Home Applications 209176 Application 209176
Type NDA
Sponsor MITSUBISHI TANABE Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 RADICAVA EDARAVONE SOLUTION;INTRAVENOUS 30MG/100ML (0.3MG/ML) Yes Yes 002 RADICAVA EDARAVONE SOLUTION;INTRAVENOUS 60MG/100ML (0.6MG/ML) Yes 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 N209176-001 RADICAVA EDARAVONE 30MG/100ML (0.3MG/ML) SOLUTION / INTRAVENOUS RLD 2017-05-05 N209176-002 RADICAVA EDARAVONE 60MG/100ML (0.6MG/ML) SOLUTION / INTRAVENOUS RLD 2018-11-15
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 2026-08-18 06:07:40 2026-07 N209176-001 RADICAVA 30MG/100ML (0.3MG/ML) SOLUTION / INTRAVENOUS RLD 2017-05-05 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N209176-002 RADICAVA 60MG/100ML (0.6MG/ML) SOLUTION / INTRAVENOUS RLD 2018-11-15 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N209176-001 RADICAVA 30MG/100ML (0.3MG/ML) SOLUTION / INTRAVENOUS RLD 2017-05-05 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N209176-002 RADICAVA 60MG/100ML (0.6MG/ML) SOLUTION / INTRAVENOUS AP RLD 2018-11-15 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N209176-001 RADICAVA 30MG/100ML (0.3MG/ML) SOLUTION / INTRAVENOUS RLD 2017-05-05 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N209176-002 RADICAVA 60MG/100ML (0.6MG/ML) SOLUTION / INTRAVENOUS AP RLD 2018-11-15 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N209176-001 RADICAVA 30MG/100ML (0.3MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2017-05-05 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N209176-002 RADICAVA 60MG/100ML (0.6MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2018-11-15 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N209176-001 RADICAVA 30MG/100ML (0.3MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2017-05-05 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N209176-002 RADICAVA 60MG/100ML (0.6MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2018-11-15 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N209176-001 RADICAVA 30MG/100ML (0.3MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2017-05-05 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N209176-002 RADICAVA 60MG/100ML (0.6MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2018-11-15 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N209176-001 RADICAVA 30MG/100ML (0.3MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2017-05-05 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N209176-002 RADICAVA 60MG/100ML (0.6MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2018-11-15 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N209176-001 RADICAVA 30MG/100ML (0.3MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2017-05-05 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N209176-002 RADICAVA 60MG/100ML (0.6MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2018-11-15 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N209176-001 RADICAVA 30MG/100ML (0.3MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2017-05-05 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N209176-002 RADICAVA 60MG/100ML (0.6MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2018-11-15 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N209176-001 RADICAVA 30MG/100ML (0.3MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2017-05-05 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N209176-002 RADICAVA 60MG/100ML (0.6MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2018-11-15 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N209176-001 RADICAVA 30MG/100ML (0.3MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2017-05-05 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N209176-002 RADICAVA 60MG/100ML (0.6MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2018-11-15 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N209176-001 RADICAVA 30MG/100ML (0.3MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2017-05-05 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N209176-002 RADICAVA 60MG/100ML (0.6MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2018-11-15 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N209176-001 RADICAVA 30MG/100ML (0.3MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2017-05-05 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N209176-002 RADICAVA 60MG/100ML (0.6MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2018-11-15 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N209176-001 RADICAVA 30MG/100ML (0.3MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2017-05-05 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N209176-002 RADICAVA 60MG/100ML (0.6MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2018-11-15 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N209176-001 RADICAVA 30MG/100ML (0.3MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2017-05-05 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 N209176-002 RADICAVA 60MG/100ML (0.6MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2018-11-15 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N209176-001 RADICAVA 30MG/100ML (0.3MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2017-05-05 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N209176-002 RADICAVA 60MG/100ML (0.6MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2018-11-15 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N209176-001 RADICAVA 30MG/100ML (0.3MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2017-05-05 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N209176-002 RADICAVA 60MG/100ML (0.6MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2018-11-15 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N209176-001 RADICAVA 30MG/100ML (0.3MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2017-05-05 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N209176-002 RADICAVA 60MG/100ML (0.6MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2018-11-15 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N209176-001 RADICAVA 30MG/100ML (0.3MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2017-05-05 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N209176-002 RADICAVA 60MG/100ML (0.6MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2018-11-15 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N209176-001 RADICAVA 30MG/100ML (0.3MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2017-05-05 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 N209176-002 RADICAVA 60MG/100ML (0.6MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2018-11-15 bb7c543d1eb4…
Observed Orange Book normalized TE history# Observed Orange Book patent history# Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2019-12-13 00:20 UTC 2019-12 N209176-001 6933310 2020-11-13 U-2013 2017-05-31 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N209176-002 6933310 2020-11-13 U-2013 2018-12-04 74a2ff9319b5…2020-12-22 03:56 UTC 2020-12 N209176-001 6933310 2020-11-13 U-2013 2017-05-31 8869cabd3fbd…2020-12-22 03:56 UTC 2020-12 N209176-002 6933310 2020-11-13 U-2013 2018-12-04 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N209176-001 6933310 2020-11-13 U-2013 2017-05-31 c0c555d07b60…2020-11-12 02:37 UTC 2020-11 N209176-002 6933310 2020-11-13 U-2013 2018-12-04 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N209176-001 6933310 2020-11-13 U-2013 2017-05-31 3f01610625f2…2019-12-14 00:12 UTC 2019-12 N209176-002 6933310 2020-11-13 U-2013 2018-12-04 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N209176-001 6933310 2020-11-13 U-2013 2017-05-31 b00525d2431f…2019-09-15 20:21 UTC 2019-09 N209176-002 6933310 2020-11-13 U-2013 2018-12-04 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N209176-001 6933310 2020-11-13 U-2013 2017-05-31 ea99ee380514…2019-07-19 19:46 UTC 2019-07 N209176-002 6933310 2020-11-13 U-2013 2018-12-04 ea99ee380514…
Observed Orange Book exclusivity history# Exclusivity history page 1 of 3 · 95 observed states.
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.
NDC Listings For This Application# NDC listings for this application page 1 of 1 · 12 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 70510-2171 RADICAVA EDARAVONE Mitsubishi Tanabe Pharma America, Inc. NDA Current 70510-2171 RADICAVA edaravone Mitsubishi Tanabe Pharma America, Inc. NDA Current 70510-2171 RADICAVA EDARAVONE Mitsubishi Tanabe Pharma America, Inc. NDA Current 70510-2171 RADICAVA EDARAVONE Mitsubishi Tanabe Pharma America, Inc. NDA Current 70510-2171 RADICAVA EDARAVONE Mitsubishi Tanabe Pharma America, Inc. NDA Current 70510-2171 RADICAVA edaravone Mitsubishi Tanabe Pharma America, Inc. NDA Current 70510-2171 RADICAVA edaravone Mitsubishi Tanabe Pharma America, Inc. NDA Current 70510-2171 RADICAVA edaravone Mitsubishi Tanabe Pharma America, Inc. NDA Current 70510-2171 RADICAVA edaravone Mitsubishi Tanabe Pharma America, Inc. NDA Current 70510-2171 RADICAVA edaravone Mitsubishi Tanabe Pharma America, Inc. NDA Current 70510-2171 RADICAVA edaravone Mitsubishi Tanabe Pharma America, Inc. NDA Current 70510-2172 RADICAVA edaravone Mitsubishi Tanabe Pharma America, Inc. NDA Current
Documents# Document, Submission type, Date table Document Submission type Date 72669 SUPPL 2022-11-22 72656 SUPPL 2022-11-20 66797 SUPPL 2021-03-17 66791 SUPPL 2021-03-16 60782 SUPPL 2019-11-05 60779 SUPPL 2019-11-05 59619 SUPPL 2019-08-07 59012 SUPPL 2019-06-11 58338 SUPPL 2019-04-15 48785 ORIG 2017-06-20 48297 ORIG 2017-05-09 48276 ORIG 2017-05-08