FDA.reportPublic FDA data

Application 020505

Type
NDA
Sponsor
JANSSEN PHARMS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001TOPAMAXTOPIRAMATETABLET;ORAL100MGYesYes
002TOPAMAXTOPIRAMATETABLET;ORAL200MGYesNo
003TOPAMAXTOPIRAMATETABLET;ORAL300MGNoNo
004TOPAMAXTOPIRAMATETABLET;ORAL25MGYesNo
005TOPAMAXTOPIRAMATETABLET;ORAL50MGYesNo
006TOPAMAXTOPIRAMATETABLET;ORAL400MGNoNo

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

Orange Book products#

Current product rows page 1 of 1 · 6 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N020505-001TOPAMAXTOPIRAMATE100MGTABLET / ORALABRLD, RS1996-12-24
N020505-002TOPAMAXTOPIRAMATE200MGTABLET / ORALABRLD1996-12-24
N020505-003TOPAMAXTOPIRAMATE300MGTABLET / ORAL1996-12-24
N020505-004TOPAMAXTOPIRAMATE25MGTABLET / ORALABRLD1996-12-24
N020505-005TOPAMAXTOPIRAMATE50MGTABLET / ORALABRLD1996-12-24
N020505-006TOPAMAXTOPIRAMATE400MGTABLET / ORAL1996-12-24

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 4 matching rows.

Application-product, TE code table
Application-productTE code
N020505-001AB
N020505-002AB
N020505-004AB
N020505-005AB

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 7 · 246 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02N020505-001TOPAMAX100MGTABLET / ORALABRLD, RS1996-12-24011fe1cb6892…
2026-02-19 14:30 UTC2026-02N020505-002TOPAMAX200MGTABLET / ORALABRLD1996-12-24011fe1cb6892…
2026-02-19 14:30 UTC2026-02N020505-003TOPAMAX300MGTABLET / ORAL1996-12-24011fe1cb6892…
2026-02-19 14:30 UTC2026-02N020505-004TOPAMAX25MGTABLET / ORALABRLD1996-12-24011fe1cb6892…
2026-02-19 14:30 UTC2026-02N020505-005TOPAMAX50MGTABLET / ORALABRLD1996-12-24011fe1cb6892…
2026-02-19 14:30 UTC2026-02N020505-006TOPAMAX400MGTABLET / ORAL1996-12-24011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020505-001TOPAMAX100MGTABLET / ORALABRLD, RS1996-12-2431067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020505-002TOPAMAX200MGTABLET / ORALABRLD1996-12-2431067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020505-003TOPAMAX300MGTABLET / ORAL1996-12-2431067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020505-004TOPAMAX25MGTABLET / ORALABRLD1996-12-2431067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020505-005TOPAMAX50MGTABLET / ORALABRLD1996-12-2431067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020505-006TOPAMAX400MGTABLET / ORAL1996-12-2431067a03dcf5…
2025-08-23 18:47 UTC2025-08N020505-001TOPAMAX100MGTABLET / ORALABRLD, RS1996-12-246a471c1ec25d…
2025-08-23 18:47 UTC2025-08N020505-002TOPAMAX200MGTABLET / ORALABRLD1996-12-246a471c1ec25d…
2025-08-23 18:47 UTC2025-08N020505-003TOPAMAX300MGTABLET / ORAL1996-12-246a471c1ec25d…
2025-08-23 18:47 UTC2025-08N020505-004TOPAMAX25MGTABLET / ORALABRLD1996-12-246a471c1ec25d…
2025-08-23 18:47 UTC2025-08N020505-005TOPAMAX50MGTABLET / ORALABRLD1996-12-246a471c1ec25d…
2025-08-23 18:47 UTC2025-08N020505-006TOPAMAX400MGTABLET / ORAL1996-12-246a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N020505-001TOPAMAX100MGTABLET / ORALABRLD, RS1996-12-24fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N020505-002TOPAMAX200MGTABLET / ORALABRLD1996-12-24fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N020505-003TOPAMAX300MGTABLET / ORAL1996-12-24fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N020505-004TOPAMAX25MGTABLET / ORALABRLD1996-12-24fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N020505-005TOPAMAX50MGTABLET / ORALABRLD1996-12-24fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N020505-006TOPAMAX400MGTABLET / ORAL1996-12-24fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N020505-001TOPAMAX100MGTABLET / ORALABRLD, RS1996-12-24b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N020505-002TOPAMAX200MGTABLET / ORALABRLD1996-12-24b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N020505-003TOPAMAX300MGTABLET / ORAL1996-12-24b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N020505-004TOPAMAX25MGTABLET / ORALABRLD1996-12-24b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N020505-005TOPAMAX50MGTABLET / ORALABRLD1996-12-24b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N020505-006TOPAMAX400MGTABLET / ORAL1996-12-24b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N020505-001TOPAMAX100MGTABLET / ORALABRLD, RS1996-12-2403ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N020505-002TOPAMAX200MGTABLET / ORALABRLD1996-12-2403ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N020505-003TOPAMAX300MGTABLET / ORAL1996-12-2403ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N020505-004TOPAMAX25MGTABLET / ORALABRLD1996-12-2403ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N020505-005TOPAMAX50MGTABLET / ORALABRLD1996-12-2403ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N020505-006TOPAMAX400MGTABLET / ORAL1996-12-2403ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N020505-001TOPAMAX100MGTABLET / ORALABRLD, RS1996-12-242680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N020505-002TOPAMAX200MGTABLET / ORALABRLD1996-12-242680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N020505-003TOPAMAX300MGTABLET / ORAL1996-12-242680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N020505-004TOPAMAX25MGTABLET / ORALABRLD1996-12-242680178bc6a6…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 5 · 164 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02N020505-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02N020505-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02N020505-004AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02N020505-005AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020505-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020505-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020505-004AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020505-005AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08N020505-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08N020505-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08N020505-004AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08N020505-005AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N020505-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N020505-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N020505-004AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N020505-005AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N020505-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N020505-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N020505-004AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N020505-005AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N020505-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N020505-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N020505-004AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N020505-005AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N020505-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N020505-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N020505-004AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N020505-005AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N020505-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N020505-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N020505-004AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N020505-005AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N020505-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N020505-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N020505-004AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N020505-005AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N020505-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10N020505-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10N020505-004AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10N020505-005AB1d06236e962d9…

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): 020505
application number: NDA020505
ndc (product): 50458-642
ndc (product): 50458-639
ndc (product): 50458-641
ndc (product): 50458-640

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 43 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
21695-128TopamaxtopiramateRebel Distributors CorpNDACurrent
21695-129TopamaxtopiramateRebel Distributors CorpNDACurrent
21695-130TopamaxtopiramateRebel Distributors CorpNDACurrent
50458-639TopamaxtopiramateJanssen Pharmaceuticals, Inc.NDACurrent
50458-639TopamaxtopiramateJanssen Pharmaceuticals, Inc.NDACurrent
50458-639TopamaxtopiramateJanssen Pharmaceuticals, Inc.NDACurrent
50458-639TopamaxtopiramateJanssen Pharmaceuticals, Inc.NDACurrent
50458-639TopamaxtopiramateJanssen Pharmaceuticals, Inc.NDACurrent
50458-639TopamaxtopiramateJanssen Pharmaceuticals, Inc.NDACurrent
50458-639TopamaxtopiramateJanssen Pharmaceuticals, Inc.NDACurrent
50458-640TopamaxtopiramateJanssen Pharmaceuticals, Inc.NDACurrent
50458-640TopamaxtopiramateJanssen Pharmaceuticals, Inc.NDACurrent
50458-640TopamaxtopiramateJanssen Pharmaceuticals, Inc.NDACurrent
50458-640TopamaxtopiramateJanssen Pharmaceuticals, Inc.NDACurrent
50458-640TopamaxtopiramateJanssen Pharmaceuticals, Inc.NDACurrent
50458-640TopamaxtopiramateJanssen Pharmaceuticals, Inc.NDACurrent
50458-640TopamaxtopiramateJanssen Pharmaceuticals, Inc.NDACurrent
50458-641TopamaxtopiramateJanssen Pharmaceuticals, Inc.NDACurrent
50458-641TopamaxtopiramateJanssen Pharmaceuticals, Inc.NDACurrent
50458-641TopamaxtopiramateJanssen Pharmaceuticals, Inc.NDACurrent
50458-641TopamaxtopiramateJanssen Pharmaceuticals, Inc.NDACurrent
50458-641TopamaxtopiramateJanssen Pharmaceuticals, Inc.NDACurrent
50458-641TopamaxtopiramateJanssen Pharmaceuticals, Inc.NDACurrent
50458-641TopamaxtopiramateJanssen Pharmaceuticals, Inc.NDACurrent
50458-642TopamaxtopiramateJanssen Pharmaceuticals, Inc.NDACurrent
50458-642TopamaxtopiramateJanssen Pharmaceuticals, Inc.NDACurrent
50458-642TopamaxtopiramateJanssen Pharmaceuticals, Inc.NDACurrent
50458-642TopamaxtopiramateJanssen Pharmaceuticals, Inc.NDACurrent
50458-642TopamaxtopiramateJanssen Pharmaceuticals, Inc.NDACurrent
50458-642TopamaxtopiramateJanssen Pharmaceuticals, Inc.NDACurrent
50458-642TopamaxtopiramateJanssen Pharmaceuticals, Inc.NDACurrent
55289-433TopamaxtopiramatePD-Rx Pharmaceuticals, Inc.NDACurrent
55289-433TopamaxtopiramatePD-Rx Pharmaceuticals, Inc.NDACurrent
55289-433TopamaxtopiramatePD-Rx Pharmaceuticals, Inc.NDACurrent
55289-433TopamaxtopiramatePD-Rx Pharmaceuticals, Inc.NDACurrent
55289-433TopamaxtopiramatePD-Rx Pharmaceuticals, Inc.NDACurrent
70518-1393TopamaxtopiramateREMEDYREPACK INC.NDACurrent
70518-1393TopamaxtopiramateREMEDYREPACK INC.NDACurrent
70518-2165TopamaxtopiramateREMEDYREPACK INC.NDACurrent
70518-2753TopamaxtopiramateREMEDYREPACK INC.NDACurrent
70518-2753TopamaxtopiramateREMEDYREPACK INC.NDACurrent
70518-2753TopamaxtopiramateREMEDYREPACK INC.NDACurrent
70518-2753TopamaxtopiramateREMEDYREPACK INC.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
85350SUPPL 2026-03-12
85326SUPPL 2026-03-12
85294SUPPL 2026-03-09
81587SUPPL 2025-03-17
81556SUPPL 2025-03-14
74174SUPPL 2023-05-04
74167SUPPL 2023-05-04
72461SUPPL2022-10-24
72439SUPPL2022-10-21
69913SUPPL2022-01-19
69912SUPPL2022-01-19
69901SUPPL2022-01-19
68018SUPPL2021-07-07
68002SUPPL2021-07-01
67999SUPPL2021-07-01
63470SUPPL2020-06-09
63469SUPPL2020-06-09
63461SUPPL2020-06-09
58553SUPPL2019-05-03
58541SUPPL2019-05-03
58540SUPPL2019-05-03
57103SUPPL2019-01-02
57057SUPPL2018-12-30
57044SUPPL2018-12-28
54689SUPPL2018-06-26
54647SUPPL2018-06-21
48409SUPPL2017-05-17
48381SUPPL2017-05-16
12654SUPPL2014-12-19
2626SUPPL2014-12-19
34736SUPPL2014-10-23
2625SUPPL2014-10-23
25072SUPPL2014-04-02
34735SUPPL2014-04-01
12653SUPPL2014-01-31
25073SUPPL2014-01-30
2624SUPPL2012-11-01
34734SUPPL2012-10-29
20687SUPPL2012-02-28
2623SUPPL2011-07-19
12651SUPPL2011-07-18
25071SUPPL2011-03-08
25070SUPPL2011-03-08
12652SUPPL2011-03-04
12650SUPPL2011-03-04
34732SUPPL2010-01-04
34730SUPPL2010-01-04
34726SUPPL2010-01-04
12648SUPPL2010-01-04
25068SUPPL2009-12-30
25067SUPPL2009-12-30
2621SUPPL2009-12-30
2613SUPPL2009-12-30
34733SUPPL2009-05-12
12649SUPPL2009-05-12
25069SUPPL2009-05-04
2622SUPPL2009-05-04
34731SUPPL2009-04-28
25066SUPPL2006-10-23
25065SUPPL2005-07-08
25064SUPPL2005-07-08
34729SUPPL2005-07-05
34727SUPPL2005-07-05
20686ORIG2004-09-10
41401SUPPL2004-09-08
12647SUPPL2004-08-12
12646SUPPL2004-08-12
2620SUPPL2004-08-12
2618SUPPL2004-08-12
2612SUPPL2004-06-28
34728SUPPL2003-12-29
34725SUPPL2003-12-29
12645SUPPL2003-12-29
2615SUPPL2003-12-19
2614SUPPL2003-12-19
2616SUPPL2003-06-22
25062SUPPL2003-06-08
2619SUPPL2003-05-29
2617SUPPL2003-05-29
25063SUPPL2002-12-09
34723SUPPL2001-08-28
25060SUPPL2001-08-28
41402SUPPL2000-07-03
41400SUPPL2000-07-03
34724SUPPL1999-10-01
25061SUPPL1999-10-01
34722SUPPL1999-07-23
25059SUPPL1999-07-23
53030SUPPL1900-01-01
53029SUPPL1900-01-01
52377ORIG1900-01-01
52376ORIG1900-01-01
51495ORIG1900-01-01
51494ORIG1900-01-01