BAYER HLTHCARE FDA Approval NDA 021923

NDA 021923

BAYER HLTHCARE

FDA Drug Application

Application #021923

Documents

Letter2007-03-15
Letter2007-11-26
Letter2007-11-26
Letter2007-11-26
Letter2010-11-03
Letter2011-03-25
Letter2012-08-27
Letter2013-06-12
Letter2013-11-25
Label2007-11-19
Label2010-10-28
Label2011-03-28
Label2011-10-20
Label2013-06-18
Label2013-10-31
Review2006-02-08
Letter2006-01-19
Letter2007-11-26
Letter2010-11-03
Letter2011-10-17
Letter2013-10-31
Label2006-01-06
Label2007-11-19
Label2007-11-19
Label2007-11-19
Label2010-10-28
Label2013-11-22
Letter2017-12-27
Label2017-12-27
Label2018-12-07
Label2018-12-07
Letter2018-12-07
Letter2018-12-07
Letter2020-04-03
Label2020-04-10
Label2020-06-23
Letter2020-06-23
Label2020-07-10
Letter2020-07-10
Letter2021-05-24
Label2021-06-03

Application Sponsors

NDA 021923BAYER HLTHCARE

Marketing Status

Prescription001

Application Products

001TABLET;ORALEQ 200MG BASE1NEXAVARSORAFENIB TOSYLATE

FDA Submissions

TYPE 1; Type 1 - New Molecular EntityORIG1AP2005-12-01PRIORITY
LABELING; LabelingSUPPL3AP2007-03-05STANDARD
EFFICACY; EfficacySUPPL4AP2007-11-16PRIORITY
EFFICACY; EfficacySUPPL5AP2007-11-16PRIORITY
EFFICACY; EfficacySUPPL6AP2007-11-16PRIORITY
EFFICACY; EfficacySUPPL7AP2007-11-16PRIORITY
LABELING; LabelingSUPPL8AP2010-10-26STANDARD
LABELING; LabelingSUPPL9AP2010-10-26UNKNOWN
LABELING; LabelingSUPPL11AP2011-03-22STANDARD
LABELING; LabelingSUPPL12AP2011-10-14STANDARD
LABELING; LabelingSUPPL13AP2012-08-24STANDARD
LABELING; LabelingSUPPL14AP2013-06-11STANDARD
LABELING; LabelingSUPPL15AP2013-10-30STANDARD
EFFICACY; EfficacySUPPL16AP2013-11-22PRIORITY
MANUF (CMC); Manufacturing (CMC)SUPPL17AP2014-12-02PRIORITY
EFFICACY; EfficacySUPPL18AP2017-12-22STANDARD
LABELING; LabelingSUPPL19AP2018-12-06STANDARD
LABELING; LabelingSUPPL20AP2018-12-06STANDARD
LABELING; LabelingSUPPL22AP2020-06-19STANDARD
LABELING; LabelingSUPPL23AP2020-04-02STANDARD
LABELING; LabelingSUPPL24AP2020-07-09STANDARD
LABELING; LabelingSUPPL25AP2021-05-20STANDARD

Submissions Property Types

ORIG1Orphan5
SUPPL4Null14
SUPPL5Null14
SUPPL6Null14
SUPPL8Null6
SUPPL9Null6
SUPPL11Null6
SUPPL12Null6
SUPPL13Null6
SUPPL14Null7
SUPPL15Null15
SUPPL16Null6
SUPPL17Null14
SUPPL18Null7
SUPPL19Null7
SUPPL20Null31
SUPPL22Null7
SUPPL23Null7
SUPPL24Null6
SUPPL25Orphan5

TE Codes

001PrescriptionAB

CDER Filings

BAYER HLTHCARE
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 21923
            [companyName] => BAYER HLTHCARE
            [docInserts] => ["",""]
            [products] => [{"drugName":"NEXAVAR","activeIngredients":"SORAFENIB TOSYLATE","strength":"EQ 200MG BASE","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"Yes"}]
            [labels] => [{"actionDate":"07\/09\/2020","submission":"SUPPL-24","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/021923s024lbl.pdf\"}]","notes":""},{"actionDate":"06\/19\/2020","submission":"SUPPL-22","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/021923s022lbl.pdf\"}]","notes":""},{"actionDate":"06\/19\/2020","submission":"SUPPL-22","supplementCategories":"Labeling-Patient Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/021923s022lbl.pdf\"}]","notes":""},{"actionDate":"04\/02\/2020","submission":"SUPPL-23","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/021923s023lbl.pdf\"}]","notes":""},{"actionDate":"12\/06\/2018","submission":"SUPPL-20","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/021923s020lbl.pdf\"}]","notes":""},{"actionDate":"12\/06\/2018","submission":"SUPPL-19","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/021923s019lbl.pdf\"}]","notes":""},{"actionDate":"12\/22\/2017","submission":"SUPPL-18","supplementCategories":"Efficacy-Labeling Change With Clinical Data","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/021923s018lbl.pdf\"}]","notes":""},{"actionDate":"11\/22\/2013","submission":"SUPPL-16","supplementCategories":"Efficacy-New Indication","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2013\\\/021923s016lbl.pdf\"}]","notes":""},{"actionDate":"10\/30\/2013","submission":"SUPPL-15","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2013\\\/021923s015lbl.pdf\"}]","notes":""},{"actionDate":"06\/11\/2013","submission":"SUPPL-14","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2013\\\/021923s014lbl.pdf\"}]","notes":""},{"actionDate":"10\/14\/2011","submission":"SUPPL-12","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2011\\\/021923s012lbl.pdf\"}]","notes":""},{"actionDate":"10\/14\/2011","submission":"SUPPL-12","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2011\\\/021923s012lbl.pdf\"}]","notes":""},{"actionDate":"03\/22\/2011","submission":"SUPPL-11","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2011\\\/021923s011lbl.pdf\"}]","notes":""},{"actionDate":"10\/26\/2010","submission":"SUPPL-9","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2010\\\/021923s008s009lbl.pdf\"}]","notes":""},{"actionDate":"10\/26\/2010","submission":"SUPPL-8","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2010\\\/021923s008s009lbl.pdf\"}]","notes":""},{"actionDate":"11\/16\/2007","submission":"SUPPL-7","supplementCategories":"Efficacy-New Indication","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2007\\\/021923s004s005s006s007lbl.pdf\"}]","notes":""},{"actionDate":"11\/16\/2007","submission":"SUPPL-6","supplementCategories":"Efficacy-New Indication","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2007\\\/021923s004s005s006s007lbl.pdf\"}]","notes":""},{"actionDate":"11\/16\/2007","submission":"SUPPL-5","supplementCategories":"Efficacy-New Indication","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2007\\\/021923s004s005s006s007lbl.pdf\"}]","notes":""},{"actionDate":"11\/16\/2007","submission":"SUPPL-4","supplementCategories":"Efficacy-New Indication","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2007\\\/021923s004s005s006s007lbl.pdf\"}]","notes":""},{"actionDate":"12\/01\/2005","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2005\\\/021923lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"NEXAVAR","submission":"SORAFENIB TOSYLATE","actionType":"EQ 200MG BASE","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"}]
            [supplements] => 
            [actionDate] => 2020-07-09
        )

)
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