Last Updated: November 13, 2026

Details for New Drug Application (NDA): 216199

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NDA 216199 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 216199

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

Suppliers and Packaging for NDA: 216199

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
EDARAVONE	edaravone	SOLUTION;INTRAVENOUS	216199	ANDA	Piramal Critical Care Inc.	66794-259	66794-259-64	2 POUCH in 1 CARTON (66794-259-64) / 1 BAG in 1 POUCH / 100 mL in 1 BAG
EDARAVONE	edaravone	SOLUTION;INTRAVENOUS	216199	ANDA	Gland Pharma Limited	68083-500	68083-500-02	2 POUCH in 1 CARTON (68083-500-02) / 1 BAG in 1 POUCH / 100 mL in 1 BAG

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	SOLUTION;INTRAVENOUS			Strength	30MG/100ML (0.3MG/ML)
Approval Date:	May 6, 2024	TE:	AP	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	DISCN	Dosage:	SOLUTION;INTRAVENOUS			Strength	60MG/100ML (0.6MG/ML)
Approval Date:	May 6, 2024	TE:		RLD:	No

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