NDA 210235

PRAXAIR DISTRIBUTION INC

FDA Drug Application

Application #210235

Documents

• Letter: 2018-03-18

Application Sponsors

NDA 210235

PRAXAIR DISTRIBUTION INC

Marketing Status

• Prescription: 001

Application Products

001

GAS;INHALATION

N/A

0

NITROUS OXIDE, USP

NITROUS OXIDE

FDA Submissions

MEDGAS; Medical Gas

ORIG

1

AP

2017-03-06

UNKNOWN

CDER Filings

PRAXAIR DISTRIBUTION INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 210235
            [companyName] => PRAXAIR DISTRIBUTION INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"NITROUS OXIDE, USP","activeIngredients":"NITROUS OXIDE","strength":"N\/A","dosageForm":"GAS;INHALATION","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"03\/06\/2017","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"UNKNOWN","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2017\\\/NDA210235-NADA141479-DeemedGranted-signed.pdf\"}]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2017-03-06
        )

)