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Generated: November 18, 2018

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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. There is one patent protecting this drug. 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:1
Pharmacology for NDA: 203971
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:RXDosage:SOLUTION;INTRAVENOUSStrength162mCi/6ML (27mCi/ML)
Approval Date:May 15, 2013TE:RLD:Yes
Regulatory Exclusivity Expiration:May 15, 2018
Regulatory Exclusivity Use:NEW CHEMICAL ENTITY
Patent:➤ Sign UpPatent Expiration:Nov 17, 2022Product Flag?Substance Flag?Delist Request?
Patented Use:THERAPEUTIC TREATMENT OF PATIENTS WITH CASTRATION-RESISTANT PROSTATE CANCER, SYMPTOMATIC BONE METASTASES AND NO KNOWN VISCERAL METASTATIC DISEASE

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