NDA 019548

SANOFI AVENTIS US

FDA Drug Application

Application #019548

Application Sponsors

NDA 019548

SANOFI AVENTIS US

Marketing Status

• Discontinued: 001

Application Products

001

SOLUTION;INHALATION

0.2%

0

TORNALATE

BITOLTEROL MESYLATE

FDA Submissions

TYPE 3; Type 3 - New Dosage Form	ORIG	1	AP	1992-02-19	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	2	AP	1994-09-21	STANDARD
LABELING; Labeling	SUPPL	3	AP	2007-12-07	STANDARD
LABELING; Labeling	SUPPL	4	AP	2007-12-07	STANDARD

Submissions Property Types

SUPPL

2

Null

0

CDER Filings

SANOFI AVENTIS US

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 19548
            [companyName] => SANOFI AVENTIS US
            [docInserts] => ["",""]
            [products] => [{"drugName":"TORNALATE","activeIngredients":"BITOLTEROL MESYLATE","strength":"0.2%","dosageForm":"SOLUTION;INHALATION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"TORNALATE","submission":"BITOLTEROL MESYLATE","actionType":"0.2%","submissionClassification":"SOLUTION;INHALATION","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)