NDA 021527

BOEHRINGER INGELHEIM

FDA Drug Application

Application #021527

Documents

• Letter: 2004-12-02
• Letter: 2006-09-15
• Letter: 2010-12-28
• Letter: 2012-08-31
• Label: 2004-12-03
• Label: 2006-09-15
• Label: 2010-12-26
• Label: 2012-08-31
• Review: 2007-01-23
• Letter: 2006-04-05
• Letter: 2008-10-22
• Letter: 2011-10-12
• Label: 2011-10-12
• Letter: 2020-01-14
• Label: 2020-01-14
• Letter: 2021-08-06

Application Sponsors

NDA 021527

BOEHRINGER INGELHEIM

Marketing Status

• Prescription: 001

Application Products

001

AEROSOL, METERED;INHALATION

0.021MG/INH

1

ATROVENT HFA

IPRATROPIUM BROMIDE

FDA Submissions

TYPE 3; Type 3 - New Dosage Form	ORIG	1	AP	2004-11-17	STANDARD
LABELING; Labeling	SUPPL	3	AP	2006-03-23	STANDARD
LABELING; Labeling	SUPPL	5	AP	2006-09-05	STANDARD
LABELING; Labeling	SUPPL	11	AP	2008-10-14	STANDARD
LABELING; Labeling	SUPPL	16	AP	2010-12-23	UNKNOWN
MANUF (CMC); Manufacturing (CMC)	SUPPL	19	AP	2011-10-06	N/A
LABELING; Labeling	SUPPL	21	AP	2012-08-30	UNKNOWN
MANUF (CMC); Manufacturing (CMC)	SUPPL	22	AP	2015-04-29	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	23	AP	2014-05-09	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	26	AP	2016-04-29	STANDARD
LABELING; Labeling	SUPPL	27	AP	2016-08-11	STANDARD
LABELING; Labeling	SUPPL	33	AP	2020-01-10	STANDARD

Submissions Property Types

SUPPL	16	Null	31
SUPPL	19	Null	7
SUPPL	21	Null	6
SUPPL	22	Null	0
SUPPL	23	Null	0
SUPPL	26	Null	0
SUPPL	27	Null	15
SUPPL	33	Null	15

CDER Filings

BOEHRINGER INGELHEIM

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 21527
            [companyName] => BOEHRINGER INGELHEIM
            [docInserts] => ["",""]
            [products] => [{"drugName":"ATROVENT HFA","activeIngredients":"IPRATROPIUM BROMIDE","strength":"0.021MG\/INH","dosageForm":"AEROSOL, METERED;INHALATION","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"Yes"}]
            [labels] => [{"actionDate":"01\/10\/2020","submission":"SUPPL-33","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/021527s033lbl.pdf\"}]","notes":""},{"actionDate":"08\/30\/2012","submission":"SUPPL-21","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2012\\\/021527s021lbl.pdf\"}]","notes":""},{"actionDate":"10\/06\/2011","submission":"SUPPL-19","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2011\\\/021527s019lbl.pdf\"}]","notes":""},{"actionDate":"12\/23\/2010","submission":"SUPPL-16","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2010\\\/021527s016lbl.pdf\"}]","notes":""},{"actionDate":"09\/05\/2006","submission":"SUPPL-5","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2006\\\/021527s005lbl.pdf\"}]","notes":""},{"actionDate":"11\/17\/2004","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2004\\\/21527lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"ATROVENT HFA","submission":"IPRATROPIUM BROMIDE","actionType":"0.021MG\/INH","submissionClassification":"AEROSOL, METERED;INHALATION","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"}]
            [supplements] => 
            [actionDate] => 2020-01-10
        )

)