SANOFI AVENTIS US FDA Approval NDA 020750

NDA 020750

SANOFI AVENTIS US

FDA Drug Application

Application #020750

Documents

Review2010-03-03

Application Sponsors

NDA 020750SANOFI AVENTIS US

Marketing Status

Discontinued001

Application Products

001SOLUTION;INHALATION0.5%0TILADENEDOCROMIL SODIUM

FDA Submissions

TYPE 3; Type 3 - New Dosage FormORIG1AP1997-10-01STANDARD

Submissions Property Types

ORIG1Null0

CDER Filings

SANOFI AVENTIS US
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 20750
            [companyName] => SANOFI AVENTIS US
            [docInserts] => ["",""]
            [products] => [{"drugName":"TILADE","activeIngredients":"NEDOCROMIL SODIUM","strength":"0.5%","dosageForm":"SOLUTION;INHALATION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"TILADE","submission":"NEDOCROMIL SODIUM","actionType":"0.5%","submissionClassification":"SOLUTION;INHALATION","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)

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