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

NDC Listings For This Application#

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, Inc.NDACurrent
0591-3900memantine hydrochloridememantine hydrochlorideActavis Pharma, IncNDACurrent
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 HealthNDACurrent
55154-2667memantine hydrochloridememantine hydrochlorideCardinal HealthNDACurrent
55154-2667memantine hydrochloridememantine hydrochlorideCardinal HealthNDACurrent
55154-2667memantine hydrochloridememantine hydrochlorideCardinal Health 107, LLCNDACurrent
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