NDA 021395

BOEHRINGER INGELHEIM

FDA Drug Application

Application #021395

Documents

• Letter: 2004-03-16
• Letter: 2006-12-28
• Letter: 2009-03-19
• Letter: 2011-08-01
• Letter: 2015-12-14
• Letter: 2016-06-24
• Label: 2004-03-03
• Label: 2006-12-14
• Label: 2009-03-19
• Label: 2006-12-14
• Label: 2009-12-18
• Label: 2011-07-29
• Label: 2015-12-15
• Review: 2004-05-06
• Other Important Information from FDA: 2004-07-13
• Letter: 2004-08-25
• Letter: 2006-09-25
• Letter: 2006-12-28
• Letter: 2008-06-25
• Letter: 2008-11-18
• Letter: 2009-12-24
• Label: 2004-08-25
• Label: 2006-09-21
• Label: 2008-11-18
• Review: 2013-06-03
• Label: 2018-02-01
• Letter: 2018-02-02

Application Sponsors

NDA 021395

BOEHRINGER INGELHEIM

Marketing Status

• Prescription: 001

Application Products

001

POWDER;INHALATION

EQ 0.018MG BASE/INH

1

SPIRIVA

TIOTROPIUM BROMIDE

FDA Submissions

TYPE 1; Type 1 - New Molecular Entity	ORIG	1	AP	2004-01-30	STANDARD
LABELING; Labeling	SUPPL	7	AP	2006-09-20	STANDARD
LABELING; Labeling	SUPPL	8	AP	2006-12-08	STANDARD
LABELING; Labeling	SUPPL	14	AP	2009-03-03	STANDARD
LABELING; Labeling	SUPPL	15	AP	2006-12-08	STANDARD
LABELING; Labeling	SUPPL	22	AP	2008-06-20	STANDARD
LABELING; Labeling	SUPPL	27	AP	2008-11-13	STANDARD
EFFICACY; Efficacy	SUPPL	29	AP	2009-12-17	STANDARD
LABELING; Labeling	SUPPL	33	AP	2011-07-28	STANDARD
LABELING; Labeling	SUPPL	34	AP	2011-11-04	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	37	AP	2015-10-26	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	38	AP	2015-04-23	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	39	AP	2015-04-22	STANDARD
LABELING; Labeling	SUPPL	40	AP	2015-12-10	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	41	AP	2016-03-24	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	42	AP	2016-04-29	STANDARD
LABELING; Labeling	SUPPL	44	AP	2016-06-23	STANDARD
LABELING; Labeling	SUPPL	48	AP	2018-02-01	STANDARD

Submissions Property Types

SUPPL	29	Null	7
SUPPL	33	Null	6
SUPPL	34	Null	6
SUPPL	37	Null	0
SUPPL	38	Null	0
SUPPL	39	Null	0
SUPPL	40	Null	6
SUPPL	41	Null	0
SUPPL	42	Null	0
SUPPL	44	Null	7
SUPPL	48	Null	31

CDER Filings

BOEHRINGER INGELHEIM

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 21395
            [companyName] => BOEHRINGER INGELHEIM
            [docInserts] => ["",""]
            [products] => [{"drugName":"SPIRIVA","activeIngredients":"TIOTROPIUM BROMIDE","strength":"EQ 0.018MG BASE\/INH","dosageForm":"POWDER;INHALATION","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"Yes"}]
            [labels] => [{"actionDate":"02\/01\/2018","submission":"SUPPL-48","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/021395s048lbl.pdf\"}]","notes":""},{"actionDate":"12\/10\/2015","submission":"SUPPL-40","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/021395s040lbl.pdf\"}]","notes":""},{"actionDate":"07\/28\/2011","submission":"SUPPL-33","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2011\\\/021395s033lbl.pdf\"}]","notes":""},{"actionDate":"12\/17\/2009","submission":"SUPPL-29","supplementCategories":"Efficacy-Labeling Change With Clinical Data","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2009\\\/021395s029lbl.pdf\"}]","notes":""},{"actionDate":"03\/03\/2009","submission":"SUPPL-14","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2009\\\/021395s014lbl.pdf\"}]","notes":""},{"actionDate":"11\/13\/2008","submission":"SUPPL-27","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2008\\\/021395s027lbl.pdf\"}]","notes":""},{"actionDate":"12\/08\/2006","submission":"SUPPL-15","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2006\\\/021395s008s015lbl.pdf\"}]","notes":""},{"actionDate":"12\/08\/2006","submission":"SUPPL-8","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2006\\\/021395s008s015lbl.pdf\"}]","notes":""},{"actionDate":"09\/20\/2006","submission":"SUPPL-7","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2006\\\/021395s007lbl.pdf\"}]","notes":""},{"actionDate":"08\/23\/2004","submission":"SUPPL-1","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2004\\\/21395s001lbl.pdf\"}]","notes":""},{"actionDate":"01\/30\/2004","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2004\\\/21395_spiriva_lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"SPIRIVA","submission":"TIOTROPIUM BROMIDE","actionType":"EQ 0.018MG BASE\/INH","submissionClassification":"POWDER;INHALATION","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"}]
            [supplements] => 
            [actionDate] => 2018-02-01
        )

)