ANDA 075835

BAUSCH AND LOMB INC

FDA Drug Application

Application #075835

Documents

• Letter: 2003-04-15

Application Sponsors

ANDA 075835

BAUSCH AND LOMB INC

Marketing Status

• Discontinued: 001

Application Products

001

SOLUTION;INHALATION

0.02%

0

IPRATROPIUM BROMIDE

IPRATROPIUM BROMIDE

FDA Submissions

	ORIG	1	AP	2001-10-15
MANUF (CMC); Manufacturing (CMC)	SUPPL	2	AP	2002-10-02

Submissions Property Types

SUPPL	1	Null	0
SUPPL	2	Null	0

CDER Filings

BAUSCH AND LOMB INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 75835
            [companyName] => BAUSCH AND LOMB INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"IPRATROPIUM BROMIDE","activeIngredients":"IPRATROPIUM BROMIDE","strength":"0.02%","dosageForm":"SOLUTION;INHALATION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"IPRATROPIUM BROMIDE","submission":"IPRATROPIUM BROMIDE","actionType":"0.02%","submissionClassification":"SOLUTION;INHALATION","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)