FDA.reportPublic FDA data

Application 200891

Type
ANDA
Sponsor
ALEMBIC 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
A200891-001MEMANTINE HYDROCHLORIDEMEMANTINE HYDROCHLORIDE5MGTABLET / ORALAB2015-10-13
A200891-002MEMANTINE 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
A200891-001AB
A200891-002AB

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 22:54:322026-06A200891-001MEMANTINE HYDROCHLORIDE5MGTABLET / ORALAB2015-10-13a50c72e98297…
2026-08-01 22:54:322026-06A200891-002MEMANTINE HYDROCHLORIDE10MGTABLET / ORALAB2015-10-13a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A200891-001AB1a50c72e98297…
2026-08-01 22:54:322026-06A200891-002AB1a50c72e98297…

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 HYDROCHLORIDEAlembic Pharmaceuticals Limitedb86c0f6e-480b-40e7-aa4d-21bd0659101d2023-01-30Warnings, Adverse reactionsExact identifier
application applno (ANDA): 200891
application number: ANDA200891
ndc (product): 46708-452
ndc (product): 46708-451
Memantine HydrochlorideMEMANTINE HYDROCHLORIDEAlembic Pharmaceuticals Inc.af2b73da-1be4-4b7f-929b-acb3b9a10f782021-10-11Warnings, Adverse reactionsExact identifier
application applno (ANDA): 200891
application number: ANDA200891
ndc (product): 62332-076
ndc (product): 62332-075

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 11 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
43353-165Memantine Hydrochloridememantine hydrochlorideAphena Pharma Solutions - Tennessee, LLCANDACurrent
46708-451Memantine Hydrochloridememantine hydrochlorideAlembic Pharmaceuticals LimitedANDACurrent
46708-451Memantine Hydrochloridememantine hydrochlorideAlembic Pharmaceuticals LimitedANDACurrent
46708-452Memantine Hydrochloridememantine hydrochlorideAlembic Pharmaceuticals LimitedANDACurrent
46708-452Memantine Hydrochloridememantine hydrochlorideAlembic Pharmaceuticals LimitedANDACurrent
62332-075Memantine Hydrochloridememantine hydrochlorideAlembic Pharmaceuticals Inc.ANDACurrent
62332-075Memantine Hydrochloridememantine hydrochlorideAlembic Pharmaceuticals Inc.ANDACurrent
62332-075Memantine Hydrochloridememantine hydrochlorideAlembic Pharmaceuticals Inc.ANDACurrent
62332-076Memantine Hydrochloridememantine hydrochlorideAlembic Pharmaceuticals Inc.ANDACurrent
62332-076Memantine Hydrochloridememantine hydrochlorideAlembic Pharmaceuticals Inc.ANDACurrent
62332-076Memantine Hydrochloridememantine hydrochlorideAlembic Pharmaceuticals Inc.ANDACurrent