FDA.reportPublic FDA data

Application 021487

Type
NDA
Sponsor
ALLERGAN

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001NAMENDAMEMANTINE HYDROCHLORIDETABLET;ORAL5MGYesNo
002NAMENDAMEMANTINE HYDROCHLORIDETABLET;ORAL10MGYesYes

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
N021487-001NAMENDAMEMANTINE HYDROCHLORIDE5MGTABLET / ORALRLD2003-10-16
N021487-002NAMENDAMEMANTINE HYDROCHLORIDE10MGTABLET / ORALRLD2003-10-16

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 22:54:322026-06N021487-001NAMENDA5MGTABLET / ORALRLD2003-10-16a50c72e98297…
2026-08-01 22:54:322026-06N021487-002NAMENDA10MGTABLET / ORALRLD2003-10-16a50c72e98297…

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 · 3 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
memantine hydrochlorideMEMANTINE HYDROCHLORIDECardinal Health 107, LLCe5754973-e73b-4a25-abb4-80f91880f0182026-06-05Warnings, Adverse reactionsExact identifier
application applno (NDA): 021487
application number: NDA021487
ndc (product): 55154-2666
ndc (product): 55154-2667
memantine hydrochlorideMEMANTINE HYDROCHLORIDEActavis Pharma, Inc.72973b46-f307-4a9e-8fb1-ad2cbccfd7362018-11-01Warnings, Adverse reactionsExact identifier
application applno (NDA): 021487
application number: NDA021487
ndc (product): 0591-3870
ndc (product): 0591-3875
ndc (product): 0591-3900
memantine hydrochlorideMEMANTINE HYDROCHLORIDEAphena Pharma Solutions - Tennessee, LLCc8f5c20b-4573-44c5-89fc-4da11b2e1fe12017-11-30Warnings, Adverse reactionsExact identifier
application applno (NDA): 021487
application number: NDA021487
ndc (product): 71610-011

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 58 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0456-3200NamendaMemantine HydrochlorideAllergan, Inc.NDACurrent
0456-3200NamendaMemantine HydrochlorideAllergan, Inc.NDACurrent
0456-3200NamendaMemantine HydrochlorideAllergan, Inc.NDACurrent
0456-3200NamendaMemantine HydrochlorideAllergan, Inc.NDACurrent
0456-3200NamendaMemantine HydrochlorideAllergan, Inc.NDACurrent
0456-3205Namendamemantine hydrochlorideAllergan, Inc.NDACurrent
0456-3205Namendamemantine hydrochlorideAllergan, Inc.NDACurrent
0456-3205Namendamemantine hydrochlorideAllergan, Inc.NDACurrent
0456-3205Namendamemantine hydrochlorideAllergan, Inc.NDACurrent
0456-3205Namendamemantine hydrochlorideAllergan, Inc.NDACurrent
0456-3210Namendamemantine hydrochlorideAllergan, Inc.NDACurrent
0456-3210Namendamemantine hydrochlorideAllergan, Inc.NDACurrent
0456-3210Namendamemantine hydrochlorideAllergan, Inc.NDACurrent
0456-3210Namendamemantine hydrochlorideAllergan, Inc.NDACurrent
0456-3210Namendamemantine hydrochlorideAllergan, Inc.NDACurrent
0591-3011memantine hydrochloridememantine hydrochlorideActavis Pharma, IncNDACurrent
0591-3870memantine hydrochloridememantine hydrochlorideActavis Pharma, Inc.NDACurrent
0591-3870memantine hydrochloridememantine hydrochlorideActavis Pharma, Inc.NDACurrent
0591-3870memantine hydrochloridememantine hydrochlorideActavis Pharma, IncNDACurrent
0591-3870memantine hydrochloridememantine hydrochlorideActavis Pharma, Inc.NDACurrent
0591-3870memantine hydrochloridememantine hydrochlorideActavis Pharma, Inc.NDACurrent
0591-3870memantine hydrochloridememantine hydrochlorideActavis Pharma, Inc.NDACurrent
0591-3875memantine hydrochloridememantine hydrochlorideActavis Pharma, Inc.NDACurrent
0591-3875memantine hydrochloridememantine hydrochlorideActavis Pharma, Inc.NDACurrent
0591-3875memantine hydrochloridememantine hydrochlorideActavis Pharma, IncNDACurrent
0591-3875memantine hydrochloridememantine hydrochlorideActavis Pharma, Inc.NDACurrent
0591-3875memantine hydrochloridememantine hydrochlorideActavis Pharma, Inc.NDACurrent
0591-3875memantine hydrochloridememantine hydrochlorideActavis Pharma, Inc.NDACurrent
0591-3900memantine hydrochloridememantine hydrochlorideActavis Pharma, Inc.NDACurrent
0591-3900memantine hydrochloridememantine hydrochlorideActavis Pharma, Inc.NDACurrent
0591-3900memantine hydrochloridememantine hydrochlorideActavis Pharma, IncNDACurrent
0591-3900memantine hydrochloridememantine hydrochlorideActavis Pharma, Inc.NDACurrent
0591-3900memantine hydrochloridememantine hydrochlorideActavis Pharma, Inc.NDACurrent
0591-3900memantine hydrochloridememantine hydrochlorideActavis Pharma, Inc.NDACurrent
21695-169Namendamemantine hydrochlorideRebel Distributors CorpNDACurrent
21695-232Namendamemantine hydrochlorideRebel Distributors CorpNDACurrent
55154-2666memantine hydrochloridememantine hydrochlorideCardinal Health 107, LLCNDACurrent
55154-2666memantine hydrochloridememantine hydrochlorideCardinal HealthNDACurrent
55154-2666memantine hydrochloridememantine hydrochlorideCardinal HealthNDACurrent
55154-2666memantine hydrochloridememantine hydrochlorideCardinal HealthNDACurrent
55154-2666memantine hydrochloridememantine hydrochlorideCardinal HealthNDACurrent
55154-2667memantine hydrochloridememantine hydrochlorideCardinal Health 107, LLCNDACurrent
55154-2667memantine hydrochloridememantine hydrochlorideCardinal HealthNDACurrent
55154-2667memantine hydrochloridememantine hydrochlorideCardinal HealthNDACurrent
55154-2667memantine hydrochloridememantine hydrochlorideCardinal HealthNDACurrent
55154-4617NamendaMemantine HydrochlorideCardinal HealthNDACurrent
55154-4617NamendaMemantine HydrochlorideCardinal HealthNDACurrent
55154-4618NamendaMemantine HydrochlorideCardinal HealthNDACurrent
55289-937Namendamemantine hydrochloridePD-Rx Pharmaceuticals, Inc.NDACurrent
55289-937Namendamemantine hydrochloridePD-Rx Pharmaceuticals, Inc.NDACurrent
55289-937Namendamemantine hydrochloridePD-Rx Pharmaceuticals, Inc.NDACurrent
55289-937Namendamemantine hydrochloridePD-Rx Pharmaceuticals, Inc.NDACurrent
63629-3383Namendamemantine hydrochlorideBryant Ranch PrepackNDACurrent
63629-3383Namendamemantine hydrochlorideBryant Ranch PrepackNDACurrent
63629-5291Namendamemantine hydrochlorideBryant Ranch PrepackNDACurrent
63629-5291Namendamemantine hydrochlorideBryant Ranch PrepackNDACurrent
67046-489Namendamemantine hydrochlorideContract Pharmacy Services-PANDACurrent
71610-011memantine hydrochloridememantine hydrochlorideAphena Pharma Solutions - Tennessee, LLCNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
56434SUPPL2018-11-14
56283SUPPL2018-11-06
37054SUPPL2013-10-25
27916SUPPL2013-10-25
15585SUPPL2013-10-25
15584SUPPL2013-10-25
5522SUPPL2013-10-25
5521SUPPL2013-10-25
5520SUPPL2006-10-13
27915SUPPL2006-04-21
5519SUPPL2005-05-20
27914SUPPL2005-05-03
27913SUPPL2004-09-29
42191ORIG2003-12-31
27912ORIG2003-10-22
15583ORIG2003-10-20