Application 020844

Type
NDA
Sponsor
JANSSEN PHARMS

Application Products#

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

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N020844-001TOPAMAXTOPIRAMATE15MGCAPSULE / ORALABRLD1998-10-26
N020844-002TOPAMAXTOPIRAMATE25MGCAPSULE / ORALABRLD, RS1998-10-26
N020844-003TOPAMAX SPRINKLETOPIRAMATE50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CAPSULE / ORALRLD1998-10-26

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-productTE code
N020844-001AB
N020844-002AB

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.

Product history page 1 of 4 · 123 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02N020844-001TOPAMAX15MGCAPSULE / ORALABRLD1998-10-26011fe1cb6892…
2026-02-19 14:30 UTC2026-02N020844-002TOPAMAX25MGCAPSULE / ORALABRLD, RS1998-10-26011fe1cb6892…
2026-02-19 14:30 UTC2026-02N020844-003TOPAMAX SPRINKLE50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CAPSULE / ORALRLD1998-10-26011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020844-001TOPAMAX15MGCAPSULE / ORALABRLD1998-10-2631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020844-002TOPAMAX25MGCAPSULE / ORALABRLD, RS1998-10-2631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020844-003TOPAMAX SPRINKLE50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CAPSULE / ORALRLD1998-10-2631067a03dcf5…
2025-08-23 18:47 UTC2025-08N020844-001TOPAMAX15MGCAPSULE / ORALABRLD1998-10-266a471c1ec25d…
2025-08-23 18:47 UTC2025-08N020844-002TOPAMAX25MGCAPSULE / ORALABRLD, RS1998-10-266a471c1ec25d…
2025-08-23 18:47 UTC2025-08N020844-003TOPAMAX SPRINKLE50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CAPSULE / ORALRLD1998-10-266a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N020844-001TOPAMAX15MGCAPSULE / ORALABRLD1998-10-26fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N020844-002TOPAMAX25MGCAPSULE / ORALABRLD, RS1998-10-26fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N020844-003TOPAMAX SPRINKLE50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CAPSULE / ORALRLD1998-10-26fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N020844-001TOPAMAX15MGCAPSULE / ORALABRLD1998-10-26b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N020844-002TOPAMAX25MGCAPSULE / ORALABRLD, RS1998-10-26b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N020844-003TOPAMAX SPRINKLE50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CAPSULE / ORALRLD1998-10-26b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N020844-001TOPAMAX15MGCAPSULE / ORALABRLD1998-10-2603ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N020844-002TOPAMAX25MGCAPSULE / ORALABRLD, RS1998-10-2603ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N020844-003TOPAMAX SPRINKLE50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CAPSULE / ORALRLD1998-10-2603ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N020844-001TOPAMAX15MGCAPSULE / ORALABRLD1998-10-262680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N020844-002TOPAMAX25MGCAPSULE / ORALABRLD, RS1998-10-262680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N020844-003TOPAMAX SPRINKLE50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CAPSULE / ORALRLD1998-10-262680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N020844-001TOPAMAX15MGCAPSULE / ORALABRLD1998-10-265bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N020844-002TOPAMAX25MGCAPSULE / ORALABRLD, RS1998-10-265bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N020844-003TOPAMAX SPRINKLE50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CAPSULE / ORALRLD1998-10-265bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N020844-001TOPAMAX15MGCAPSULE / ORALABRLD1998-10-26d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N020844-002TOPAMAX25MGCAPSULE / ORALABRLD, RS1998-10-26d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N020844-003TOPAMAX SPRINKLE50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CAPSULE / ORALRLD1998-10-26d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N020844-001TOPAMAX15MGCAPSULE / ORALABRLD1998-10-26d06236e962d9…
2024-10-29 15:01 UTC2024-10N020844-002TOPAMAX25MGCAPSULE / ORALABRLD, RS1998-10-26d06236e962d9…
2024-10-29 15:01 UTC2024-10N020844-003TOPAMAX SPRINKLE50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CAPSULE / ORALRLD1998-10-26d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N020844-001TOPAMAX15MGCAPSULE / ORALABRLD1998-10-2679d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N020844-002TOPAMAX25MGCAPSULE / ORALABRLD, RS1998-10-2679d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N020844-003TOPAMAX SPRINKLE50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CAPSULE / ORALRLD1998-10-2679d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N020844-001TOPAMAX15MGCAPSULE / ORALABRLD1998-10-26301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N020844-002TOPAMAX25MGCAPSULE / ORALABRLD, RS1998-10-26301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N020844-003TOPAMAX SPRINKLE50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CAPSULE / ORALRLD1998-10-26301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N020844-001TOPAMAX15MGCAPSULE / ORALABRLD1998-10-261e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N020844-002TOPAMAX25MGCAPSULE / ORALABRLD, RS1998-10-261e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N020844-003TOPAMAX SPRINKLE50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CAPSULE / ORALRLD1998-10-261e350fbaab3a…
2024-05-31 18:47 UTC2024-05N020844-001TOPAMAX15MGCAPSULE / ORALABRLD1998-10-268072bd15b7f6…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 82 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02N020844-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02N020844-002AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020844-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020844-002AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08N020844-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08N020844-002AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N020844-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N020844-002AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N020844-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N020844-002AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N020844-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N020844-002AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N020844-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N020844-002AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N020844-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N020844-002AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N020844-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N020844-002AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N020844-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10N020844-002AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N020844-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N020844-002AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N020844-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N020844-002AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N020844-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N020844-002AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05N020844-001AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05N020844-002AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N020844-001AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N020844-002AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N020844-001AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04N020844-002AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N020844-001AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04N020844-002AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N020844-001AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12N020844-002AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03N020844-001AB1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03N020844-002AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N020844-001AB1782e0a99824c…
2021-12-28 21:50 UTC2021-12N020844-002AB1782e0a99824c…

Observed Orange Book patent history#

Captured, Edition, Application-product table
CapturedEditionApplication-productPatentExpirationUse codeCoverage / statusSubmission dateSource SHA-256
2019-12-13 00:20 UTC2019-12N020844-00171255602019-03-01U-76674a2ff9319b5…
2019-12-13 00:20 UTC2019-12N020844-0017125560*PED2019-09-01Pediatric extension74a2ff9319b5…
2019-12-13 00:20 UTC2019-12N020844-00271255602019-03-01U-76674a2ff9319b5…
2019-12-13 00:20 UTC2019-12N020844-0027125560*PED2019-09-01Pediatric extension74a2ff9319b5…
2019-12-13 00:20 UTC2019-12N020844-00371255602019-03-01U-76674a2ff9319b5…
2019-12-13 00:20 UTC2019-12N020844-0037125560*PED2019-09-01Pediatric extension74a2ff9319b5…
2019-12-14 00:12 UTC2019-12N020844-00171255602019-03-01U-7663f01610625f2…
2019-12-14 00:12 UTC2019-12N020844-0017125560*PED2019-09-01Pediatric extension3f01610625f2…
2019-12-14 00:12 UTC2019-12N020844-00271255602019-03-01U-7663f01610625f2…
2019-12-14 00:12 UTC2019-12N020844-0027125560*PED2019-09-01Pediatric extension3f01610625f2…
2019-12-14 00:12 UTC2019-12N020844-00371255602019-03-01U-7663f01610625f2…
2019-12-14 00:12 UTC2019-12N020844-0037125560*PED2019-09-01Pediatric extension3f01610625f2…
2019-09-15 20:21 UTC2019-09N020844-00171255602019-03-01U-766b00525d2431f…
2019-09-15 20:21 UTC2019-09N020844-0017125560*PED2019-09-01Pediatric extensionb00525d2431f…
2019-09-15 20:21 UTC2019-09N020844-00271255602019-03-01U-766b00525d2431f…
2019-09-15 20:21 UTC2019-09N020844-0027125560*PED2019-09-01Pediatric extensionb00525d2431f…
2019-09-15 20:21 UTC2019-09N020844-00371255602019-03-01U-766b00525d2431f…
2019-09-15 20:21 UTC2019-09N020844-0037125560*PED2019-09-01Pediatric extensionb00525d2431f…
2019-07-19 19:46 UTC2019-07N020844-00171255602019-03-01U-766ea99ee380514…
2019-07-19 19:46 UTC2019-07N020844-0017125560*PED2019-09-01Pediatric extensionea99ee380514…
2019-07-19 19:46 UTC2019-07N020844-00271255602019-03-01U-766ea99ee380514…
2019-07-19 19:46 UTC2019-07N020844-0027125560*PED2019-09-01Pediatric extensionea99ee380514…
2019-07-19 19:46 UTC2019-07N020844-00371255602019-03-01U-766ea99ee380514…
2019-07-19 19:46 UTC2019-07N020844-0037125560*PED2019-09-01Pediatric extensionea99ee380514…

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
TopamaxTOPIRAMATEJanssen Pharmaceuticals, Inc.21628112-0c47-11df-95b3-498d55d895932026-03-12Warnings, Adverse reactionsExact identifier
application applno (NDA): 020844
application number: NDA020844
ndc (product): 50458-647
ndc (product): 50458-645

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 14 matching rows.

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