RADIUM CHLORIDE RA-223 Injectable Solution

Brand(s)
Xofigo
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Bayer Healthcare Pharmaceuticals Inc. (2013-05-15)
Oldest Current Product
2013-05-20
License(s)
NDA
RxNORM
INJECTABLE SOLUTION\RADIUM CHLORIDE RA-223
FDAOB
INTRAVENOUS\SOLUTION\RADIUM RA-223 DICHLORIDE
SPL Active
INTRAVENOUS\INJECTION\RADIUM RA-223 DICHLORIDE
SPL Moiety
INTRAVENOUS\INJECTION\RADIUM

product(s) by strength(s)

radium chloride ra-223 27 mci/ml injectable solution

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1504190208XofigoNDABayer Healthcare Pharmaceuticals Inc.2013-05-20RADIUM RA-223 DICHLORIDEINTRAVENOUSINJECTIONNDA203971a398400e-bd31-41a9-9696-4f7c06569ede

application(s)

#idtitleapplicantapprovedpatentexclusivityapproved drug
1NDA203971XOFIGOBAYER HEALTHCARE PHARMACEUTICALS INC2013-05-15p6635234, THERAPEUTIC TREATMENT OF BONE METASTASESNEW CHEMICAL ENTITY [2018-05-15]NDA203971_001

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldapprovedapplication
1NDA203971_001RXRADIUM RA-223 DICHLORIDE (162mCi/6ML)INTRAVENOUSSOLUTIONTrue2013-05-15XOFIGO

patent(s)

#idexpiration dateapplication(s)
1p6635234 (view patent)2020-01-03NDA203971

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
1a398400e-bd31-41a9-9696-4f7c06569ede (view SPL)These highlights do not include all the information needed to use XOFIGO safely and effectively. See full prescribing information for XOFIGO. Xofigo (radium Ra 223 dichloride) Injection, for intravenous use Initial U.S. Approval: 2013prescriptionHuman PrescriptionBayer Healthcare Pharmaceuticals Inc.LABEL, MANUFACTURE2013-05-151504190208

Data from: FDAOB, FDAPB, LOINC, MTHSPL, NDFRT, NCIT, RxNORM, UNII