NDA 021747

BOEHRINGER INGELHEIM

FDA Drug Application

Application #021747

Documents

• Letter: 2016-02-01
• Letter: 2016-06-10
• Label: 2011-10-12
• Label: 2014-10-21
• Label: 2016-02-25
• Label: 2016-06-13
• Summary Review: 2012-08-16
• Letter: 2011-10-12
• Letter: 2012-08-31
• Letter: 2014-10-22
• Label: 2012-08-31
• Review: 2012-08-16
• Letter: 2020-09-29
• Label: 2020-09-29

Application Sponsors

NDA 021747

BOEHRINGER INGELHEIM

Marketing Status

• Prescription: 001

Application Products

001

SPRAY, METERED;INHALATION

EQ 0.1MG BASE/INH;0.02MG/INH

1

COMBIVENT RESPIMAT

ALBUTEROL SULFATE; IPRATROPIUM BROMIDE

FDA Submissions

TYPE 3; Type 3 - New Dosage Form	ORIG	1	AP	2011-10-07	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	2	AP	2013-01-09	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	3	AP	2014-08-14	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	4	AP	2014-06-19	STANDARD
LABELING; Labeling	SUPPL	5	AP	2014-10-17	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	7	AP	2015-03-09	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	8	AP	2015-07-09	STANDARD
LABELING; Labeling	SUPPL	10	AP	2016-01-29	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	11	AP	2016-04-15	STANDARD
LABELING; Labeling	SUPPL	13	AP	2016-06-09	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	14	AP	2016-06-17	STANDARD
LABELING; Labeling	SUPPL	20	AP	2020-09-27	STANDARD

Submissions Property Types

ORIG	1	Null	7
SUPPL	2	Null	0
SUPPL	3	Null	0
SUPPL	4	Null	0
SUPPL	5	Null	15
SUPPL	7	Null	0
SUPPL	8	Null	0
SUPPL	10	Null	7
SUPPL	11	Null	0
SUPPL	13	Null	7
SUPPL	14	Null	0
SUPPL	20	Null	7

CDER Filings

BOEHRINGER INGELHEIM

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 21747
            [companyName] => BOEHRINGER INGELHEIM
            [docInserts] => ["",""]
            [products] => [{"drugName":"COMBIVENT RESPIMAT","activeIngredients":"ALBUTEROL SULFATE; IPRATROPIUM BROMIDE","strength":"EQ 0.1MG BASE\/INH;0.02MG\/INH","dosageForm":"SPRAY, METERED;INHALATION","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"Yes"}]
            [labels] => [{"actionDate":"09\/27\/2020","submission":"SUPPL-20","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/021747s020lbl.pdf\"}]","notes":""},{"actionDate":"06\/09\/2016","submission":"SUPPL-13","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/021747s013lbl.pdf\"}]","notes":""},{"actionDate":"01\/29\/2016","submission":"SUPPL-10","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/021747s010lbl.pdf\"}]","notes":""},{"actionDate":"10\/17\/2014","submission":"SUPPL-5","supplementCategories":"Labeling-Container\/Carton Labels","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/021747s005lbl.pdf\"}]","notes":""},{"actionDate":"10\/17\/2014","submission":"SUPPL-5","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/021747s005lbl.pdf\"}]","notes":""},{"actionDate":"08\/29\/2012","submission":"SUPPL-1","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2012\\\/021747s001lbl.pdf\"}]","notes":""},{"actionDate":"10\/07\/2011","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2011\\\/021747s000lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"COMBIVENT RESPIMAT","submission":"ALBUTEROL SULFATE; IPRATROPIUM BROMIDE","actionType":"EQ 0.1MG BASE\/INH;0.02MG\/INH","submissionClassification":"SPRAY, METERED;INHALATION","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"}]
            [supplements] => 
            [actionDate] => 2020-09-27
        )

)