Last Updated: September 24, 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 four 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. Five 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

Suppliers and Packaging for NDA: 217565

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
EDARAVONE	edaravone	SOLUTION;INTRAVENOUS	217565	ANDA	XGen Pharmaceuticals DJB, Inc.	39822-4510	39822-4510-1	1 VIAL, SINGLE-DOSE in 1 CARTON (39822-4510-1) / 100 mL in 1 VIAL, SINGLE-DOSE

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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