FDA.reportPublic FDA data

Application 022525

Type
NDA
Sponsor
FOREST LABS LLC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001NAMENDA XRMEMANTINE HYDROCHLORIDECAPSULE, EXTENDED RELEASE;ORAL7MGYesNo
002NAMENDA XRMEMANTINE HYDROCHLORIDECAPSULE, EXTENDED RELEASE;ORAL14MGYesNo
003NAMENDA XRMEMANTINE HYDROCHLORIDECAPSULE, EXTENDED RELEASE;ORAL21MGYesNo
004NAMENDA XRMEMANTINE HYDROCHLORIDECAPSULE, EXTENDED RELEASE;ORAL28MGYesYes

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

Orange Book products#

Current product rows page 1 of 1 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N022525-001NAMENDA XRMEMANTINE HYDROCHLORIDE7MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CAPSULE, EXTENDED RELEASE / ORALRLD2010-06-21
N022525-002NAMENDA XRMEMANTINE HYDROCHLORIDE14MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CAPSULE, EXTENDED RELEASE / ORALRLD2010-06-21
N022525-003NAMENDA XRMEMANTINE HYDROCHLORIDE21MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CAPSULE, EXTENDED RELEASE / ORALRLD2010-06-21
N022525-004NAMENDA XRMEMANTINE HYDROCHLORIDE28MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CAPSULE, EXTENDED RELEASE / ORALRLD2010-06-21

Orange Book patents#

Current patent rows page 1 of 1 · 8 matching rows.

Application-product, Patent, Expiration table
Application-productPatentExpirationUse codeCoverage / statusSubmission date
N022525-00180390092029-03-24U-5392011-11-16
N022525-0018039009*PED2029-09-24Pediatric extension
N022525-00280390092029-03-24U-539
N022525-0028039009*PED2029-09-24Pediatric extension
N022525-00380390092029-03-24U-539
N022525-0038039009*PED2029-09-24Pediatric extension
N022525-00480390092029-03-24U-539
N022525-0048039009*PED2029-09-24Pediatric extension

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 22:54:322026-06N022525-001NAMENDA XR7MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CAPSULE, EXTENDED RELEASE / ORALRLD2010-06-21a50c72e98297…
2026-08-01 22:54:322026-06N022525-002NAMENDA XR14MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CAPSULE, EXTENDED RELEASE / ORALRLD2010-06-21a50c72e98297…
2026-08-01 22:54:322026-06N022525-003NAMENDA XR21MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CAPSULE, EXTENDED RELEASE / ORALRLD2010-06-21a50c72e98297…
2026-08-01 22:54:322026-06N022525-004NAMENDA XR28MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CAPSULE, EXTENDED RELEASE / ORALRLD2010-06-21a50c72e98297…

Observed Orange Book patent history#

Captured, Edition, Application-product table
CapturedEditionApplication-productPatentExpirationUse codeCoverage / statusSubmission dateSource SHA-256
2026-08-01 22:54:322026-06N022525-00180390092029-03-24U-5392011-11-16a50c72e98297…
2026-08-01 22:54:322026-06N022525-0018039009*PED2029-09-24Pediatric extensiona50c72e98297…
2026-08-01 22:54:322026-06N022525-00280390092029-03-24U-539a50c72e98297…
2026-08-01 22:54:322026-06N022525-0028039009*PED2029-09-24Pediatric extensiona50c72e98297…
2026-08-01 22:54:322026-06N022525-00380390092029-03-24U-539a50c72e98297…
2026-08-01 22:54:322026-06N022525-0038039009*PED2029-09-24Pediatric extensiona50c72e98297…
2026-08-01 22:54:322026-06N022525-00480390092029-03-24U-539a50c72e98297…
2026-08-01 22:54:322026-06N022525-0048039009*PED2029-09-24Pediatric extensiona50c72e98297…

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 3 · 59 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
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 HYDROCHLORIDEREMEDYREPACK INC.cbfd9d95-f50b-45ff-9857-9f1712c45e562026-04-08Warnings, 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
Memantine HydrochlorideMEMANTINE HYDROCHLORIDEAphena Pharma Solutions - Tennessee, LLC3662b11a-354a-b683-e063-6394a90a00862025-05-30Warnings, Adverse reactionsName fallback
generic name: MEMANTINE HYDROCHLORIDE

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 33 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0456-3400Namendamemantine hydrochlorideAllergan, Inc.NDACurrent
0456-3400Namendamemantine hydrochlorideAllergan, Inc.NDACurrent
0456-3407Namendamemantine hydrochlorideAllergan, Inc.NDACurrent
0456-3407Namendamemantine hydrochlorideAllergan, Inc.NDACurrent
0456-3407Namendamemantine hydrochlorideAllergan, Inc.NDACurrent
0456-3407Namendamemantine hydrochlorideAllergan, Inc.NDACurrent
0456-3414Namendamemantine hydrochlorideAllergan, Inc.NDACurrent
0456-3414Namendamemantine hydrochlorideAllergan, Inc.NDACurrent
0456-3414Namendamemantine hydrochlorideAllergan, Inc.NDACurrent
0456-3414Namendamemantine hydrochlorideAllergan, Inc.NDACurrent
0456-3421Namendamemantine hydrochlorideAllergan, Inc.NDACurrent
0456-3421Namendamemantine hydrochlorideAllergan, Inc.NDACurrent
0456-3421Namendamemantine hydrochlorideAllergan, Inc.NDACurrent
0456-3421Namendamemantine hydrochlorideAllergan, Inc.NDACurrent
0456-3428Namendamemantine hydrochlorideAllergan, Inc.NDACurrent
0456-3428Namendamemantine hydrochlorideAllergan, Inc.NDACurrent
0456-3428Namendamemantine hydrochlorideAllergan, Inc.NDACurrent
0456-3428Namendamemantine hydrochlorideAllergan, Inc.NDACurrent
60505-6208Memantine Hydrochloridememantine hydrochlorideApotex CorpNDACurrent
60505-6208Memantine Hydrochloridememantine hydrochlorideApotex CorpNDACurrent
60505-6208Memantine Hydrochloridememantine hydrochlorideApotex CorpNDACurrent
60505-6209Memantine Hydrochloridememantine hydrochlorideApotex CorpNDACurrent
60505-6209Memantine Hydrochloridememantine hydrochlorideApotex CorpNDACurrent
60505-6209Memantine Hydrochloridememantine hydrochlorideApotex CorpNDACurrent
60505-6210Memantine Hydrochloridememantine hydrochlorideApotex CorpNDACurrent
60505-6210Memantine Hydrochloridememantine hydrochlorideApotex CorpNDACurrent
60505-6210Memantine Hydrochloridememantine hydrochlorideApotex CorpNDACurrent
60505-6211Memantine Hydrochloridememantine hydrochlorideApotex CorpNDACurrent
60505-6211Memantine Hydrochloridememantine hydrochlorideApotex CorpNDACurrent
60505-6211Memantine Hydrochloridememantine hydrochlorideApotex CorpNDACurrent
68151-5755Namendamemantine hydrochlorideCarilion Materials ManagementNDACurrent
68151-5817Namendamemantine hydrochlorideCarilion Materials ManagementNDACurrent
68151-5829Namenda XRmemantine hydrochlorideCarilion Materials ManagementNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
61095SUPPL2019-11-29
61053SUPPL2019-11-26
7499SUPPL2014-10-01
38812SUPPL2014-09-30
38811SUPPL2014-07-09
29830SUPPL2014-07-07
24332ORIG2010-12-23
22045ORIG2010-12-23
29829ORIG2010-06-24
17680ORIG2010-06-02
58108ORIG1900-01-01
51327ORIG1900-01-01
51326ORIG1900-01-01
51325ORIG1900-01-01