NDA 020291

BOEHRINGER INGELHEIM

FDA Drug Application

Application #020291

Documents

• Letter: 2009-05-13
• Label: 2009-05-11
• Letter: 2006-06-02
• Letter: 2008-11-13
• Letter: 2009-06-08
• Letter: 2011-04-06
• Letter: 2012-09-20
• Letter: 2012-08-22
• Label: 2006-06-02
• Label: 2008-11-12
• Label: 2009-06-04
• Label: 2011-04-01
• Label: 2012-08-20

Application Sponsors

NDA 020291

BOEHRINGER INGELHEIM

Marketing Status

• Discontinued: 001

Application Products

001

AEROSOL, METERED;INHALATION

EQ 0.09MG BASE/INH;0.018MG/INH

0

COMBIVENT

ALBUTEROL SULFATE; IPRATROPIUM BROMIDE

FDA Submissions

TYPE 4; Type 4 - New Combination	ORIG	1	AP	1996-10-24	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	2	AP	1997-10-14	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	3	AP	1997-11-26	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	5	AP	1999-03-23	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	6	AP	1998-06-19	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	7	AP	1999-02-22	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	9	AP	1999-08-18	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	11	AP	1999-09-16	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	12	AP	2001-07-23	STANDARD
LABELING; Labeling	SUPPL	20	AP	2006-06-01	STANDARD
LABELING; Labeling	SUPPL	23	AP	2008-11-10	STANDARD
LABELING; Labeling	SUPPL	26	AP	2009-05-07	STANDARD
LABELING; Labeling	SUPPL	27	AP	2009-06-02	STANDARD
LABELING; Labeling	SUPPL	29	AP	2011-04-01	UNKNOWN
LABELING; Labeling	SUPPL	30	AP	2012-09-17	UNKNOWN
LABELING; Labeling	SUPPL	31	AP	2012-08-20	UNKNOWN

Submissions Property Types

SUPPL	1	Null	0
SUPPL	2	Null	0
SUPPL	3	Null	0
SUPPL	5	Null	0
SUPPL	6	Null	0
SUPPL	7	Null	0
SUPPL	9	Null	0
SUPPL	11	Null	0
SUPPL	12	Null	0
SUPPL	29	Null	6
SUPPL	30	Null	6
SUPPL	31	Null	6

CDER Filings

BOEHRINGER INGELHEIM

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 20291
            [companyName] => BOEHRINGER INGELHEIM
            [docInserts] => ["",""]
            [products] => [{"drugName":"COMBIVENT","activeIngredients":"ALBUTEROL SULFATE; IPRATROPIUM BROMIDE","strength":"EQ 0.09MG BASE\/INH;0.018MG\/INH","dosageForm":"AEROSOL, METERED;INHALATION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => [{"actionDate":"08\/20\/2012","submission":"SUPPL-31","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2012\\\/020291s031lbl.pdf\"}]","notes":""},{"actionDate":"04\/01\/2011","submission":"SUPPL-29","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2011\\\/020291s029lbl.pdf\"}]","notes":""},{"actionDate":"06\/02\/2009","submission":"SUPPL-27","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2009\\\/020291s027lbl.pdf\"}]","notes":""},{"actionDate":"05\/07\/2009","submission":"SUPPL-26","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2009\\\/020291s026lbl.pdf\"}]","notes":""},{"actionDate":"11\/10\/2008","submission":"SUPPL-23","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2008\\\/020291s023lbl.pdf\"}]","notes":""},{"actionDate":"06\/01\/2006","submission":"SUPPL-20","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2006\\\/020291s020lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"COMBIVENT","submission":"ALBUTEROL SULFATE; IPRATROPIUM BROMIDE","actionType":"EQ 0.09MG BASE\/INH;0.018MG\/INH","submissionClassification":"AEROSOL, METERED;INHALATION","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 2012-08-20
        )

)