NDA 216307

GENERAL AIR SERVICE & SUPPLY COMPANY

FDA Drug Application

Application #216307

Documents

• Letter: 2021-12-08

Application Sponsors

NDA 216307

GENERAL AIR SERVICE & SUPPLY COMPANY

Marketing Status

• Prescription: 001

Application Products

001

GAS;INHALATION

N/A

0

HELIUM, USP

HELIUM

FDA Submissions

MEDGAS; Medical Gas

ORIG

1

TA

2021-05-27

UNKNOWN

CDER Filings

GENERAL AIR SERVICE & SUPPLY COMPANY

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 216307
            [companyName] => GENERAL AIR SERVICE & SUPPLY COMPANY
            [docInserts] => ["",""]
            [products] => [{"drugName":"HELIUM, USP","activeIngredients":"HELIUM","strength":"N\/A","dosageForm":"GAS;INHALATION","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"05\/27\/2021","submission":"ORIG-1","actionType":"Tentative Approval","submissionClassification":"","reviewPriority":"UNKNOWN","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2021\\\/216307Orig1s000MGLtr.pdf\"}]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2021-05-27
        )

)