BOEHRINGER INGELHEIM FDA Approval NDA 206756

NDA 206756

BOEHRINGER INGELHEIM

FDA Drug Application

Application #206756

Documents

Letter2015-06-18
Letter2016-06-10
Label2015-05-21
Label2015-06-19
Label2016-03-22
Label2016-06-13
Letter2015-05-21
Letter2016-03-22
Review2016-06-27
Medication Guide2017-02-17
Label2018-10-05
Letter2018-10-15
Label2019-05-31
Letter2019-06-04

Application Sponsors

NDA 206756BOEHRINGER INGELHEIM

Marketing Status

Prescription001

Application Products

001SPRAY, METERED;INHALATIONEQ 0.0025MG BASE/INH;EQ 0.0025MG BASE/INH1STIOLTO RESPIMATOLODATEROL HYDROCHLORIDE; TIOTROPIUM BROMIDE

FDA Submissions

TYPE 1/4; Type 1 - New Molecular Entity and Type 4 - New CombinationORIG1AP2015-05-21STANDARD
EFFICACY; EfficacySUPPL2AP2016-03-18STANDARD
LABELING; LabelingSUPPL6AP2016-06-09STANDARD
EFFICACY; EfficacySUPPL9AP2018-10-05STANDARD
LABELING; LabelingSUPPL11AP2019-05-29STANDARD

Submissions Property Types

ORIG1Null6
SUPPL2Null7
SUPPL6Null15
SUPPL9Null7
SUPPL11Null7

CDER Filings

BOEHRINGER INGELHEIM
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 206756
            [companyName] => BOEHRINGER INGELHEIM
            [docInserts] => ["",""]
            [products] => [{"drugName":"STIOLTO RESPIMAT","activeIngredients":"OLODATEROL HYDROCHLORIDE; TIOTROPIUM BROMIDE","strength":"EQ 0.0025MG BASE\/INH;EQ 0.0025MG BASE\/INH","dosageForm":"SPRAY, METERED;INHALATION","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"Yes"}]
            [labels] => [{"actionDate":"05\/29\/2019","submission":"SUPPL-11","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/206756s011lbl.pdf\"}]","notes":""},{"actionDate":"10\/05\/2018","submission":"SUPPL-9","supplementCategories":"Efficacy-Labeling Change With Clinical Data","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/206756s009lbl.pdf\"}]","notes":""},{"actionDate":"06\/09\/2016","submission":"SUPPL-6","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/206756s006lbl.pdf\"}]","notes":""},{"actionDate":"03\/18\/2016","submission":"SUPPL-2","supplementCategories":"Efficacy-Labeling Change With Clinical Data","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/206756s002lbl.pdf\"}]","notes":""},{"actionDate":"06\/16\/2015","submission":"SUPPL-1","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/206756s001lbl.pdf\"}]","notes":""},{"actionDate":"05\/21\/2015","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/206756Orig1s000lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"05\/21\/2015","submission":"ORIG-1","actionType":"Approval","submissionClassification":"Type 4 - New Combination","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/206756Orig1s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2015\\\/206756Orig1s000ltr.pdf\"},{\"name\":\"Review\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2015\\\/206756Orig1s000TOC.cfm\"}]","notes":">"}]
            [supplements] => [{"actionDate":"05\/29\/2019","submission":"SUPPL-11","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/206756s011lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2019\\\/206756Orig1s011ltr.pdf\"}]","notes":">"},{"actionDate":"10\/05\/2018","submission":"SUPPL-9","supplementCategories":"Efficacy-Labeling Change With Clinical Data","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/206756s009lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2018\\\/206756Orig1s009ltr.pdf\"}]","notes":">"},{"actionDate":"06\/09\/2016","submission":"SUPPL-6","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/206756s006lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2016\\\/206756Orig1s006ltr.pdf\"}]","notes":">"},{"actionDate":"03\/18\/2016","submission":"SUPPL-2","supplementCategories":"Efficacy-Labeling Change With Clinical Data","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/206756s002lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2016\\\/206756Orig1s002ltr.pdf\"}]","notes":">"},{"actionDate":"06\/16\/2015","submission":"SUPPL-1","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/206756s001lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2015\\\/206756Orig1s001ltr.pdf\"}]","notes":">"}]
            [actionDate] => 2019-05-29
        )

)
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