CURIUM FDA Approval ANDA 213792

ANDA 213792

CURIUM

FDA Drug Application

Application #213792

Application Sponsors

ANDA 213792CURIUM

Marketing Status

Prescription001

Application Products

001SOLUTION;INTRAVENOUS5mCi/2.5ML (2mCi/ML)0IOFLUPANE I-123IOFLUPANE I-123

FDA Submissions

UNKNOWN; ORIG1AP2022-03-30STANDARD

Submissions Property Types

ORIG1Null15

TE Codes

001PrescriptionAP

CDER Filings

CURIUM
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 213792
            [companyName] => CURIUM
            [docInserts] => ["",""]
            [products] => [{"drugName":"IOFLUPANE I-123","activeIngredients":"IOFLUPANE I-123","strength":"5mCi\/2.5ML (2mCi\/ML)","dosageForm":"SOLUTION;INTRAVENOUS","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"03\/30\/2022","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2022-03-30
        )

)

© 2022 FDA.report
This site is not affiliated with or endorsed by the FDA.