Home Applications 078418 Application 078418
Type ANDA
Sponsor MYLAN Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 TOPIRAMATE TOPIRAMATE CAPSULE;ORAL 15MG No No 002 TOPIRAMATE TOPIRAMATE CAPSULE;ORAL 25MG No No 003 TOPIRAMATE 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 A078418-001 TOPIRAMATE TOPIRAMATE 15MG CAPSULE / ORAL AB 2009-10-14 A078418-002 TOPIRAMATE TOPIRAMATE 25MG CAPSULE / ORAL AB 2009-10-14 A078418-003 TOPIRAMATE TOPIRAMATE 50MG CAPSULE / ORAL AB 2026-02-02
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 3 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 3 · 84 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 A078418-001 TOPIRAMATE 15MG CAPSULE / ORAL AB 2009-10-14 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A078418-002 TOPIRAMATE 25MG CAPSULE / ORAL AB 2009-10-14 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A078418-003 TOPIRAMATE 50MG CAPSULE / ORAL AB 2026-02-02 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A078418-001 TOPIRAMATE 15MG CAPSULE / ORAL AB 2009-10-14 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A078418-002 TOPIRAMATE 25MG CAPSULE / ORAL AB 2009-10-14 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A078418-001 TOPIRAMATE 15MG CAPSULE / ORAL AB 2009-10-14 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A078418-002 TOPIRAMATE 25MG CAPSULE / ORAL AB 2009-10-14 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A078418-001 TOPIRAMATE 15MG CAPSULE / ORAL AB 2009-10-14 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A078418-002 TOPIRAMATE 25MG CAPSULE / ORAL AB 2009-10-14 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A078418-001 TOPIRAMATE 15MG CAPSULE / ORAL AB 2009-10-14 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A078418-002 TOPIRAMATE 25MG CAPSULE / ORAL AB 2009-10-14 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A078418-001 TOPIRAMATE 15MG CAPSULE / ORAL AB 2009-10-14 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A078418-002 TOPIRAMATE 25MG CAPSULE / ORAL AB 2009-10-14 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A078418-001 TOPIRAMATE 15MG CAPSULE / ORAL AB 2009-10-14 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A078418-002 TOPIRAMATE 25MG CAPSULE / ORAL AB 2009-10-14 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A078418-001 TOPIRAMATE 15MG CAPSULE / ORAL AB 2009-10-14 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A078418-002 TOPIRAMATE 25MG CAPSULE / ORAL AB 2009-10-14 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A078418-001 TOPIRAMATE 15MG CAPSULE / ORAL AB 2009-10-14 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A078418-002 TOPIRAMATE 25MG CAPSULE / ORAL AB 2009-10-14 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A078418-001 TOPIRAMATE 15MG CAPSULE / ORAL AB 2009-10-14 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A078418-002 TOPIRAMATE 25MG CAPSULE / ORAL AB 2009-10-14 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A078418-001 TOPIRAMATE 15MG CAPSULE / ORAL AB 2009-10-14 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A078418-002 TOPIRAMATE 25MG CAPSULE / ORAL AB 2009-10-14 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A078418-001 TOPIRAMATE 15MG CAPSULE / ORAL AB 2009-10-14 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A078418-002 TOPIRAMATE 25MG CAPSULE / ORAL AB 2009-10-14 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A078418-001 TOPIRAMATE 15MG CAPSULE / ORAL AB 2009-10-14 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A078418-002 TOPIRAMATE 25MG CAPSULE / ORAL AB 2009-10-14 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A078418-001 TOPIRAMATE 15MG CAPSULE / ORAL AB 2009-10-14 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A078418-002 TOPIRAMATE 25MG CAPSULE / ORAL AB 2009-10-14 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A078418-001 TOPIRAMATE 15MG CAPSULE / ORAL 2009-10-14 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A078418-002 TOPIRAMATE 25MG CAPSULE / ORAL 2009-10-14 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A078418-001 TOPIRAMATE 15MG CAPSULE / ORAL 2009-10-14 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A078418-002 TOPIRAMATE 25MG CAPSULE / ORAL 2009-10-14 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A078418-001 TOPIRAMATE 15MG CAPSULE / ORAL 2009-10-14 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A078418-002 TOPIRAMATE 25MG CAPSULE / ORAL 2009-10-14 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A078418-001 TOPIRAMATE 15MG CAPSULE / ORAL 2009-10-14 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A078418-002 TOPIRAMATE 25MG CAPSULE / ORAL 2009-10-14 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A078418-001 TOPIRAMATE 15MG CAPSULE / ORAL 2009-10-14 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A078418-002 TOPIRAMATE 25MG CAPSULE / ORAL 2009-10-14 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A078418-001 TOPIRAMATE 15MG CAPSULE / ORAL 2009-10-14 782e0a99824c…
Observed Orange Book normalized TE history# openFDA label cross-check# Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.
Matched openFDA labels page 1 of 1 · 1 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join TOPIRAMATE TOPIRAMATE SPINKLE Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. 1730870d-e661-41f9-bd0d-d8daaf087819 2025-12-25 Warnings, Adverse reactions Exact identifier application applno (ANDA): 078418 application number: ANDA078418