-08-01 22:54:322026-06A090043-002MEMANTINE HYDROCHLORIDE10MGTABLET / ORALAB2015-07-31a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A090043-001AB1a50c72e98297…
2026-08-01 22:54:322026-06A090043-002AB1a50c72e98297…

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Memantine HydrochlorideMEMANTINE HYDROCHLORIDEUpsher-Smith Laboratories, LLC6e0ade9e-b721-4701-bcb7-de464e19e7072025-12-11Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090043
application number: ANDA090043
ndc (product): 0832-1113
ndc (product): 0832-1112

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 6 matching rows.

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