Home Applications 020844 Application 020844
Type NDA
Sponsor JANSSEN PHARMS Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 TOPAMAX TOPIRAMATE CAPSULE;ORAL 15MG Yes No 002 TOPAMAX TOPIRAMATE CAPSULE;ORAL 25MG Yes Yes 003 TOPAMAX SPRINKLE TOPIRAMATE CAPSULE;ORAL 50MG No No
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-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N020844-001 TOPAMAX TOPIRAMATE 15MG CAPSULE / ORAL AB RLD 1998-10-26 N020844-002 TOPAMAX TOPIRAMATE 25MG CAPSULE / ORAL AB RLD, RS 1998-10-26 N020844-003 TOPAMAX SPRINKLE TOPIRAMATE 50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** CAPSULE / ORAL RLD 1998-10-26
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 2 matching rows.
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 Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-02-19 14:30 UTC 2026-02 N020844-001 TOPAMAX 15MG CAPSULE / ORAL AB RLD 1998-10-26 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N020844-002 TOPAMAX 25MG CAPSULE / ORAL AB RLD, RS 1998-10-26 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N020844-003 TOPAMAX SPRINKLE 50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** CAPSULE / ORAL RLD 1998-10-26 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N020844-001 TOPAMAX 15MG CAPSULE / ORAL AB RLD 1998-10-26 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N020844-002 TOPAMAX 25MG CAPSULE / ORAL AB RLD, RS 1998-10-26 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N020844-003 TOPAMAX SPRINKLE 50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** CAPSULE / ORAL RLD 1998-10-26 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N020844-001 TOPAMAX 15MG CAPSULE / ORAL AB RLD 1998-10-26 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N020844-002 TOPAMAX 25MG CAPSULE / ORAL AB RLD, RS 1998-10-26 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N020844-003 TOPAMAX SPRINKLE 50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** CAPSULE / ORAL RLD 1998-10-26 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N020844-001 TOPAMAX 15MG CAPSULE / ORAL AB RLD 1998-10-26 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N020844-002 TOPAMAX 25MG CAPSULE / ORAL AB RLD, RS 1998-10-26 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N020844-003 TOPAMAX SPRINKLE 50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** CAPSULE / ORAL RLD 1998-10-26 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N020844-001 TOPAMAX 15MG CAPSULE / ORAL AB RLD 1998-10-26 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N020844-002 TOPAMAX 25MG CAPSULE / ORAL AB RLD, RS 1998-10-26 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N020844-003 TOPAMAX SPRINKLE 50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** CAPSULE / ORAL RLD 1998-10-26 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N020844-001 TOPAMAX 15MG CAPSULE / ORAL AB RLD 1998-10-26 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N020844-002 TOPAMAX 25MG CAPSULE / ORAL AB RLD, RS 1998-10-26 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N020844-003 TOPAMAX SPRINKLE 50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** CAPSULE / ORAL RLD 1998-10-26 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N020844-001 TOPAMAX 15MG CAPSULE / ORAL AB RLD 1998-10-26 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N020844-002 TOPAMAX 25MG CAPSULE / ORAL AB RLD, RS 1998-10-26 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N020844-003 TOPAMAX SPRINKLE 50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** CAPSULE / ORAL RLD 1998-10-26 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N020844-001 TOPAMAX 15MG CAPSULE / ORAL AB RLD 1998-10-26 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N020844-002 TOPAMAX 25MG CAPSULE / ORAL AB RLD, RS 1998-10-26 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N020844-003 TOPAMAX SPRINKLE 50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** CAPSULE / ORAL RLD 1998-10-26 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N020844-001 TOPAMAX 15MG CAPSULE / ORAL AB RLD 1998-10-26 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N020844-002 TOPAMAX 25MG CAPSULE / ORAL AB RLD, RS 1998-10-26 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N020844-003 TOPAMAX SPRINKLE 50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** CAPSULE / ORAL RLD 1998-10-26 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N020844-001 TOPAMAX 15MG CAPSULE / ORAL AB RLD 1998-10-26 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N020844-002 TOPAMAX 25MG CAPSULE / ORAL AB RLD, RS 1998-10-26 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N020844-003 TOPAMAX SPRINKLE 50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** CAPSULE / ORAL RLD 1998-10-26 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N020844-001 TOPAMAX 15MG CAPSULE / ORAL AB RLD 1998-10-26 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N020844-002 TOPAMAX 25MG CAPSULE / ORAL AB RLD, RS 1998-10-26 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N020844-003 TOPAMAX SPRINKLE 50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** CAPSULE / ORAL RLD 1998-10-26 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N020844-001 TOPAMAX 15MG CAPSULE / ORAL AB RLD 1998-10-26 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N020844-002 TOPAMAX 25MG CAPSULE / ORAL AB RLD, RS 1998-10-26 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N020844-003 TOPAMAX SPRINKLE 50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** CAPSULE / ORAL RLD 1998-10-26 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N020844-001 TOPAMAX 15MG CAPSULE / ORAL AB RLD 1998-10-26 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N020844-002 TOPAMAX 25MG CAPSULE / ORAL AB RLD, RS 1998-10-26 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N020844-003 TOPAMAX SPRINKLE 50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** CAPSULE / ORAL RLD 1998-10-26 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N020844-001 TOPAMAX 15MG CAPSULE / ORAL AB RLD 1998-10-26 8072bd15b7f6…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 82 observed states.
Observed Orange Book patent history# 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.
NDC Listings For This Application# NDC listings for this application page 1 of 1 · 14 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 50458-645 Topamax topiramate Janssen Pharmaceuticals, Inc. NDA Current 50458-645 Topamax topiramate Janssen Pharmaceuticals, Inc. NDA Current 50458-645 Topamax topiramate Janssen Pharmaceuticals, Inc. NDA Current 50458-645 Topamax topiramate Janssen Pharmaceuticals, Inc. NDA Current 50458-645 Topamax topiramate Janssen Pharmaceuticals, Inc. NDA Current 50458-645 Topamax topiramate Janssen Pharmaceuticals, Inc. NDA Current 50458-645 Topamax topiramate Janssen Pharmaceuticals, Inc. NDA Current 50458-647 Topamax topiramate Janssen Pharmaceuticals, Inc. NDA Current 50458-647 Topamax topiramate Janssen Pharmaceuticals, Inc. NDA Current 50458-647 Topamax topiramate Janssen Pharmaceuticals, Inc. NDA Current 50458-647 Topamax topiramate Janssen Pharmaceuticals, Inc. NDA Current 50458-647 Topamax topiramate Janssen Pharmaceuticals, Inc. NDA Current 50458-647 Topamax topiramate Janssen Pharmaceuticals, Inc. NDA Current 50458-647 Topamax topiramate Janssen Pharmaceuticals, Inc. NDA Current