NDA 213609

ROBERTS OXYGEN CO INC

FDA Drug Application

Application #213609

Documents

• Letter: 2019-10-01

Application Sponsors

NDA 213609

ROBERTS OXYGEN CO INC

Marketing Status

• Prescription: 000

Application Products

000

GAS;INHALATION

N/A

0

HELIUM, USP

HELIUM

FDA Submissions

MEDGAS; Medical Gas

ORIG

1

AP

2019-07-14

UNKNOWN

CDER Filings

ROBERTS OXYGEN CO INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 213609
            [companyName] => ROBERTS OXYGEN CO INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"HELIUM, USP","activeIngredients":"HELIUM","strength":"N\/A","dosageForm":"GAS;INHALATION","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"07\/14\/2019","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"UNKNOWN","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2019\\\/213609MGLtr.pdf\"}]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2019-07-14
        )

)