NDA 215007

NEXAIR LLC

FDA Drug Application

Application #215007

Documents

• Letter: 2020-07-31

Application Sponsors

NDA 215007

NEXAIR LLC

Marketing Status

• Prescription: 001

Application Products

001

GAS;INHALATION

N/A

0

CARBON DIOXIDE, USP

CARBON DIOIDE

FDA Submissions

UNKNOWN;

ORIG

1

AP

2020-07-18

UNKNOWN

CDER Filings

NEXAIR LLC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 215007
            [companyName] => NEXAIR LLC
            [docInserts] => ["",""]
            [products] => [{"drugName":"CARBON DIOXIDE, USP","activeIngredients":"CARBON DIOIDE","strength":"N\/A","dosageForm":"GAS;INHALATION","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"07\/18\/2020","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"UNKNOWN","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2020\\\/215007Orig1s000MGltr.pdf\"}]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2020-07-18
        )

)