FDA.reportPublic FDA data

Application 020844

Type
NDA
Sponsor
JANSSEN PHARMS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001TOPAMAXTOPIRAMATECAPSULE;ORAL15MGYesNo
002TOPAMAXTOPIRAMATECAPSULE;ORAL25MGYesYes
003TOPAMAX SPRINKLETOPIRAMATECAPSULE;ORAL50MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
50458-645TopamaxtopiramateJanssen Pharmaceuticals, Inc.NDACurrent
50458-645TopamaxtopiramateJanssen Pharmaceuticals, Inc.NDACurrent
50458-645TopamaxtopiramateJanssen Pharmaceuticals, Inc.NDACurrent
50458-645TopamaxtopiramateJanssen Pharmaceuticals, Inc.NDACurrent
50458-645TopamaxtopiramateJanssen Pharmaceuticals, Inc.NDACurrent
50458-645TopamaxtopiramateJanssen Pharmaceuticals, Inc.NDACurrent
50458-645TopamaxtopiramateJanssen Pharmaceuticals, Inc.NDACurrent
50458-647TopamaxtopiramateJanssen Pharmaceuticals, Inc.NDACurrent
50458-647TopamaxtopiramateJanssen Pharmaceuticals, Inc.NDACurrent
50458-647TopamaxtopiramateJanssen Pharmaceuticals, Inc.NDACurrent
50458-647TopamaxtopiramateJanssen Pharmaceuticals, Inc.NDACurrent
50458-647TopamaxtopiramateJanssen Pharmaceuticals, Inc.NDACurrent
50458-647TopamaxtopiramateJanssen Pharmaceuticals, Inc.NDACurrent
50458-647TopamaxtopiramateJanssen Pharmaceuticals, Inc.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
85327SUPPL 2026-03-12
85295SUPPL 2026-03-09
85351SUPPL 2026-03-06
81589SUPPL 2025-03-17
81557SUPPL 2025-03-14
74176SUPPL 2023-05-04
74175SUPPL 2023-05-04
74155SUPPL 2023-05-02
72440SUPPL2022-10-21
69915SUPPL2022-01-19
69914SUPPL2022-01-19
69903SUPPL2022-01-19
69902SUPPL2022-01-19
68003SUPPL2021-07-01
68001SUPPL2021-07-01
68000SUPPL2021-07-01
63472SUPPL2020-06-09
63471SUPPL2020-06-09
63462SUPPL2020-06-09
58554SUPPL2019-05-03
58542SUPPL2019-05-03
58539SUPPL2019-05-03
57104SUPPL2019-01-02
57058SUPPL2018-12-30
57045SUPPL2018-12-28
54730SUPPL2018-06-29
54646SUPPL2018-06-21
48410SUPPL2017-05-17
48379SUPPL2017-05-16
26043SUPPL2014-12-19
13605SUPPL2014-12-19
13604SUPPL2014-10-23
3565SUPPL2014-10-23
26042SUPPL2014-04-02
13602SUPPL2014-04-01
13603SUPPL2014-01-31
3564SUPPL2014-01-30
3563SUPPL2012-11-01
35504SUPPL2012-10-29
3562SUPPL2011-07-19
13601SUPPL2011-07-18
3561SUPPL2011-03-08
13600SUPPL2011-03-04
35502SUPPL2010-01-04
35501SUPPL2010-01-04
35499SUPPL2010-01-04
13598SUPPL2010-01-04
26040SUPPL2009-12-30
26039SUPPL2009-12-30
3558SUPPL2009-12-30
3550SUPPL2009-12-30
35503SUPPL2009-05-12
13599SUPPL2009-05-12
26041SUPPL2009-05-04
3560SUPPL2009-05-04
13597SUPPL2009-04-28
3559SUPPL2009-04-27
26038SUPPL2006-10-23
26037SUPPL2005-07-08
26034SUPPL2005-07-08
13596SUPPL2005-07-05
13594SUPPL2005-07-05
21013ORIG2004-09-15
21015SUPPL2004-09-08
26035SUPPL2004-08-12
13595SUPPL2004-08-12
3557SUPPL2004-08-12
26032SUPPL2004-06-28
35500SUPPL2003-12-29
13593SUPPL2003-12-29
13592SUPPL2003-12-29
3554SUPPL2003-12-19
3553SUPPL2003-12-19
26036SUPPL2003-07-30
3556SUPPL2003-07-30
3555SUPPL2003-06-22
3551SUPPL2003-06-08
3552SUPPL2002-11-26
35498SUPPL2001-08-28
26033SUPPL2001-08-28
41758SUPPL2000-07-03
21014SUPPL2000-07-03
13591SUPPL1999-07-23
3549SUPPL1999-07-23
13590ORIG1998-10-26
3548ORIG1998-10-26
53032ORIG1900-01-01
53031ORIG1900-01-01