FDA.reportPublic FDA data

Application 021121

Type
NDA
Sponsor
JANSSEN PHARMS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001CONCERTAMETHYLPHENIDATE HYDROCHLORIDETABLET, EXTENDED RELEASE;ORAL18MGYesNo
002CONCERTAMETHYLPHENIDATE HYDROCHLORIDETABLET, EXTENDED RELEASE;ORAL36MGYesNo
003CONCERTAMETHYLPHENIDATE HYDROCHLORIDETABLET, EXTENDED RELEASE;ORAL54MGYesYes
004CONCERTAMETHYLPHENIDATE HYDROCHLORIDETABLET, EXTENDED RELEASE;ORAL27MGYesNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0591-2715methylphenidate hydrochloridemethylphenidate hydrochlorideActavis Pharma, Inc.NDA AUTHORIZED GENERICCurrent
0591-2715methylphenidate hydrochloridemethylphenidate hydrochlorideActavis Pharma, Inc.NDA AUTHORIZED GENERICCurrent
0591-2715methylphenidate hydrochloridemethylphenidate hydrochlorideActavis Pharma, Inc.NDA AUTHORIZED GENERICCurrent
0591-2716methylphenidate hydrochloridemethylphenidate hydrochlorideActavis Pharma, Inc.NDA AUTHORIZED GENERICCurrent
0591-2716methylphenidate hydrochloridemethylphenidate hydrochlorideActavis Pharma, Inc.NDA AUTHORIZED GENERICCurrent
0591-2716methylphenidate hydrochloridemethylphenidate hydrochlorideActavis Pharma, Inc.NDA AUTHORIZED GENERICCurrent
0591-2717methylphenidate hydrochloridemethylphenidate hydrochlorideActavis Pharma, Inc.NDA AUTHORIZED GENERICCurrent
0591-2717methylphenidate hydrochloridemethylphenidate hydrochlorideActavis Pharma, Inc.NDA AUTHORIZED GENERICCurrent
0591-2717methylphenidate hydrochloridemethylphenidate hydrochlorideActavis Pharma, Inc.NDA AUTHORIZED GENERICCurrent
0591-2718methylphenidate hydrochloridemethylphenidate hydrochlorideActavis Pharma, Inc.NDA AUTHORIZED GENERICCurrent
0591-2718methylphenidate hydrochloridemethylphenidate hydrochlorideActavis Pharma, Inc.NDA AUTHORIZED GENERICCurrent
0591-2718methylphenidate hydrochloridemethylphenidate hydrochlorideActavis Pharma, Inc.NDA AUTHORIZED GENERICCurrent
10147-0685methylphenidate Hydrochloridemethylphenidate hydrochloridePatriot Pharmaceuticals, LLC.NDACurrent
10147-0685methylphenidate Hydrochloridemethylphenidate hydrochloridePatriot Pharmaceuticals, LLC.NDACurrent
10147-0685methylphenidate Hydrochloridemethylphenidate hydrochloridePatriot Pharmaceuticals, LLC.NDACurrent
10147-0686methylphenidate Hydrochloridemethylphenidate hydrochloridePatriot Pharmaceuticals, LLC.NDACurrent
10147-0686methylphenidate Hydrochloridemethylphenidate hydrochloridePatriot Pharmaceuticals, LLC.NDACurrent
10147-0686methylphenidate Hydrochloridemethylphenidate hydrochloridePatriot Pharmaceuticals, LLC.NDACurrent
10147-0687methylphenidate Hydrochloridemethylphenidate hydrochloridePatriot Pharmaceuticals, LLC.NDACurrent
10147-0687methylphenidate Hydrochloridemethylphenidate hydrochloridePatriot Pharmaceuticals, LLC.NDACurrent
10147-0687methylphenidate Hydrochloridemethylphenidate hydrochloridePatriot Pharmaceuticals, LLC.NDACurrent
10147-0688methylphenidate Hydrochloridemethylphenidate hydrochloridePatriot Pharmaceuticals, LLC.NDACurrent
10147-0688methylphenidate Hydrochloridemethylphenidate hydrochloridePatriot Pharmaceuticals, LLC.NDACurrent
10147-0688methylphenidate Hydrochloridemethylphenidate hydrochloridePatriot Pharmaceuticals, LLC.NDACurrent
50458-585CONCERTAMethylphenidate hydrochlorideJanssen Pharmaceuticals, Inc.NDACurrent
50458-585CONCERTAMethylphenidate hydrochlorideJanssen Pharmaceuticals, Inc.NDACurrent
50458-585CONCERTAMethylphenidate hydrochlorideJanssen Pharmaceuticals, Inc.NDACurrent
50458-585CONCERTAMethylphenidate hydrochlorideJanssen Pharmaceuticals, Inc.NDACurrent
50458-585CONCERTAMethylphenidate hydrochlorideJanssen Pharmaceuticals, Inc.NDACurrent
50458-586CONCERTAMethylphenidate hydrochlorideJanssen Pharmaceuticals, Inc.NDACurrent
50458-586CONCERTAMethylphenidate hydrochlorideJanssen Pharmaceuticals, Inc.NDACurrent
50458-586CONCERTAMethylphenidate hydrochlorideJanssen Pharmaceuticals, Inc.NDACurrent
50458-586CONCERTAMethylphenidate hydrochlorideJanssen Pharmaceuticals, Inc.NDACurrent
50458-586CONCERTAMethylphenidate hydrochlorideJanssen Pharmaceuticals, Inc.NDACurrent
50458-587CONCERTAMethylphenidate hydrochlorideJanssen Pharmaceuticals, Inc.NDACurrent
50458-587CONCERTAMethylphenidate hydrochlorideJanssen Pharmaceuticals, Inc.NDACurrent
50458-587CONCERTAMethylphenidate hydrochlorideJanssen Pharmaceuticals, Inc.NDACurrent
50458-587CONCERTAMethylphenidate hydrochlorideJanssen Pharmaceuticals, Inc.NDACurrent
50458-587CONCERTAMethylphenidate hydrochlorideJanssen Pharmaceuticals, Inc.NDACurrent
50458-588CONCERTAMethylphenidate hydrochlorideJanssen Pharmaceuticals, Inc.NDACurrent
50458-588CONCERTAMethylphenidate hydrochlorideJanssen Pharmaceuticals, Inc.NDACurrent
50458-588CONCERTAMethylphenidate hydrochlorideJanssen Pharmaceuticals, Inc.NDACurrent
50458-588CONCERTAMethylphenidate hydrochlorideJanssen Pharmaceuticals, Inc.NDACurrent
50458-588CONCERTAMethylphenidate hydrochlorideJanssen Pharmaceuticals, Inc.NDACurrent
68084-816methylphenidate hydrochloridemethylphenidate hydrochlorideAmerican Health PackagingNDA AUTHORIZED GENERICCurrent
68084-816methylphenidate hydrochloridemethylphenidate hydrochlorideAmerican Health PackagingNDA AUTHORIZED GENERICCurrent
68084-829methylphenidate hydrochloridemethylphenidate hydrochlorideAmerican Health PackagingNDA AUTHORIZED GENERICCurrent
68084-829methylphenidate hydrochloridemethylphenidate hydrochlorideAmerican Health PackagingNDA AUTHORIZED GENERICCurrent
68084-833methylphenidate hydrochloridemethylphenidate hydrochlorideAmerican Health PackagingNDA AUTHORIZED GENERICCurrent
68084-833methylphenidate hydrochloridemethylphenidate hydrochlorideAmerican Health PackagingNDA AUTHORIZED GENERICCurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
85721SUPPL 2026-04-20
85675SUPPL 2026-04-13
84904SUPPL 2026-02-03
84903SUPPL 2026-02-03
84902SUPPL 2026-02-03
84901SUPPL 2026-02-03
83497SUPPL 2025-09-25
83437SUPPL 2025-09-25
75821SUPPL 2023-10-17
75755SUPPL 2023-10-16
67959SUPPL2021-06-29
67958SUPPL2021-06-29
67947SUPPL2021-06-29
48421SUPPL2017-05-17
46794SUPPL2017-01-11
46793SUPPL2017-01-11
46718SUPPL2017-01-06
36160SUPPL2015-04-22
26828SUPPL2015-04-21
14438SUPPL2013-12-17
26827SUPPL2013-12-16
36159SUPPL2013-06-18
4383SUPPL2013-06-14
14437SUPPL2013-05-09
26826SUPPL2013-05-07
21462SUPPL2011-09-22
36158SUPPL2010-12-01
14436SUPPL2010-12-01
26825SUPPL2010-11-30
4382SUPPL2010-11-30
4381SUPPL2010-01-25
14435SUPPL2009-11-23
26824SUPPL2008-07-01
4380SUPPL2008-07-01
14434SUPPL2008-06-30
14433SUPPL2008-06-30
41963SUPPL2007-06-22
44099ORIG2007-05-10
26823SUPPL2007-05-09
14432SUPPL2007-05-07
26822SUPPL2006-09-18
26821SUPPL2006-09-18
36157SUPPL2006-09-12
36156SUPPL2006-09-12
14431SUPPL2004-11-01
26820SUPPL2004-10-29
26819SUPPL2002-04-01
21461ORIG2000-08-01
14430ORIG2000-08-01
4379ORIG2000-08-01
52036SUPPL1900-01-01
52035SUPPL1900-01-01
52034SUPPL1900-01-01
52033SUPPL1900-01-01
52032SUPPL1900-01-01