Home Applications 209538 Application 209538
Type ANDA
Sponsor TARO PHARM INDS LTD Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 PERAMPANEL PERAMPANEL TABLET;ORAL 2MG No No 002 PERAMPANEL PERAMPANEL TABLET;ORAL 4MG No No 003 PERAMPANEL PERAMPANEL TABLET;ORAL 6MG No No 004 PERAMPANEL PERAMPANEL TABLET;ORAL 8MG No No 005 PERAMPANEL PERAMPANEL TABLET;ORAL 10MG No No 006 PERAMPANEL PERAMPANEL TABLET;ORAL 12MG No No
Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
Orange Book products# Current product rows page 1 of 1 · 6 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A209538-001 PERAMPANEL PERAMPANEL 2MG TABLET / ORAL AB 2025-11-25 A209538-002 PERAMPANEL PERAMPANEL 4MG TABLET / ORAL AB 2025-11-25 A209538-003 PERAMPANEL PERAMPANEL 6MG TABLET / ORAL AB 2025-11-25 A209538-004 PERAMPANEL PERAMPANEL 8MG TABLET / ORAL AB 2025-11-25 A209538-005 PERAMPANEL PERAMPANEL 10MG TABLET / ORAL AB 2025-11-25 A209538-006 PERAMPANEL PERAMPANEL 12MG TABLET / ORAL AB 2025-11-25
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 6 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 A209538-001 PERAMPANEL 2MG TABLET / ORAL AB 2025-11-25 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A209538-002 PERAMPANEL 4MG TABLET / ORAL AB 2025-11-25 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A209538-003 PERAMPANEL 6MG TABLET / ORAL AB 2025-11-25 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A209538-004 PERAMPANEL 8MG TABLET / ORAL AB 2025-11-25 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A209538-005 PERAMPANEL 10MG TABLET / ORAL AB 2025-11-25 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A209538-006 PERAMPANEL 12MG TABLET / ORAL AB 2025-11-25 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A209538-001 PERAMPANEL 2MG TABLET / ORAL AB 2025-11-25 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A209538-002 PERAMPANEL 4MG TABLET / ORAL AB 2025-11-25 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A209538-003 PERAMPANEL 6MG TABLET / ORAL AB 2025-11-25 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A209538-004 PERAMPANEL 8MG TABLET / ORAL AB 2025-11-25 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A209538-005 PERAMPANEL 10MG TABLET / ORAL AB 2025-11-25 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A209538-006 PERAMPANEL 12MG TABLET / ORAL AB 2025-11-25 31067a03dcf5…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A209538-001 PERAMPANEL 2MG TABLET / ORAL AB 2025-11-25 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A209538-002 PERAMPANEL 4MG TABLET / ORAL AB 2025-11-25 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A209538-003 PERAMPANEL 6MG TABLET / ORAL AB 2025-11-25 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A209538-004 PERAMPANEL 8MG TABLET / ORAL AB 2025-11-25 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A209538-005 PERAMPANEL 10MG TABLET / ORAL AB 2025-11-25 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A209538-006 PERAMPANEL 12MG TABLET / ORAL AB 2025-11-25 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.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Perampanel PERAMPANEL Sun Pharmaceutical Industries, Inc. 1b0458ea-e718-4d48-ae55-ad9b4d863810 2025-12-19 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 209538 application number: ANDA209538