Last Updated: September 24, 2026

Details for New Drug Application (NDA): 216902

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NDA 216902 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 216902

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

Suppliers and Packaging for NDA: 216902

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
EDARAVONE	edaravone	SOLUTION;INTRAVENOUS	216902	ANDA	Sandoz Inc	0781-3527	0781-3527-20	2 BAG in 1 CARTON (0781-3527-20) / 100 mL in 1 BAG (0781-3527-94)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	SOLUTION;INTRAVENOUS			Strength	30MG/100ML (0.3MG/ML)
Approval Date:	Dec 23, 2024	TE:	AP	RLD:	No

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