SANOFI AVENTIS US FDA Approval NDA 018000

NDA 018000

SANOFI AVENTIS US

FDA Drug Application

Application #018000

Application Sponsors

NDA 018000SANOFI AVENTIS US

Marketing Status

Discontinued001

Application Products

001AEROSOL, METERED;INHALATION0.2MG/INH0BRICANYLTERBUTALINE SULFATE

FDA Submissions

TYPE 3; Type 3 - New Dosage FormORIG1AP1985-03-19STANDARD

CDER Filings

SANOFI AVENTIS US
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 18000
            [companyName] => SANOFI AVENTIS US
            [docInserts] => ["",""]
            [products] => [{"drugName":"BRICANYL","activeIngredients":"TERBUTALINE SULFATE","strength":"0.2MG\/INH","dosageForm":"AEROSOL, METERED;INHALATION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"BRICANYL","submission":"TERBUTALINE SULFATE","actionType":"0.2MG\/INH","submissionClassification":"AEROSOL, METERED;INHALATION","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)

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