NDA 021936

BOEHRINGER INGELHEIM

FDA Drug Application

Application #021936

Documents

• Letter: 2014-09-26
• Letter: 2016-06-10
• Label: 2016-06-13
• Letter: 2016-01-20
• Label: 2014-09-26
• Label: 2016-02-17
• Review: 2015-07-02
• Summary Review: 2015-07-02
• Label: 2017-02-16
• Pediatric Medical Review: 1900-01-01
• Pediatric Clinical Pharmacology Review: 1900-01-01
• Pediatric Statistical Review: 1900-01-01
• Pediatric Written Request: 1900-01-01
• Label: 2019-02-19
• Letter: 2019-02-21

Application Sponsors

NDA 021936

BOEHRINGER INGELHEIM

Marketing Status

• Prescription: 001
• Prescription: 002

Application Products

001	SPRAY, METERED;INHALATION	EQ 0.0025MG BASE/INH	1	SPIRIVA RESPIMAT	TIOTROPIUM BROMIDE
002	SPRAY, METERED;INHALATION	EQ 0.00125MG BASE/INH	1	SPIRIVA RESPIMAT	TIOTROPIUM BROMIDE

FDA Submissions

TYPE 3; Type 3 - New Dosage Form	ORIG	1	AP	2014-09-24	STANDARD
LABELING; Labeling	SUPPL	3	AP	2016-01-15	STANDARD
LABELING; Labeling	SUPPL	5	AP	2016-06-09	STANDARD
EFFICACY; Efficacy	SUPPL	7	AP	2017-02-15	PRIORITY
LABELING; Labeling	SUPPL	12	AP	2019-02-14	STANDARD

Submissions Property Types

ORIG	1	Null	7
SUPPL	3	Null	15
SUPPL	5	Null	6
SUPPL	7	Null	15
SUPPL	12	Null	15

CDER Filings

BOEHRINGER INGELHEIM

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 21936
            [companyName] => BOEHRINGER INGELHEIM
            [docInserts] => ["",""]
            [products] => [{"drugName":"SPIRIVA RESPIMAT","activeIngredients":"TIOTROPIUM BROMIDE","strength":"EQ 0.0025MG BASE\/INH","dosageForm":"SPRAY, METERED;INHALATION","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"Yes"},{"drugName":"SPIRIVA RESPIMAT","activeIngredients":"TIOTROPIUM BROMIDE","strength":"EQ 0.00125MG BASE\/INH","dosageForm":"SPRAY, METERED;INHALATION","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"No"}]
            [labels] => [{"actionDate":"02\/14\/2019","submission":"SUPPL-12","supplementCategories":"Labeling-Container\/Carton Labels","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/021936s012lbl.pdf\"}]","notes":""},{"actionDate":"02\/15\/2017","submission":"SUPPL-7","supplementCategories":"Efficacy-New Patient Population","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/021936s007lbl.pdf\"}]","notes":""},{"actionDate":"06\/09\/2016","submission":"SUPPL-5","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/021936s005lbl.pdf\"}]","notes":""},{"actionDate":"01\/15\/2016","submission":"SUPPL-3","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/021936s003lbl.pdf\"}]","notes":""},{"actionDate":"09\/24\/2014","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/021936s000lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"SPIRIVA RESPIMAT","submission":"TIOTROPIUM BROMIDE","actionType":"EQ 0.0025MG BASE\/INH","submissionClassification":"SPRAY, METERED;INHALATION","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"},{"actionDate":"SPIRIVA RESPIMAT","submission":"TIOTROPIUM BROMIDE","actionType":"EQ 0.00125MG BASE\/INH","submissionClassification":"SPRAY, METERED;INHALATION","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"}]
            [supplements] => 
            [actionDate] => 2019-02-14
        )

)