Details for New Drug Application (NDA): 215446

NDA 215446 describes RADICAVA ORS, which is a drug marketed by Mitsubishi Tanabe and is included in one NDA. It is available from one supplier. There are five patents protecting this drug. Additional details are available on the RADICAVA ORS profile page.

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

Summary for 215446

Tradename:	RADICAVA ORS
Applicant:	Mitsubishi Tanabe
Ingredient:	edaravone
Patents:	5

Suppliers and Packaging for NDA: 215446

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
RADICAVA ORS	edaravone	SUSPENSION;ORAL	215446	NDA	Mitsubishi Tanabe Pharma America, Inc.	70510-2321	70510-2321-2	2 CARTON in 1 CARTON (70510-2321-2) / 1 KIT in 1 CARTON (70510-2321-1) * 1 BOTTLE in 1 KIT (70510-2323-1) / 35 mL in 1 BOTTLE
RADICAVA ORS	edaravone	SUSPENSION;ORAL	215446	NDA	Mitsubishi Tanabe Pharma America, Inc.	70510-2322	70510-2322-1	1 KIT in 1 CARTON (70510-2322-1) * 50 mL in 1 BOTTLE (70510-2324-1)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	SUSPENSION;ORAL			Strength	105MG/5ML
Approval Date:	May 12, 2022	TE:		RLD:	Yes
Regulatory Exclusivity Expiration:	May 12, 2025
Regulatory Exclusivity Use:	NEW PRODUCT
Regulatory Exclusivity Expiration:	May 12, 2029
Regulatory Exclusivity Use:	TREATMENT OF AMYOTROPHIC LATERAL SCLEROSIS (ALS)
Patent:	10,987,341	Patent Expiration:	Nov 1, 2039	Product Flag?	Y	Substance Flag?		Delist Request?

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