NDA 211781

A-OX WELDING SUPPLY CO, INC.

FDA Drug Application

Application #211781

Documents

• Letter: 2018-08-27

Application Sponsors

NDA 211781

A-OX WELDING SUPPLY CO, INC.

Marketing Status

• Prescription: 001

Application Products

001

GAS;INHALATION

N/A

0

HELIUM, USP

HELIUM

FDA Submissions

MEDGAS; Medical Gas

ORIG

1

AP

2018-04-23

UNKNOWN

CDER Filings

A-OX WELDING SUPPLY CO, INC.

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 211781
            [companyName] => A-OX WELDING SUPPLY CO, INC.
            [docInserts] => ["",""]
            [products] => [{"drugName":"HELIUM, USP","activeIngredients":"HELIUM","strength":"N\/A","dosageForm":"GAS;INHALATION","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"04\/23\/2018","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"UNKNOWN","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2018\\\/NDA211781-NADA141500-DeemedGranted.pdf\"}]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2018-04-23
        )

)