Application 215446

Type: NDA
Sponsor: MITSUBISHI TANABE

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	RADICAVA ORS	EDARAVONE	SOLUTION;INTRAVENOUS	105MG/5ML	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N215446-001	RADICAVA ORS	EDARAVONE	105MG/5ML	SUSPENSION / ORAL		RLD, RS	2022-05-12

Orange Book patents#

Current patent rows page 1 of 1 · 12 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N215446-001	10987341	2039-11-01		Drug product	2022-06-07
N215446-001	11241416	2039-11-01		Drug product	2022-06-07
N215446-001	11478450	2039-11-01	U-3468		2022-11-15
N215446-001	11826352	2039-11-01		Drug product	2023-12-05
N215446-001	11957660	2039-11-01		Drug product	2024-05-09
N215446-001	12285409	2039-11-01		Drug product	2025-05-06
N215446-001	12599586	2039-11-01		Drug product	2026-04-28
N215446-001	12194025	2041-11-12	U-4111		2025-02-11
N215446-001	12310946	2041-11-12	U-4111		2025-06-20
N215446-001	12478611	2041-11-12	U-4111		2025-12-18
N215446-001	12527769	2041-11-12	U-4111		2026-02-10
N215446-001	12569469	2041-11-12	U-4111		2026-03-24

Orange Book exclusivity#

Current exclusivity rows page 1 of 1 · 1 matching rows.

Application-product, Exclusivity code, Expiration table
Application-product	Exclusivity code	Expiration
N215446-001	ODE-144	2029-05-12

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	RLD / RS	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	N215446-001	RADICAVA ORS	105MG/5ML	SUSPENSION / ORAL	RLD, RS	2022-05-12	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N215446-001	RADICAVA ORS	105MG/5ML	SUSPENSION / ORAL	RLD, RS	2022-05-12	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N215446-001	RADICAVA ORS	105MG/5ML	SUSPENSION / ORAL	RLD, RS	2022-05-12	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N215446-001	RADICAVA ORS	105MG/5ML	SUSPENSION / ORAL	RLD, RS	2022-05-12	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N215446-001	RADICAVA ORS	105MG/5ML	SUSPENSION / ORAL	RLD, RS	2022-05-12	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N215446-001	RADICAVA ORS	105MG/5ML	SUSPENSION / ORAL	RLD, RS	2022-05-12	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N215446-001	RADICAVA ORS	105MG/5ML	SUSPENSION / ORAL	RLD, RS	2022-05-12	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N215446-001	RADICAVA ORS	105MG/5ML	SUSPENSION / ORAL	RLD, RS	2022-05-12	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N215446-001	RADICAVA ORS	105MG/5ML	SUSPENSION / ORAL	RLD, RS	2022-05-12	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N215446-001	RADICAVA ORS	105MG/5ML	SUSPENSION / ORAL	RLD, RS	2022-05-12	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N215446-001	RADICAVA ORS	105MG/5ML	SUSPENSION / ORAL	RLD, RS	2022-05-12	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N215446-001	RADICAVA ORS	105MG/5ML	SUSPENSION / ORAL	RLD, RS	2022-05-12	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N215446-001	RADICAVA ORS	105MG/5ML	SUSPENSION / ORAL	RLD, RS	2022-05-12	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N215446-001	RADICAVA ORS	105MG/5ML	SUSPENSION / ORAL	RLD, RS	2022-05-12	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N215446-001	RADICAVA ORS	105MG/5ML	SUSPENSION / ORAL	RLD, RS	2022-05-12	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N215446-001	RADICAVA ORS	105MG/5ML	SUSPENSION / ORAL	RLD, RS	2022-05-12	`5c6f7cd8ea54…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N215446-001	RADICAVA ORS	105MG/5ML	SUSPENSION / ORAL	RLD, RS	2022-05-12	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N215446-001	RADICAVA ORS	105MG/5ML	SUSPENSION / ORAL	RLD, RS	2022-05-12	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N215446-001	RADICAVA ORS	105MG/5ML	SUSPENSION / ORAL	RLD, RS	2022-05-12	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N215446-001	RADICAVA ORS	105MG/5ML	SUSPENSION / ORAL	RLD, RS	2022-05-12	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N215446-001	RADICAVA ORS	105MG/5ML	SUSPENSION / ORAL	RLD, RS	2022-05-12	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N215446-001	RADICAVA ORS	105MG/5ML	SUSPENSION / ORAL	RLD, RS	2022-05-12	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N215446-001	RADICAVA ORS	105MG/5ML	SUSPENSION / ORAL	RLD, RS	2022-05-12	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N215446-001	RADICAVA ORS	105MG/5ML	SUSPENSION / ORAL	RLD, RS	2022-05-12	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N215446-001	RADICAVA ORS	105MG/5ML	SUSPENSION / ORAL	RLD, RS	2022-05-12	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N215446-001	RADICAVA ORS	105MG/5ML	SUSPENSION / ORAL	RLD, RS	2022-05-12	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N215446-001	RADICAVA ORS	105MG/5ML	SUSPENSION / ORAL	RLD, RS	2022-05-12	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N215446-001	RADICAVA ORS	105MG/5ML	SUSPENSION / ORAL	RLD, RS	2022-05-12	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N215446-001	RADICAVA ORS	105MG/5ML	SUSPENSION / ORAL	RLD, RS	2022-05-12	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N215446-001	RADICAVA ORS	105MG/5ML	SUSPENSION / ORAL	RLD, RS	2022-05-12	`a50c72e98297…`

Observed Orange Book patent history#

Patent history page 1 of 4 · 147 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2026-08-18 06:07:40	2026-07	N215446-001	10987341	2039-11-01		Drug product	2022-06-07	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N215446-001	11241416	2039-11-01		Drug product	2022-06-07	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N215446-001	11478450	2039-11-01	U-3468		2022-11-15	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N215446-001	11826352	2039-11-01		Drug product	2023-12-05	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N215446-001	11957660	2039-11-01		Drug product	2024-05-09	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N215446-001	12285409	2039-11-01		Drug product	2025-05-06	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N215446-001	12599586	2039-11-01		Drug product	2026-04-28	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N215446-001	12194025	2041-11-12	U-4111		2025-02-11	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N215446-001	12310946	2041-11-12	U-4111		2025-06-20	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N215446-001	12478611	2041-11-12	U-4111		2025-12-18	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N215446-001	12527769	2041-11-12	U-4111		2026-02-10	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N215446-001	12569469	2041-11-12	U-4111		2026-03-24	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N215446-001	10987341	2039-11-01		Drug product	2022-06-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215446-001	11241416	2039-11-01		Drug product	2022-06-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215446-001	11478450	2039-11-01	U-3468		2022-11-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215446-001	11826352	2039-11-01		Drug product	2023-12-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215446-001	11957660	2039-11-01		Drug product	2024-05-09	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215446-001	12285409	2039-11-01		Drug product	2025-05-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215446-001	12194025	2041-11-12	U-4111		2025-02-11	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215446-001	12310946	2041-11-12	U-4111		2025-06-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215446-001	12478611	2041-11-12	U-4111		2025-12-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215446-001	12527769	2041-11-12	U-4111		2026-02-10	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N215446-001	10987341	2039-11-01		Drug product	2022-06-07	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N215446-001	11241416	2039-11-01		Drug product	2022-06-07	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N215446-001	11478450	2039-11-01	U-3468		2022-11-15	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N215446-001	11826352	2039-11-01		Drug product	2023-12-05	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N215446-001	11957660	2039-11-01		Drug product	2024-05-09	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N215446-001	12285409	2039-11-01		Drug product	2025-05-06	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N215446-001	12194025	2041-11-12	U-4111		2025-02-11	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N215446-001	12310946	2041-11-12	U-4111		2025-06-20	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N215446-001	10987341	2039-11-01		Drug product	2022-06-07	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N215446-001	11241416	2039-11-01		Drug product	2022-06-07	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N215446-001	11478450	2039-11-01	U-3468		2022-11-15	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N215446-001	11826352	2039-11-01		Drug product	2023-12-05	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N215446-001	11957660	2039-11-01		Drug product	2024-05-09	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N215446-001	12285409	2039-11-01		Drug product	2025-05-06	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N215446-001	12194025	2041-11-12	U-4111		2025-02-11	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N215446-001	12310946	2041-11-12	U-4111		2025-06-20	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N215446-001	10987341	2039-11-01		Drug product	2022-06-07	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N215446-001	11241416	2039-11-01		Drug product	2022-06-07	`fd3edfee7708…`

Observed Orange Book exclusivity history#

Exclusivity history page 1 of 2 · 42 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2026-08-18 06:07:40	2026-07	N215446-001	ODE-144	2029-05-12	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N215446-001	ODE-144	2029-05-12	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N215446-001	NP	2025-05-12	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N215446-001	ODE-144	2029-05-12	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N215446-001	NP	2025-05-12	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N215446-001	ODE-144	2029-05-12	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N215446-001	NP	2025-05-12	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N215446-001	ODE-144	2029-05-12	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N215446-001	NP	2025-05-12	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N215446-001	ODE-144	2029-05-12	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N215446-001	NP	2025-05-12	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N215446-001	ODE-144	2029-05-12	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N215446-001	NP	2025-05-12	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N215446-001	ODE-144	2029-05-12	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N215446-001	NP	2025-05-12	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N215446-001	ODE-144	2029-05-12	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N215446-001	NP	2025-05-12	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N215446-001	ODE-144	2029-05-12	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N215446-001	NP	2025-05-12	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N215446-001	ODE-144	2029-05-12	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N215446-001	NP	2025-05-12	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N215446-001	ODE-144	2029-05-12	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N215446-001	NP	2025-05-12	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N215446-001	ODE-144	2029-05-12	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N215446-001	NP	2025-05-12	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N215446-001	ODE-144	2029-05-12	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N215446-001	NP	2025-05-12	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N215446-001	ODE-144	2029-05-12	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N215446-001	NP	2025-05-12	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N215446-001	NP	2025-05-12	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N215446-001	NP	2025-05-12	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N215446-001	NP	2025-05-12	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N215446-001	NP	2025-05-12	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N215446-001	NP	2025-05-12	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N215446-001	NP	2025-05-12	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N215446-001	NP	2025-05-12	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N215446-001	NP	2025-05-12	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N215446-001	NP	2025-05-12	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N215446-001	NP	2025-05-12	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N215446-001	NP	2025-05-12	`e64feba35796…`

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
RADICAVA ORS	EDARAVONE	Shionogi Inc.	0ce2c1c4-2a40-485c-b7cb-96a9b85d9d11	2026-05-05	Warnings, Adverse reactions	Exact identifier application applno (NDA): 215446 application number: NDA215446 ndc (product): 70510-2321 ndc (product): 70510-2322

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 8 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
70510-2321	RADICAVA ORS	EDARAVONE	Mitsubishi Tanabe Pharma America, Inc.	NDA	Current
70510-2321	RADICAVA ORS	EDARAVONE	Mitsubishi Tanabe Pharma America, Inc.	NDA	Current
70510-2321	RADICAVA ORS	EDARAVONE	Mitsubishi Tanabe Pharma America, Inc.	NDA	Current
70510-2321	RADICAVA ORS	EDARAVONE	Mitsubishi Tanabe Pharma America, Inc.	NDA	Current
70510-2322	RADICAVA ORS	EDARAVONE	Mitsubishi Tanabe Pharma America, Inc.	NDA	Current
70510-2322	RADICAVA ORS	EDARAVONE	Mitsubishi Tanabe Pharma America, Inc.	NDA	Current
70510-2322	RADICAVA ORS	EDARAVONE	Mitsubishi Tanabe Pharma America, Inc.	NDA	Current
70510-2322	RADICAVA ORS	EDARAVONE	Mitsubishi Tanabe Pharma America, Inc.	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
73712	ORIG	2023-03-09
71075	ORIG	2022-05-16
71067	ORIG	2022-05-13