NDA 216614

MIDDLESEX GASES TECHNOLOGIES, INC.

FDA Drug Application

Application #216614

Documents

• Letter: 2022-01-13

Application Sponsors

NDA 216614

MIDDLESEX GASES TECHNOLOGIES, INC.

Marketing Status

• Prescription: 001

Application Products

001

GAS;INHALATION

N/A

0

CARBON DIOXIDE, USP

CARBON DIOXIDE

FDA Submissions

UNKNOWN;

ORIG

1

AP

2021-10-18

UNKNOWN

CDER Filings

MIDDLESEX GASES TECHNOLOGIES, INC.

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 216614
            [companyName] => MIDDLESEX GASES TECHNOLOGIES, 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":"10\/18\/2021","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"UNKNOWN","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"httpS:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2022\\\/216614Orig1s000MGltr.pdf\"}]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2021-10-18
        )

)