Details for New Drug Application (NDA): 209176

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NDA 209176 describes RADICAVA, which is a drug marketed by Mitsubishi Tanabe and is included in two NDAs. It is available from one supplier. There are five patents protecting this drug. Additional details are available on the RADICAVA profile page.

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

Summary for 209176

Tradename:	RADICAVA
Applicant:	Mitsubishi Tanabe
Ingredient:	edaravone
Patents:	0

Suppliers and Packaging for NDA: 209176

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
RADICAVA	edaravone	SOLUTION;INTRAVENOUS	209176	NDA	Mitsubishi Tanabe Pharma America, Inc.	70510-2171	70510-2171-2	2 BAG in 1 CARTON (70510-2171-2) / 100 mL in 1 BAG (70510-2171-1)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	SOLUTION;INTRAVENOUS			Strength	30MG/100ML (0.3MG/ML)
Approval Date:	May 5, 2017	TE:	AP	RLD:	Yes
Regulatory Exclusivity Expiration:	May 5, 2024
Regulatory Exclusivity Use:	TREATMENT OF AMYOTROPHIC LATERAL SCLEROSIS (ALS)

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	SOLUTION;INTRAVENOUS			Strength	60MG/100ML (0.6MG/ML)
Approval Date:	Nov 15, 2018	TE:	AP	RLD:	Yes
Regulatory Exclusivity Expiration:	May 5, 2024
Regulatory Exclusivity Use:	FDA HAS NOT RECOGNIZED ORPHAN-DRUG EXCLUSIVITY (ODE) FOR THIS DRUG, BUT IT CONTAINS THE SAME ACTIVE MOIETY OR MOIETIES AS ANOTHER DRUG(S) THAT WAS ELIGIBLE FOR ODE, AND ALSO SHARES ODE-PROTECTED USE(S) OR INDICATION(S) WITH THAT DRUG(S).AN APPLICATION SEEKING APPROVAL FOR THE SAME ACTIVE MOIETY OR MOIETIES, INCLUDING AN ANDA THAT CITES THIS NDA AS ITS BASIS OF SUBMISSION, MAY NOT BE APPROVED FOR SUCH ODE-PROTECTED USE(S) AND INDICATION(S)

Expired US Patents for NDA 209176

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Mitsubishi Tanabe	RADICAVA	edaravone	SOLUTION;INTRAVENOUS	209176-001	May 5, 2017	⤷ Sign Up	⤷ Sign Up
Mitsubishi Tanabe	RADICAVA	edaravone	SOLUTION;INTRAVENOUS	209176-002	Nov 15, 2018	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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