Details for New Drug Application (NDA): 203971

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NDA 203971 describes XOFIGO, which is a drug marketed by Bayer Hlthcare and is included in one NDA. It is available from one supplier. Additional details are available on the XOFIGO profile page.

The generic ingredient in XOFIGO is radium ra-223 dichloride. One supplier is listed for this compound. Additional details are available on the radium ra-223 dichloride profile page.

Summary for 203971

Tradename:	XOFIGO
Applicant:	Bayer Hlthcare
Ingredient:	radium ra-223 dichloride
Patents:	0

Pharmacology for NDA: 203971

Mechanism of Action	alpha-Particle Emitting Activity

Suppliers and Packaging for NDA: 203971

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
XOFIGO	radium ra-223 dichloride	SOLUTION;INTRAVENOUS	203971	NDA	Bayer HealthCare Pharmaceuticals Inc.	50419-208	50419-208-01	6 mL in 1 VIAL, SINGLE-DOSE (50419-208-01)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	SOLUTION;INTRAVENOUS			Strength	162mCi/6ML (27mCi/ML)
Approval Date:	May 15, 2013	TE:		RLD:	Yes

Expired US Patents for NDA 203971

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Bayer Hlthcare	XOFIGO	radium ra-223 dichloride	SOLUTION;INTRAVENOUS	203971-001	May 15, 2013	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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