FDA.reportPublic FDA data

Application 206028

Type
ANDA
Sponsor
LUPIN LTD

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001MEMANTINE HYDROCHLORIDEMEMANTINE HYDROCHLORIDECAPSULE, EXTENDED RELEASE;ORAL7MGNoNo
002MEMANTINE HYDROCHLORIDEMEMANTINE HYDROCHLORIDECAPSULE, EXTENDED RELEASE;ORAL14MGNoNo
003MEMANTINE HYDROCHLORIDEMEMANTINE HYDROCHLORIDECAPSULE, EXTENDED RELEASE;ORAL21MGNoNo
004MEMANTINE HYDROCHLORIDEMEMANTINE HYDROCHLORIDECAPSULE, EXTENDED RELEASE;ORAL28MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0615-8264memantine hydrochloridememantine hydrochlorideNCS HealthCare of KY, Inc dba Vangard LabsANDACurrent
0904-6734memantine hydrochloridememantine hydrochlorideMajor PharmaceuticalsANDACurrent
0904-6735memantine hydrochloridememantine hydrochlorideMajor PharmaceuticalsANDACurrent
0904-6735memantine hydrochloridememantine hydrochlorideMajor PharmaceuticalsANDACurrent
0904-6736memantine hydrochloridememantine hydrochlorideMajor PharmaceuticalsANDACurrent
0904-6736memantine hydrochloridememantine hydrochlorideMajor PharmaceuticalsANDACurrent
0904-6737memantine hydrochloridememantine hydrochlorideMajor PharmaceuticalsANDACurrent
68180-246memantine hydrochloridememantine hydrochlorideLupin Pharmaceuticals, Inc.ANDACurrent
68180-246memantine hydrochloridememantine hydrochlorideLupin Pharmaceuticals, Inc.ANDACurrent
68180-246memantine hydrochloridememantine hydrochlorideLupin Pharmaceuticals, Inc.ANDACurrent
68180-246memantine hydrochloridememantine hydrochlorideLupin Pharmaceuticals, Inc.ANDACurrent
68180-247memantine hydrochloridememantine hydrochlorideLupin Pharmaceuticals, Inc.ANDACurrent
68180-247memantine hydrochloridememantine hydrochlorideLupin Pharmaceuticals, Inc.ANDACurrent
68180-247memantine hydrochloridememantine hydrochlorideLupin Pharmaceuticals, Inc.ANDACurrent
68180-247memantine hydrochloridememantine hydrochlorideLupin Pharmaceuticals, Inc.ANDACurrent
68180-248memantine hydrochloridememantine hydrochlorideLupin Pharmaceuticals, Inc.ANDACurrent
68180-248memantine hydrochloridememantine hydrochlorideLupin Pharmaceuticals, Inc.ANDACurrent
68180-248memantine hydrochloridememantine hydrochlorideLupin Pharmaceuticals, Inc.ANDACurrent
68180-248memantine hydrochloridememantine hydrochlorideLupin Pharmaceuticals, Inc.ANDACurrent
68180-249memantine hydrochloridememantine hydrochlorideLupin Pharmaceuticals, Inc.ANDACurrent
68180-249memantine hydrochloridememantine hydrochlorideLupin Pharmaceuticals, Inc.ANDACurrent
68180-249memantine hydrochloridememantine hydrochlorideLupin Pharmaceuticals, Inc.ANDACurrent
68180-249memantine hydrochloridememantine hydrochlorideLupin Pharmaceuticals, Inc.ANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
45605ORIG2016-10-11
45445ORIG2016-10-03