Home Applications 217565 Application 217565
Type ANDA
Sponsor PHARMOBEDIENT Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 EDARAVONE EDARAVONE SOLUTION;INTRAVENOUS 30MG/100ML (0.3MG/ML) No No 002 EDARAVONE EDARAVONE SOLUTION;INTRAVENOUS 60MG/100ML (0.6MG/ML) No Yes
Source provenance: Browse the complete Orange Book source catalog · source snapshot 42 .
Orange Book products# Current product rows page 1 of 1 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A217565-001 EDARAVONE EDARAVONE 30MG/100ML (0.3MG/ML) SOLUTION / INTRAVENOUS 2024-10-31 A217565-002 EDARAVONE EDARAVONE 60MG/100ML (0.6MG/ML) SOLUTION / INTRAVENOUS 2024-10-31
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 A217565-001 EDARAVONE 30MG/100ML (0.3MG/ML) SOLUTION / INTRAVENOUS 2024-10-31 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A217565-002 EDARAVONE 60MG/100ML (0.6MG/ML) SOLUTION / INTRAVENOUS 2024-10-31 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A217565-001 EDARAVONE 30MG/100ML (0.3MG/ML) SOLUTION / INTRAVENOUS AP 2024-10-31 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A217565-002 EDARAVONE 60MG/100ML (0.6MG/ML) SOLUTION / INTRAVENOUS AP RS 2024-10-31 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A217565-001 EDARAVONE 30MG/100ML (0.3MG/ML) SOLUTION / INTRAVENOUS AP 2024-10-31 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A217565-002 EDARAVONE 60MG/100ML (0.6MG/ML) SOLUTION / INTRAVENOUS AP RS 2024-10-31 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A217565-001 EDARAVONE 30MG/100ML (0.3MG/ML) SOLUTION / INTRAVENOUS AP 2024-10-31 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A217565-002 EDARAVONE 60MG/100ML (0.6MG/ML) SOLUTION / INTRAVENOUS AP 2024-10-31 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A217565-001 EDARAVONE 30MG/100ML (0.3MG/ML) SOLUTION / INTRAVENOUS AP 2024-10-31 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A217565-002 EDARAVONE 60MG/100ML (0.6MG/ML) SOLUTION / INTRAVENOUS AP 2024-10-31 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A217565-001 EDARAVONE 30MG/100ML (0.3MG/ML) SOLUTION / INTRAVENOUS AP 2024-10-31 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A217565-002 EDARAVONE 60MG/100ML (0.6MG/ML) SOLUTION / INTRAVENOUS AP 2024-10-31 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A217565-001 EDARAVONE 30MG/100ML (0.3MG/ML) SOLUTION / INTRAVENOUS AP 2024-10-31 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A217565-002 EDARAVONE 60MG/100ML (0.6MG/ML) SOLUTION / INTRAVENOUS AP 2024-10-31 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A217565-001 EDARAVONE 30MG/100ML (0.3MG/ML) SOLUTION / INTRAVENOUS AP 2024-10-31 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A217565-002 EDARAVONE 60MG/100ML (0.6MG/ML) SOLUTION / INTRAVENOUS AP 2024-10-31 2680178bc6a6…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A217565-001 EDARAVONE 30MG/100ML (0.3MG/ML) SOLUTION / INTRAVENOUS AP 2024-10-31 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A217565-002 EDARAVONE 60MG/100ML (0.6MG/ML) SOLUTION / INTRAVENOUS AP 2024-10-31 d8e5a09893c0…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A217565-001 EDARAVONE 30MG/100ML (0.3MG/ML) SOLUTION / INTRAVENOUS 2024-10-31 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A217565-002 EDARAVONE 60MG/100ML (0.6MG/ML) SOLUTION / INTRAVENOUS 2024-10-31 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 edaravone EDARAVONE XGen Pharmaceuticals DJB, Inc. a8245a98-2ccb-4062-b865-3aa348351b48 2026-05-28 Warnings, Adverse reactions Exact identifier application applno (ANDA): 217565 application number: ANDA217565