Details for New Drug Application (NDA): 215508

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NDA 215508 describes EDARAVONE, which is a drug marketed by Dr Reddys, Gland Pharma Ltd, Hikma, Long Grove Pharms, and Xgen Pharms, and is included in five NDAs. It is available from four suppliers. Additional details are available on the EDARAVONE profile page.

The generic ingredient in EDARAVONE is edaravone. Five suppliers are listed for this compound. Additional details are available on the edaravone profile page.

Summary for 215508

Tradename:	EDARAVONE
Applicant:	Hikma
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:	May 6, 2024	TE:	AP	RLD:	No

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