PRAXAIR DISTRIBUTION INC FDA Approval NDA 205909

NDA 205909

PRAXAIR DISTRIBUTION INC

FDA Drug Application

Application #205909

Documents

Letter2015-09-29

Application Sponsors

NDA 205909PRAXAIR DISTRIBUTION INC

Marketing Status

Prescription001

Application Products

001GAS;INHALATIONN/A0MEDICAL AIR, USPMEDICAL AIR

FDA Submissions

MEDGAS; Medical GasORIG1AP2013-08-05STANDARD

CDER Filings

PRAXAIR DISTRIBUTION INC
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 205909
            [companyName] => PRAXAIR DISTRIBUTION INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"MEDICAL AIR, USP","activeIngredients":"MEDICAL AIR","strength":"N\/A","dosageForm":"GAS;INHALATION","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"08\/05\/2013","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2013\\\/205909MGLtr.pdf\"}]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2013-08-05
        )

)

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