NDA 020393

BOEHRINGER INGELHEIM

FDA Drug Application

Application #020393

Documents

• Letter: 1998-04-01
• Letter: 2003-05-30
• Letter: 2007-12-03
• Letter: 2011-02-07
• Label: 2003-06-08
• Label: 2007-12-03

Application Sponsors

NDA 020393

BOEHRINGER INGELHEIM

Marketing Status

• Discontinued: 001

Application Products

001

SPRAY, METERED;NASAL

0.021MG/SPRAY

1

ATROVENT

IPRATROPIUM BROMIDE

FDA Submissions

TYPE 3; Type 3 - New Dosage Form	ORIG	1	AP	1995-10-20	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	2	AP	2000-01-27	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	3	AP	1999-08-18	STANDARD
LABELING; Labeling	SUPPL	4	AP	2003-05-23	STANDARD
LABELING; Labeling	SUPPL	7	AP	2007-12-04	STANDARD
LABELING; Labeling	SUPPL	11	AP	2011-02-02	UNKNOWN
MANUF (CMC); Manufacturing (CMC)	SUPPL	13	AP	2015-01-05	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	14	AP	2015-05-11	STANDARD

Submissions Property Types

SUPPL	2	Null	0
SUPPL	3	Null	0
SUPPL	11	Null	31
SUPPL	13	Null	0
SUPPL	14	Null	0

CDER Filings

BOEHRINGER INGELHEIM

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 20393
            [companyName] => BOEHRINGER INGELHEIM
            [docInserts] => ["",""]
            [products] => [{"drugName":"ATROVENT","activeIngredients":"IPRATROPIUM BROMIDE","strength":"0.021MG\/SPRAY","dosageForm":"SPRAY, METERED;NASAL","marketingStatus":"Discontinued","te":"None","rld":"Yes","rs":"No"}]
            [labels] => [{"actionDate":"12\/04\/2007","submission":"SUPPL-7","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2007\\\/020393s007,020394s008lbl.pdf\"}]","notes":""},{"actionDate":"05\/23\/2003","submission":"SUPPL-4","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2003\\\/20393slr004,20394slr005_atrovent_lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"ATROVENT","submission":"IPRATROPIUM BROMIDE","actionType":"0.021MG\/SPRAY","submissionClassification":"SPRAY, METERED;NASAL","reviewPriority":"Discontinued","inserts":"[]","notes":">Yes"}]
            [supplements] => 
            [actionDate] => 2007-12-04
        )

)