NDA 020228

BOEHRINGER INGELHEIM

FDA Drug Application

Application #020228

Documents

• Review: 2008-04-02

Application Sponsors

NDA 020228

BOEHRINGER INGELHEIM

Marketing Status

• Discontinued: 001

Application Products

001

SOLUTION;INHALATION

0.02% **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**

1

ATROVENT

IPRATROPIUM BROMIDE

FDA Submissions

TYPE 3; Type 3 - New Dosage Form	ORIG	1	AP	1993-09-29	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	3	AP	1998-07-16	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	4	AP	1998-08-07	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	5	AP	1999-08-18	PRIORITY

Submissions Property Types

SUPPL	3	Null	0
SUPPL	4	Null	0
SUPPL	5	Null	0

CDER Filings

BOEHRINGER INGELHEIM

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 20228
            [companyName] => BOEHRINGER INGELHEIM
            [docInserts] => ["",""]
            [products] => [{"drugName":"ATROVENT","activeIngredients":"IPRATROPIUM BROMIDE","strength":"0.02% **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**","dosageForm":"SOLUTION;INHALATION","marketingStatus":"Discontinued","te":"None","rld":"Yes","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"ATROVENT","submission":"IPRATROPIUM BROMIDE","actionType":"0.02% **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**","submissionClassification":"SOLUTION;INHALATION","reviewPriority":"Discontinued","inserts":"[]","notes":">Yes"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)