Last Updated: November 8, 2026

Details for New Drug Application (NDA): 217565

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NDA 217565 describes EDARAVONE, which is a drug marketed by Dr Reddys, Gland, Hikma, Long Grove Pharms, Pharmobedient, Sandoz, and Zydus Pharms, and is included in seven NDAs. It is available from three suppliers. Additional details are available on the EDARAVONE profile page.

The generic ingredient in EDARAVONE is edaravone. There is one drug master file entry for this compound. Four suppliers are listed for this compound. Additional details are available on the edaravone profile page.

Summary for 217565

Tradename:	EDARAVONE
Applicant:	Pharmobedient
Ingredient:	edaravone
Patents:	0

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	SOLUTION;INTRAVENOUS			Strength	30MG/100ML (0.3MG/ML)
Approval Date:	Oct 31, 2024	TE:		RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	DISCN	Dosage:	SOLUTION;INTRAVENOUS			Strength	60MG/100ML (0.6MG/ML)
Approval Date:	Oct 31, 2024	TE:		RLD:	No

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