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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 NDA: 203971

Bayer Hlthcare
radium ra-223 dichloride

Pharmacology for NDA: 203971

Suppliers and Packaging for NDA: 203971

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
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)

Summary 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:6,635,234Patent Expiration:Jan 3, 2020Product Flag?Substance Flag?Delist Request?

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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.