NDA 213990

ILMO Products Company

FDA Drug Application

Application #213990

Documents

• Letter: 2020-04-16

Application Sponsors

NDA 213990

ILMO Products Company

Marketing Status

• Prescription: 001

Application Products

001

GAS;INHALATION

N/A

0

Helium, USP

FDA Submissions

MEDGAS; Medical Gas

ORIG

1

AP

2019-10-27

UNKNOWN

CDER Filings

ILMO Products Company

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 213990
            [companyName] => ILMO Products 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":"10\/27\/2019","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"UNKNOWN","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2020\\\/213990orig1s000MGltr.pdf\"}]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2019-10-27
        )

)