ABSOLUTE AIR, LLC FDA Approval NDA 217500

NDA 217500

ABSOLUTE AIR, LLC

FDA Drug Application

Application #217500

Documents

Letter2022-07-07

Application Sponsors

NDA 217500ABSOLUTE AIR, LLC

Marketing Status

Prescription001

Application Products

001GAS;INHALATIONN/A0Nitrogen, NFNitrogen

FDA Submissions

UNKNOWN; ORIG1AP2022-06-10UNKNOWN

CDER Filings

ABSOLUTE AIR, LLC
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 217500
            [companyName] => ABSOLUTE AIR, LLC
            [docInserts] => ["",""]
            [products] => [{"drugName":"Nitrogen, NF","activeIngredients":"Nitrogen","strength":"N\/A","dosageForm":"GAS;INHALATION","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"06\/10\/2022","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"UNKNOWN","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2022\\\/217500Orig1s000MGLtr.pdf\"}]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2022-06-10
        )

)

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