NDA 203108

BOEHRINGER INGELHEIM

FDA Drug Application

Application #203108

Documents

• Letter: 2016-06-10
• Label: 2016-06-13
• Review: 2014-09-08
• Summary Review: 2014-09-08
• Letter: 2014-08-01
• Label: 2014-08-01
• Medication Guide: 2018-02-28
• Label: 2018-04-03
• Letter: 2018-04-05
• Label: 2019-05-31
• Letter: 2019-06-04

Application Sponsors

NDA 203108

BOEHRINGER INGELHEIM

Marketing Status

• Prescription: 001

Application Products

001

SPRAY, METERED;INHALATION

EQ 0.0025MG BASE/INH

1

STRIVERDI RESPIMAT

OLODATEROL HYDROCHLORIDE

FDA Submissions

TYPE 1; Type 1 - New Molecular Entity	ORIG	1	AP	2014-07-31	STANDARD
LABELING; Labeling	SUPPL	3	AP	2016-06-09	STANDARD
LABELING; Labeling	SUPPL	6	AP	2018-04-02	STANDARD
LABELING; Labeling	SUPPL	8	AP	2019-05-29	STANDARD

Submissions Property Types

ORIG	1	Null	6
SUPPL	3	Null	15
SUPPL	6	Null	6
SUPPL	8	Null	6

CDER Filings

BOEHRINGER INGELHEIM

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 203108
            [companyName] => BOEHRINGER INGELHEIM
            [docInserts] => ["Medication Guide",""]
            [products] => [{"drugName":"STRIVERDI RESPIMAT","activeIngredients":"OLODATEROL HYDROCHLORIDE","strength":"EQ 0.0025MG BASE\/INH","dosageForm":"SPRAY, METERED;INHALATION","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"Yes"}]
            [labels] => [{"actionDate":"05\/29\/2019","submission":"SUPPL-8","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/203108s008lbl.pdf\"}]","notes":""},{"actionDate":"04\/02\/2018","submission":"SUPPL-6","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/203108s006lbl.pdf\"}]","notes":""},{"actionDate":"06\/09\/2016","submission":"SUPPL-3","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/203108s003lbl.pdf\"}]","notes":""},{"actionDate":"07\/31\/2014","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/203108s000lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"07\/31\/2014","submission":"ORIG-1","actionType":"Approval","submissionClassification":"Type 1 - New Molecular Entity","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/203108s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2014\\\/203108Orig1s000ltr.pdf\"},{\"name\":\"Review\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2014\\\/203108Orig1s000TOC.cfm\"},{\"name\":\"Summary Review (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2014\\\/203108Orig1s000SumR.pdf\"}]","notes":">"}]
            [supplements] => [{"actionDate":"05\/29\/2019","submission":"SUPPL-8","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/203108s008lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2019\\\/203108Orig1s008ltr.pdf\"}]","notes":">"},{"actionDate":"04\/02\/2018","submission":"SUPPL-6","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/203108s006lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2018\\\/203108Orig1s006ltr.pdf\"}]","notes":">"},{"actionDate":"06\/09\/2016","submission":"SUPPL-3","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/203108s003lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2016\\\/203108Orig1s003ltr.pdf\"}]","notes":">"}]
            [actionDate] => 2019-05-29
        )

)