AIRGAS USA LLC FDA Approval NDA 206025

NDA 206025

AIRGAS USA LLC

FDA Drug Application

Application #206025

Documents

Letter2015-09-30

Application Sponsors

NDA 206025AIRGAS USA LLC

Marketing Status

Prescription001

Application Products

001GAS;INHALATIONN/A0CARBON DIOXIDE, USPCARBON DIOXIDE

FDA Submissions

MEDGAS; Medical GasORIG1AP2013-09-07STANDARD

CDER Filings

AIRGAS USA LLC
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 206025
            [companyName] => AIRGAS USA LLC
            [docInserts] => ["",""]
            [products] => [{"drugName":"CARBON DIOXIDE, USP","activeIngredients":"CARBON DIOXIDE","strength":"N\/A","dosageForm":"GAS;INHALATION","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"09\/07\/2013","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2013\\\/206025MGLtr.pdf\"}]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2013-09-07
        )

)

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