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 44.

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 · 264 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-10-15 13:18:302026-09N020505-001TOPAMAX100MGTABLET / ORALABRLD, RS1996-12-24c2088c7a36db…
2026-10-15 13:18:302026-09N020505-002TOPAMAX200MGTABLET / ORALABRLD1996-12-24c2088c7a36db…
2026-10-15 13:18:302026-09N020505-003TOPAMAX300MGTABLET / ORAL1996-12-24c2088c7a36db…
2026-10-15 13:18:302026-09N020505-004TOPAMAX25MGTABLET / ORALABRLD1996-12-24c2088c7a36db…
2026-10-15 13:18:302026-09N020505-005TOPAMAX50MGTABLET / ORALABRLD1996-12-24c2088c7a36db…
2026-10-15 13:18:302026-09N020505-006TOPAMAX400MGTABLET / ORAL1996-12-24c2088c7a36db…
2026-09-14 22:38:342026-08N020505-001TOPAMAX100MGTABLET / ORALABRLD, RS1996-12-2484e616aacf4f…
2026-09-14 22:38:342026-08N020505-002TOPAMAX200MGTABLET / ORALABRLD1996-12-2484e616aacf4f…
2026-09-14 22:38:342026-08N020505-003TOPAMAX300MGTABLET / ORAL1996-12-2484e616aacf4f…
2026-09-14 22:38:342026-08N020505-004TOPAMAX25MGTABLET / ORALABRLD1996-12-2484e616aacf4f…
2026-09-14 22:38:342026-08N020505-005TOPAMAX50MGTABLET / ORALABRLD1996-12-2484e616aacf4f…
2026-09-14 22:38:342026-08N020505-006TOPAMAX400MGTABLET / ORAL1996-12-2484e616aacf4f…
2026-08-18 06:07:402026-07N020505-001TOPAMAX100MGTABLET / ORALABRLD, RS1996-12-24caaa826d4ba7…
2026-08-18 06:07:402026-07N020505-002TOPAMAX200MGTABLET / ORALABRLD1996-12-24caaa826d4ba7…
2026-08-18 06:07:402026-07N020505-003TOPAMAX300MGTABLET / ORAL1996-12-24caaa826d4ba7…
2026-08-18 06:07:402026-07N020505-004TOPAMAX25MGTABLET / ORALABRLD1996-12-24caaa826d4ba7…
2026-08-18 06:07:402026-07N020505-005TOPAMAX50MGTABLET / ORALABRLD1996-12-24caaa826d4ba7…
2026-08-18 06:07:402026-07N020505-006TOPAMAX400MGTABLET / ORAL1996-12-24caaa826d4ba7…
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…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 5 · 176 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-10-15 13:18:302026-09N020505-001AB1c2088c7a36db…
2026-10-15 13:18:302026-09N020505-002AB1c2088c7a36db…
2026-10-15 13:18:302026-09N020505-004AB1c2088c7a36db…
2026-10-15 13:18:302026-09N020505-005AB1c2088c7a36db…
2026-09-14 22:38:342026-08N020505-001AB184e616aacf4f…
2026-09-14 22:38:342026-08N020505-002AB184e616aacf4f…
2026-09-14 22:38:342026-08N020505-004AB184e616aacf4f…
2026-09-14 22:38:342026-08N020505-005AB184e616aacf4f…
2026-08-18 06:07:402026-07N020505-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07N020505-002AB1caaa826d4ba7…
2026-08-18 06:07:402026-07N020505-004AB1caaa826d4ba7…
2026-08-18 06:07:402026-07N020505-005AB1caaa826d4ba7…
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…

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 5 of 8 · 143 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
topiramateTOPIRAMATEMajor Pharmaceuticals6fb00bd8-c49e-46ef-9d6b-1b602e1d11d82025-08-25Warnings, Adverse reactionsName fallback
generic name: TOPIRAMATE
topiramateTOPIRAMATEA-S Medication Solutions674c2c2e-014a-43a1-91a7-7214ffc4b1d72025-08-13Warnings, Adverse reactionsName fallback
generic name: TOPIRAMATE
TopiramateTOPIRAMATENuCare Pharmaceuticals, Inc.490f109f-30cb-0790-e054-00144ff88e882025-07-24Warnings, Adverse reactionsName fallback
generic name: TOPIRAMATE
TopiramateTOPIRAMATEPD-Rx Pharmaceuticals, Inc.9e516204-8f39-43c9-9f7e-d9777586f3212025-07-15Warnings, Adverse reactionsName fallback
generic name: TOPIRAMATE
TopiramateTOPIRAMATEPD-Rx Pharmaceuticals, Inc.e39d2549-b489-426d-b576-741537e112e72025-07-15Warnings, Adverse reactionsName fallback
generic name: TOPIRAMATE
TOPIRAMATETOPIRAMATEXLCare Pharmaceuticals, Inc.546103e1-ea6e-466b-b0de-b1ff8c4945122025-07-02Warnings, Adverse reactionsName fallback
generic name: TOPIRAMATE
TopiramateTOPIRAMATEA-S Medication Solutionsf16b14a2-297f-4adb-8d7a-5f43785faef72025-06-09Warnings, Adverse reactionsName fallback
generic name: TOPIRAMATE
TOPIRAMATETOPIRAMATECamber Pharmaceuticals, Inc.cefbc5f4-ef5f-4732-ab96-a69a183f0b6b2025-05-22Warnings, Adverse reactionsName fallback
generic name: TOPIRAMATE
topiramateTOPIRAMATEBryant Ranch Prepack49701840-5a32-4ac1-8b07-5c61decacb952025-05-01Warnings, Adverse reactionsName fallback
generic name: TOPIRAMATE
topiramateTOPIRAMATEBryant Ranch Prepackbf732c34-9078-496a-8093-f68594e76fcb2025-05-01Warnings, Adverse reactionsName fallback
generic name: TOPIRAMATE
topiramateTOPIRAMATEBryant Ranch Prepack02cac021-e135-483f-bb5d-f3696eef06822025-05-01Warnings, Adverse reactionsName fallback
generic name: TOPIRAMATE
topiramateTOPIRAMATEBryant Ranch Prepackc320999e-b940-44d8-bf31-2fb78835ac2d2025-05-01Warnings, Adverse reactionsName fallback
generic name: TOPIRAMATE
TopiramateTOPIRAMATEA-S Medication Solutionsea0bcab1-cfe1-491c-875e-8c865449557e2025-04-29Warnings, Adverse reactionsName fallback
generic name: TOPIRAMATE
topiramateTOPIRAMATEBryant Ranch Prepack073d075d-d019-4834-b55d-9b95879149752025-04-16Warnings, Adverse reactionsName fallback
generic name: TOPIRAMATE
TopiramateTOPIRAMATECipla USA Inc.4087eb3c-96e9-4d0a-b80b-663e1c86d2562025-04-14Warnings, Adverse reactionsName fallback
generic name: TOPIRAMATE
TopiramateTOPIRAMATEEXELAN PHARMACEUTICALS INC.690baf58-1ec9-463e-99b7-d601362ea56b2025-04-14Warnings, Adverse reactionsName fallback
generic name: TOPIRAMATE
TopiramateTOPIRAMATECipla USA Inc.ca4ec248-285d-4066-8f89-5ed0c538c4c92025-04-09Warnings, Adverse reactionsName fallback
generic name: TOPIRAMATE
topiramateTOPIRAMATEAdvanced Rx of Tennessee, LLC30ca2fce-4e4c-439e-e063-6294a90af0762025-03-20Warnings, Adverse reactionsName fallback
generic name: TOPIRAMATE
topiramateTOPIRAMATEPreferred Pharmaceuticals Inc.bbf0f882-1dcc-415d-82bb-acc64f4dc2bc2025-02-21Warnings, Adverse reactionsName fallback
generic name: TOPIRAMATE
topiramateTOPIRAMATEPreferred Pharmaceuticals Inc.288d6b40-8c87-4f16-85a7-86166b5ac77f2025-02-14Warnings, Adverse reactionsName fallback
generic name: TOPIRAMATE

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

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