Home Applications 219564 Application 219564
Type ANDA
Sponsor AJANTA PHARMA LTD Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 TOPIRAMATE TOPIRAMATE CAPSULE, EXTENDED RELEASE;ORAL 25MG No No 002 TOPIRAMATE TOPIRAMATE CAPSULE, EXTENDED RELEASE;ORAL 50MG No No 003 TOPIRAMATE TOPIRAMATE CAPSULE, EXTENDED RELEASE;ORAL 100MG No No 004 TOPIRAMATE TOPIRAMATE CAPSULE, EXTENDED RELEASE;ORAL 150MG No No 005 TOPIRAMATE TOPIRAMATE CAPSULE, EXTENDED RELEASE;ORAL 200MG No No
Source provenance: Browse the complete Orange Book source catalog · source snapshot 42 .
Orange Book products# Current product rows page 1 of 1 · 5 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A219564-001 TOPIRAMATE TOPIRAMATE 25MG CAPSULE, EXTENDED RELEASE / ORAL AB2 2025-09-02 A219564-002 TOPIRAMATE TOPIRAMATE 50MG CAPSULE, EXTENDED RELEASE / ORAL AB2 2025-09-02 A219564-003 TOPIRAMATE TOPIRAMATE 100MG CAPSULE, EXTENDED RELEASE / ORAL AB2 2025-09-02 A219564-004 TOPIRAMATE TOPIRAMATE 150MG CAPSULE, EXTENDED RELEASE / ORAL AB2 2025-09-02 A219564-005 TOPIRAMATE TOPIRAMATE 200MG CAPSULE, EXTENDED RELEASE / ORAL AB2 2025-09-02
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 5 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.
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 2026-08-18 06:07:40 2026-07 A219564-001 TOPIRAMATE 25MG CAPSULE, EXTENDED RELEASE / ORAL AB2 2025-09-02 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A219564-002 TOPIRAMATE 50MG CAPSULE, EXTENDED RELEASE / ORAL AB2 2025-09-02 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A219564-003 TOPIRAMATE 100MG CAPSULE, EXTENDED RELEASE / ORAL AB2 2025-09-02 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A219564-004 TOPIRAMATE 150MG CAPSULE, EXTENDED RELEASE / ORAL AB2 2025-09-02 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A219564-005 TOPIRAMATE 200MG CAPSULE, EXTENDED RELEASE / ORAL AB2 2025-09-02 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A219564-001 TOPIRAMATE 25MG CAPSULE, EXTENDED RELEASE / ORAL AB2 2025-09-02 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A219564-002 TOPIRAMATE 50MG CAPSULE, EXTENDED RELEASE / ORAL AB2 2025-09-02 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A219564-003 TOPIRAMATE 100MG CAPSULE, EXTENDED RELEASE / ORAL AB2 2025-09-02 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A219564-004 TOPIRAMATE 150MG CAPSULE, EXTENDED RELEASE / ORAL AB2 2025-09-02 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A219564-005 TOPIRAMATE 200MG CAPSULE, EXTENDED RELEASE / ORAL AB2 2025-09-02 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A219564-001 TOPIRAMATE 25MG CAPSULE, EXTENDED RELEASE / ORAL AB2 2025-09-02 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A219564-002 TOPIRAMATE 50MG CAPSULE, EXTENDED RELEASE / ORAL AB2 2025-09-02 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A219564-003 TOPIRAMATE 100MG CAPSULE, EXTENDED RELEASE / ORAL AB2 2025-09-02 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A219564-004 TOPIRAMATE 150MG CAPSULE, EXTENDED RELEASE / ORAL AB2 2025-09-02 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A219564-005 TOPIRAMATE 200MG CAPSULE, EXTENDED RELEASE / ORAL AB2 2025-09-02 31067a03dcf5…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A219564-001 TOPIRAMATE 25MG CAPSULE, EXTENDED RELEASE / ORAL AB2 2025-09-02 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A219564-002 TOPIRAMATE 50MG CAPSULE, EXTENDED RELEASE / ORAL AB2 2025-09-02 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A219564-003 TOPIRAMATE 100MG CAPSULE, EXTENDED RELEASE / ORAL AB2 2025-09-02 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A219564-004 TOPIRAMATE 150MG CAPSULE, EXTENDED RELEASE / ORAL AB2 2025-09-02 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A219564-005 TOPIRAMATE 200MG CAPSULE, EXTENDED RELEASE / ORAL AB2 2025-09-02 a50c72e98297…
Observed Orange Book normalized TE 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.