Last Updated: November 8, 2026

Details for New Drug Application (NDA): 218349

NDA 218349 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 218349

Tradename:	EDARAVONE
Applicant:	Zydus Pharms
Ingredient:	edaravone
Patents:	0

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	SOLUTION;INTRAVENOUS			Strength	30MG/100ML (0.3MG/ML)
Approval Date:	Jul 22, 2026	TE:	AP	RLD:	No

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