A-OX WELDING SUPPLY CO, INC. FDA Approval NDA 213507

NDA 213507

A-OX WELDING SUPPLY CO, INC.

FDA Drug Application

Application #213507

Documents

Letter2019-08-29

Application Sponsors

NDA 213507A-OX WELDING SUPPLY CO, INC.

Marketing Status

Prescription001

Application Products

001GAS;INHALATIONN/A0CARBON DIOXIDE, USPCARBON DIOXIDE

FDA Submissions

MEDGAS; Medical GasORIG1AP2019-06-15

CDER Filings

A-OX WELDING SUPPLY CO, INC.
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 213507
            [companyName] => A-OX WELDING SUPPLY CO, INC.
            [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":"06\/15\/2019","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2019\\\/213507MGLtr.pdf\"}]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2019-06-15
        )

)

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