BAYER HLTHCARE FDA Approval NDA 203971

NDA 203971

BAYER HLTHCARE

FDA Drug Application

Application #203971

Documents

Letter2016-03-22
Label2013-05-15
Label2016-03-22
Summary Review2013-06-21
Letter2013-05-16
Review2013-06-21
Label2018-02-02
Letter2018-02-08
Label2018-09-05
Letter2018-09-13
Letter2019-12-11
Label2019-12-11

Application Sponsors

NDA 203971BAYER HLTHCARE

Marketing Status

Prescription001

Application Products

001SOLUTION;INTRAVENOUS162mCi/6ML (27mCi/ML)1XOFIGORADIUM RA-223 DICHLORIDE

FDA Submissions

TYPE 1; Type 1 - New Molecular EntityORIG1AP2013-05-15PRIORITY
MANUF (CMC); Manufacturing (CMC)SUPPL5AP2015-05-12PRIORITY
MANUF (CMC); Manufacturing (CMC)SUPPL6AP2015-09-10PRIORITY
LABELING; LabelingSUPPL7AP2016-03-18STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL8AP2016-01-22PRIORITY
MANUF (CMC); Manufacturing (CMC)SUPPL9AP2016-04-29PRIORITY
MANUF (CMC); Manufacturing (CMC)SUPPL10AP2016-05-12PRIORITY
LABELING; LabelingSUPPL12AP2018-02-02STANDARD
LABELING; LabelingSUPPL14AP2018-08-31STANDARD
LABELING; LabelingSUPPL16AP2019-12-10STANDARD

Submissions Property Types

ORIG1Null6
SUPPL5Null0
SUPPL6Null0
SUPPL7Null15
SUPPL8Null0
SUPPL9Null0
SUPPL10Null0
SUPPL12Null7
SUPPL14Null7
SUPPL16Null7

CDER Filings

BAYER HLTHCARE
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 203971
            [companyName] => BAYER HLTHCARE
            [docInserts] => ["",""]
            [products] => [{"drugName":"XOFIGO","activeIngredients":"RADIUM RA-223 DICHLORIDE","strength":"162mCi\/6ML (27mCi\/ML)","dosageForm":"SOLUTION;INTRAVENOUS","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"Yes"}]
            [labels] => [{"actionDate":"12\/10\/2019","submission":"SUPPL-16","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/203971s016lbl.pdf\"}]","notes":""},{"actionDate":"08\/31\/2018","submission":"SUPPL-14","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/203971s014lbl.pdf\"}]","notes":""},{"actionDate":"02\/02\/2018","submission":"SUPPL-12","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/203971s012lbl.pdf\"}]","notes":""},{"actionDate":"03\/18\/2016","submission":"SUPPL-7","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/203971s007lbl.pdf\"}]","notes":""},{"actionDate":"05\/15\/2013","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2013\\\/203971lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"05\/15\/2013","submission":"ORIG-1","actionType":"Approval","submissionClassification":"Type 1 - New Molecular Entity","reviewPriority":"PRIORITY","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2013\\\/203971lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2013\\\/203971Orig1s000ltr.pdf\"},{\"name\":\"Review\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2013\\\/203971Orig1s000TOC.cfm\"},{\"name\":\"Summary Review (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2013\\\/203971Orig1s000SumR.pdf\"}]","notes":">"}]
            [supplements] => [{"actionDate":"12\/10\/2019","submission":"SUPPL-16","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/203971s016lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2019\\\/203971Orig1s016ltr.pdf\"}]","notes":">"},{"actionDate":"08\/31\/2018","submission":"SUPPL-14","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/203971s014lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2018\\\/203971Orig1s014ltr.pdf\"}]","notes":">"},{"actionDate":"02\/02\/2018","submission":"SUPPL-12","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/203971s012lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2018\\\/203971Orig1s012ltr.pdf\"}]","notes":">"},{"actionDate":"05\/12\/2016","submission":"SUPPL-10","supplementCategories":"Manufacturing (CMC)","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"04\/29\/2016","submission":"SUPPL-9","supplementCategories":"Manufacturing (CMC)","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"01\/22\/2016","submission":"SUPPL-8","supplementCategories":"Manufacturing (CMC)","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"03\/18\/2016","submission":"SUPPL-7","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/203971s007lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2016\\\/203971Orig1s007ltr.pdf\"}]","notes":">"},{"actionDate":"09\/10\/2015","submission":"SUPPL-6","supplementCategories":"Manufacturing (CMC)","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"05\/12\/2015","submission":"SUPPL-5","supplementCategories":"Manufacturing (CMC)","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"02\/16\/2015","submission":"SUPPL-1","supplementCategories":"Manufacturing (CMC)","inserts":"[]","notes":"> Label is not available on this site."}]
            [actionDate] => 2019-12-10
        )

)
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