FDA.reportPublic FDA data

Application 202840

Type
ANDA
Sponsor
MACLEODS PHARMS LTD

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
A202840-001MEMANTINE HYDROCHLORIDEMEMANTINE HYDROCHLORIDE5MGTABLET / ORALAB2015-10-13
A202840-002MEMANTINE HYDROCHLORIDEMEMANTINE HYDROCHLORIDE10MGTABLET / ORALAB2015-10-13

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A202840-001AB
A202840-002AB

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 22:54:322026-06A202840-001MEMANTINE HYDROCHLORIDE5MGTABLET / ORALAB2015-10-13a50c72e98297…
2026-08-01 22:54:322026-06A202840-002MEMANTINE HYDROCHLORIDE10MGTABLET / ORALAB2015-10-13a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A202840-001AB1a50c72e98297…
2026-08-01 22:54:322026-06A202840-002AB1a50c72e98297…

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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Memantine HydrochlorideMEMANTINE HYDROCHLORIDEA-S Medication Solutions66db6d61-cf1d-46ca-a645-19e9a20f46172023-11-24Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202840
application number: ANDA202840
ndc (product): 50090-5832
Memantine HydrochlorideMEMANTINE HYDROCHLORIDEMacleods Pharmaceuticals Limited989fa756-7d70-4ea7-bb5e-f4395e48589d2022-12-31Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202840
application number: ANDA202840
ndc (product): 33342-298
ndc (product): 33342-297

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 14 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
33342-297Memantine HydrochlorideMemantine HydrochlorideMacleods Pharmaceuticals LimitedANDACurrent
33342-297Memantine HydrochlorideMemantine HydrochlorideMacleods Pharmaceuticals LimitedANDACurrent
33342-297Memantine HydrochlorideMemantine HydrochlorideMacleods Pharmaceuticals LimitedANDACurrent
33342-297Memantine HydrochlorideMemantine HydrochlorideMacleods Pharmaceuticals LimitedANDACurrent
33342-298Memantine HydrochlorideMemantine HydrochlorideMacleods Pharmaceuticals LimitedANDACurrent
33342-298Memantine HydrochlorideMemantine HydrochlorideMacleods Pharmaceuticals LimitedANDACurrent
33342-298Memantine HydrochlorideMemantine HydrochlorideMacleods Pharmaceuticals LimitedANDACurrent
33342-298Memantine HydrochlorideMemantine HydrochlorideMacleods Pharmaceuticals LimitedANDACurrent
50090-5832Memantine HydrochlorideMemantine HydrochlorideA-S Medication SolutionsANDACurrent
50090-5832Memantine HydrochlorideMemantine HydrochlorideA-S Medication SolutionsANDACurrent
68788-7165Memantine HydrochlorideMemantine HydrochloridePreferred Pharmaceuticals Inc.ANDACurrent
68788-7165Memantine HydrochlorideMemantine HydrochloridePreferred Pharmaceuticals Inc.ANDACurrent
68788-7165Memantine HydrochlorideMemantine HydrochloridePreferred Pharmaceuticals Inc.ANDACurrent
68788-7165Memantine HydrochlorideMemantine HydrochloridePreferred Pharmaceuticals Inc.ANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
32325ORIG2014-08-29