BOEHRINGER INGELHEIM FDA Approval NDA 021814

NDA 021814

BOEHRINGER INGELHEIM

FDA Drug Application

Application #021814

Documents

Letter2007-05-29
Letter2009-06-24
Letter2010-09-07
Letter2011-04-07
Letter2015-04-01
Label2006-08-14
Label2007-10-10
Label2010-08-16
Label2011-04-06
Review2005-09-02
Review2010-05-12
Summary Review2010-05-12
Letter2005-06-24
Letter2006-08-18
Letter2006-08-18
Letter2007-10-10
Letter2008-06-26
Letter2010-05-03
Letter2012-02-27
Letter2014-04-08
Label2005-06-23
Label2006-08-14
Label2008-06-26
Label2009-06-24
Label2010-05-07
Label2012-02-22
Label2014-04-08
Label2015-04-07
Letter2016-09-20
Label2016-09-23
Pediatric Medical Review1900-01-01
Pediatric Clinical Pharmacology Review1900-01-01
Pediatric Statistical Review1900-01-01
Label2018-06-28
Letter2018-07-06
Letter2020-06-19
Label2020-06-22

Application Sponsors

NDA 021814BOEHRINGER INGELHEIM

Marketing Status

Prescription001

Application Products

001CAPSULE;ORAL250MG1APTIVUSTIPRANAVIR

FDA Submissions

TYPE 1; Type 1 - New Molecular EntityORIG1AP2005-06-22PRIORITY
LABELING; LabelingSUPPL2AP2006-08-11STANDARD
EFFICACY; EfficacySUPPL3AP2007-10-04UNKNOWN
LABELING; LabelingSUPPL4AP2007-05-14STANDARD
EFFICACY; EfficacySUPPL5AP2008-06-23PRIORITY
LABELING; LabelingSUPPL6AP2009-06-19STANDARD
LABELING; LabelingSUPPL8AP2010-04-27UNKNOWN
LABELING; LabelingSUPPL9AP2010-08-16STANDARD
LABELING; LabelingSUPPL11AP2011-04-05STANDARD
LABELING; LabelingSUPPL13AP2012-02-17901 REQUIRED
LABELING; LabelingSUPPL14AP2014-04-07STANDARD
LABELING; LabelingSUPPL15AP2015-03-27901 ORDER
LABELING; LabelingSUPPL16AP2016-09-15901 REQUIRED
LABELING; LabelingSUPPL18AP2018-06-22STANDARD
LABELING; LabelingSUPPL21AP2020-06-18STANDARD

Submissions Property Types

ORIG1Null41
SUPPL5Null6
SUPPL8Null6
SUPPL9Null6
SUPPL11Null31
SUPPL13Null15
SUPPL14Null15
SUPPL15Null6
SUPPL16Null7
SUPPL18Null7
SUPPL21Null15

CDER Filings

BOEHRINGER INGELHEIM
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 21814
            [companyName] => BOEHRINGER INGELHEIM
            [docInserts] => ["",""]
            [products] => [{"drugName":"APTIVUS","activeIngredients":"TIPRANAVIR","strength":"250MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"Yes"}]
            [labels] => [{"actionDate":"06\/18\/2020","submission":"SUPPL-21","supplementCategories":"Labeling-Patient Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/021814s021,022292s014lbl.pdf\"}]","notes":""},{"actionDate":"06\/18\/2020","submission":"SUPPL-21","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/021814s021,022292s014lbl.pdf\"}]","notes":""},{"actionDate":"06\/22\/2018","submission":"SUPPL-18","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/021814s018lbl.pdf\"}]","notes":""},{"actionDate":"06\/22\/2018","submission":"SUPPL-18","supplementCategories":"Labeling-Patient Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/021814s018lbl.pdf\"}]","notes":""},{"actionDate":"09\/15\/2016","submission":"SUPPL-16","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/021814s016,022292s009lbl.pdf\"}]","notes":""},{"actionDate":"03\/27\/2015","submission":"SUPPL-15","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/021814s015,022292s008lbl.pdf\"}]","notes":""},{"actionDate":"03\/27\/2015","submission":"SUPPL-15","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/021814s015,022292s008lbl.pdf\"}]","notes":""},{"actionDate":"04\/07\/2014","submission":"SUPPL-14","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/021814s014,022292s007lbl.pdf\"}]","notes":""},{"actionDate":"02\/17\/2012","submission":"SUPPL-13","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2012\\\/021814s013,022292s006lbl.pdf\"}]","notes":""},{"actionDate":"04\/05\/2011","submission":"SUPPL-11","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2011\\\/021814s011lbl.pdf\"}]","notes":""},{"actionDate":"08\/16\/2010","submission":"SUPPL-9","supplementCategories":"Labeling-Container\/Carton Labels","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2010\\\/021814s009lbl.pdf\"}]","notes":""},{"actionDate":"04\/27\/2010","submission":"SUPPL-8","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2010\\\/021814s008,022292s002lbl.pdf\"}]","notes":""},{"actionDate":"06\/19\/2009","submission":"SUPPL-6","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2009\\\/021814s006,022292s001lbl.pdf\"}]","notes":""},{"actionDate":"06\/23\/2008","submission":"SUPPL-5","supplementCategories":"Efficacy-New Indication","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2008\\\/021814s005,022292lbl.pdf\"}]","notes":""},{"actionDate":"10\/04\/2007","submission":"SUPPL-3","supplementCategories":"Efficacy-Accelerated Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2007\\\/021814s003lbl.pdf\"}]","notes":""},{"actionDate":"08\/11\/2006","submission":"SUPPL-2","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2006\\\/021814s001s002lbl.pdf\"}]","notes":""},{"actionDate":"08\/11\/2006","submission":"SUPPL-1","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2006\\\/021814s001s002lbl.pdf\"}]","notes":""},{"actionDate":"06\/22\/2005","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2005\\\/021814lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"APTIVUS","submission":"TIPRANAVIR","actionType":"250MG","submissionClassification":"CAPSULE;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"}]
            [supplements] => 
            [actionDate] => 2020-06-18
        )

)
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