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 1 .
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 2026-02-19 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# 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.