NDA 205819

NORCO INC

FDA Drug Application

Application #205819

Documents

• Letter: 2015-10-06

Application Sponsors

NDA 205819

NORCO INC

Marketing Status

• Prescription: 001

Application Products

001

GAS;INHALATION

N/A

0

HELIUM, USP

HELIUM

FDA Submissions

MEDGAS; Medical Gas

ORIG

1

AP

2013-07-14

STANDARD

CDER Filings

NORCO INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 205819
            [companyName] => NORCO 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\/2013","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2013\\\/205819MGltr.pdf\"}]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2013-07-14
        )

)