Application 215917

Type: ANDA
Sponsor: DR REDDYS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	EDARAVONE	EDARAVONE	SOLUTION;INTRAVENOUS	60MG/100ML (0.6MG/ML)	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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
A215917-001	EDARAVONE	EDARAVONE	60MG/100ML (0.6MG/ML)	SOLUTION / INTRAVENOUS			2024-05-06

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	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A215917-001	EDARAVONE	60MG/100ML (0.6MG/ML)	SOLUTION / INTRAVENOUS	AP	2024-05-06	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A215917-001	EDARAVONE	60MG/100ML (0.6MG/ML)	SOLUTION / INTRAVENOUS	AP	2024-05-06	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A215917-001	EDARAVONE	60MG/100ML (0.6MG/ML)	SOLUTION / INTRAVENOUS	AP	2024-05-06	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A215917-001	EDARAVONE	60MG/100ML (0.6MG/ML)	SOLUTION / INTRAVENOUS	AP	2024-05-06	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A215917-001	EDARAVONE	60MG/100ML (0.6MG/ML)	SOLUTION / INTRAVENOUS	AP	2024-05-06	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A215917-001	EDARAVONE	60MG/100ML (0.6MG/ML)	SOLUTION / INTRAVENOUS	AP	2024-05-06	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A215917-001	EDARAVONE	60MG/100ML (0.6MG/ML)	SOLUTION / INTRAVENOUS	AP	2024-05-06	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A215917-001	EDARAVONE	60MG/100ML (0.6MG/ML)	SOLUTION / INTRAVENOUS	AP	2024-05-06	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A215917-001	EDARAVONE	60MG/100ML (0.6MG/ML)	SOLUTION / INTRAVENOUS	AP	2024-05-06	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A215917-001	EDARAVONE	60MG/100ML (0.6MG/ML)	SOLUTION / INTRAVENOUS	AP	2024-05-06	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A215917-001	EDARAVONE	60MG/100ML (0.6MG/ML)	SOLUTION / INTRAVENOUS	AP	2024-05-06	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A215917-001	EDARAVONE	60MG/100ML (0.6MG/ML)	SOLUTION / INTRAVENOUS	AP	2024-05-06	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A215917-001	EDARAVONE	60MG/100ML (0.6MG/ML)	SOLUTION / INTRAVENOUS	AP	2024-05-06	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A215917-001	EDARAVONE	60MG/100ML (0.6MG/ML)	SOLUTION / INTRAVENOUS	AP	2024-05-06	`8072bd15b7f6…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A215917-001	EDARAVONE	60MG/100ML (0.6MG/ML)	SOLUTION / INTRAVENOUS		2024-05-06	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A215917-001	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A215917-001	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A215917-001	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A215917-001	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A215917-001	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A215917-001	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A215917-001	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A215917-001	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A215917-001	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A215917-001	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A215917-001	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A215917-001	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A215917-001	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A215917-001	AP	1	`8072bd15b7f6…`

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 · 5 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	Name fallback brand name: edaravone generic name: EDARAVONE
RADICAVA ORS	EDARAVONE	Shionogi Inc.	0ce2c1c4-2a40-485c-b7cb-96a9b85d9d11	2026-05-05	Warnings, Adverse reactions	Name fallback generic name: EDARAVONE
Edaravone	EDARAVONE	Piramal Critical Care Inc.	19862ae9-d6e1-70e6-e063-6394a90ae749	2025-10-07	Warnings, Adverse reactions	Name fallback brand name: Edaravone generic name: EDARAVONE
edaravone	EDARAVONE	Gland Pharma Limited	46452eb5-db17-400d-b25b-11844a11e711	2024-05-07	Warnings, Adverse reactions	Name fallback brand name: edaravone generic name: EDARAVONE
Edaravone	EDARAVONE	Sandoz Inc	ae940bc6-1e6a-4b76-825c-bd2e1925e39a	2023-10-01	Warnings, Adverse reactions	Name fallback brand name: Edaravone generic name: EDARAVONE