FDA.reportPublic FDA data

Application 021627

Type
NDA
Sponsor
ALLERGAN

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001NAMENDAMEMANTINE HYDROCHLORIDESOLUTION;ORAL2MG/MLYesNo

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N021627-001NAMENDAMEMANTINE HYDROCHLORIDE2MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**SOLUTION / ORALRLD2005-04-18

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.

Product history page 2 of 2 · 44 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2022-10-28 04:53 UTC2022-10N021627-001NAMENDA2MG/MLSOLUTION / ORALRLD2005-04-18f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09N021627-001NAMENDA2MG/MLSOLUTION / ORALRLD2005-04-18e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07N021627-001NAMENDA2MG/MLSOLUTION / ORALRLD2005-04-18cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N021627-001NAMENDA2MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**SOLUTION / ORALRLD2005-04-18a50c72e98297…

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 3 · 58 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
MEMANTINE HYDROCHLORIDEMEMANTINE HYDROCHLORIDENCS HealthCare of KY, LLC dba Vangard Labs007d4cb9-3fa9-40f3-b5ca-4083eccd60382026-09-01Warnings, Adverse reactionsName fallback
generic name: MEMANTINE HYDROCHLORIDE
Memantine HydrochlorideMEMANTINE HYDROCHLORIDEREMEDYREPACK INC.cbfd9d95-f50b-45ff-9857-9f1712c45e562026-08-06Warnings, Adverse reactionsName fallback
generic name: MEMANTINE HYDROCHLORIDE
Memantine HydrochlorideMEMANTINE HYDROCHLORIDEPreferred Pharmaceuticals Inc.becb09dc-174d-4817-88d4-f38c8adcd3092026-06-17Warnings, Adverse reactionsName fallback
generic name: MEMANTINE HYDROCHLORIDE
Memantine HydrochlorideMEMANTINE HYDROCHLORIDEMajor Pharmaceuticalsd0a5e0fc-04e3-417d-bef3-9b309ff715972026-06-09Warnings, Adverse reactionsName fallback
generic name: MEMANTINE HYDROCHLORIDE
memantine hydrochlorideMEMANTINE HYDROCHLORIDECardinal Health 107, LLCe5754973-e73b-4a25-abb4-80f91880f0182026-06-05Warnings, Adverse reactionsName fallback
generic name: MEMANTINE HYDROCHLORIDE
Memantine HydrochlorideMEMANTINE HYDROCHLORIDEBryant Ranch Prepackafc07196-be28-4521-afc0-d4aa5b6fd46d2026-05-20Warnings, Adverse reactionsName fallback
generic name: MEMANTINE HYDROCHLORIDE
Memantine HydrochlorideMEMANTINE HYDROCHLORIDESlate Run Pharmaceuticals, LLCa74050c4-5a37-4fa1-85d9-85831525cfeb2026-04-21Warnings, Adverse reactionsName fallback
generic name: MEMANTINE HYDROCHLORIDE
MEMANTINE HYDROCHLORIDEMEMANTINE HYDROCHLORIDEDirectRxd0839a2d-35f1-1f14-e053-2995a90ad5492026-03-06Warnings, Adverse reactionsName fallback
generic name: MEMANTINE HYDROCHLORIDE
Memantine HydrochlorideMEMANTINE HYDROCHLORIDEChartwell Governmental & Specialty RX, LLC.d1f97615-e888-421e-b50a-95a87a1965ff2026-02-06Warnings, Adverse reactionsName fallback
generic name: MEMANTINE HYDROCHLORIDE
Memantine HydrochlorideMEMANTINE HYDROCHLORIDEChartwell RX, LLCa7b76864-6de7-45f6-be5b-5ecfca8116272026-01-30Warnings, Adverse reactionsName fallback
generic name: MEMANTINE HYDROCHLORIDE
Memantine HydrochlorideMEMANTINE HYDROCHLORIDECardinal Health 107, LLC65c9e7bc-71f0-4113-8de1-4fcaa591735f2026-01-15Warnings, Adverse reactionsName fallback
generic name: MEMANTINE HYDROCHLORIDE
memantine hydrochlorideMEMANTINE HYDROCHLORIDELupin Pharmaceuticals, Inc.24290655-47f3-4042-a977-a832c5161d2c2026-01-15Warnings, Adverse reactionsName fallback
generic name: MEMANTINE HYDROCHLORIDE
Memantine HydrochlorideMEMANTINE HYDROCHLORIDEAphena Pharma Solutions - Tennessee, LLC47e4a696-fe2a-c905-e063-6294a90a74152026-01-08Warnings, Adverse reactionsName fallback
generic name: MEMANTINE HYDROCHLORIDE
Memantine HydrochlorideMEMANTINE HYDROCHLORIDEAvPAK11d27c75-fdc0-f9da-e063-6394a90ac6b02026-01-08Warnings, Adverse reactionsName fallback
generic name: MEMANTINE HYDROCHLORIDE
memantine hydrochlorideMEMANTINE HYDROCHLORIDEMajor Pharmaceuticalsf6ce7cca-d245-44f2-986c-2a8d85dbb5fb2026-01-07Warnings, Adverse reactionsName fallback
generic name: MEMANTINE HYDROCHLORIDE
Memantine hydrochlorideMEMANTINE HYDROCHLORIDELupin Pharmaceuticals, Inc.1b4a0162-9cb4-4ba6-8c02-95c2955734ae2025-12-29Warnings, Adverse reactionsName fallback
generic name: MEMANTINE HYDROCHLORIDE
Memantine HydrochlorideMEMANTINE HYDROCHLORIDEUpsher-Smith Laboratories, LLC6e0ade9e-b721-4701-bcb7-de464e19e7072025-12-11Warnings, Adverse reactionsName fallback
generic name: MEMANTINE HYDROCHLORIDE
Memantine HydrochlorideMEMANTINE HYDROCHLORIDEAjanta Pharma USA Inc.292671f2-f221-4a3d-a110-a266a9527e042025-11-27Warnings, Adverse reactionsName fallback
generic name: MEMANTINE HYDROCHLORIDE
Memantine hydrochlorideMEMANTINE HYDROCHLORIDEMacleods Pharmaceuticals Limited62e32b0b-1eb2-424d-bfd2-d27ef27d35f32025-10-14Warnings, Adverse reactionsName fallback
generic name: MEMANTINE HYDROCHLORIDE
Memantine HydrochlorideMEMANTINE HYDROCHLORIDECarlsbad Technology, Inc.30b4d5c4-0a31-c385-e063-6394a90adbce2025-06-23Warnings, Adverse reactionsName fallback
generic name: MEMANTINE HYDROCHLORIDE

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
28263SUPPL2014-08-12
15886SUPPL2014-08-12
37351SUPPL2013-10-25
28262SUPPL2013-10-25
42238ORIG2006-10-18
28261SUPPL2006-10-13
5876SUPPL2006-04-21
37350ORIG2005-04-19
5875ORIG2005-04-19