NDA 020394

BOEHRINGER INGELHEIM

FDA Drug Application

Application #020394

Documents

• Letter: 1998-11-09
• Letter: 2011-02-24
• Other: 2011-12-16
• Letter: 2003-05-30
• Letter: 2008-10-21
• Label: 2004-09-20
• Review: 1998-11-09
• Review: 2000-10-27

Application Sponsors

NDA 020394

BOEHRINGER INGELHEIM

Marketing Status

• Discontinued: 001

Application Products

001

SPRAY, METERED;NASAL

0.042MG/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
EFFICACY; Efficacy	SUPPL	4	AP	2000-10-27	UNKNOWN
LABELING; Labeling	SUPPL	5	AP	2003-05-23	STANDARD
LABELING; Labeling	SUPPL	8	AP	2008-10-14	STANDARD
LABELING; Labeling	SUPPL	12	AP	2011-02-18	UNKNOWN

Submissions Property Types

SUPPL	2	Null	0
SUPPL	3	Null	0
SUPPL	12	Null	7

CDER Filings

BOEHRINGER INGELHEIM

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 20394
            [companyName] => BOEHRINGER INGELHEIM
            [docInserts] => ["",""]
            [products] => [{"drugName":"ATROVENT","activeIngredients":"IPRATROPIUM BROMIDE","strength":"0.042MG\/SPRAY","dosageForm":"SPRAY, METERED;NASAL","marketingStatus":"Discontinued","te":"None","rld":"Yes","rs":"No"}]
            [labels] => [{"actionDate":"05\/23\/2003","submission":"SUPPL-5","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2003\\\/020394s005lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"ATROVENT","submission":"IPRATROPIUM BROMIDE","actionType":"0.042MG\/SPRAY","submissionClassification":"SPRAY, METERED;NASAL","reviewPriority":"Discontinued","inserts":"[]","notes":">Yes"}]
            [supplements] => 
            [actionDate] => 2003-05-23
        )

)