CURIUM FDA Approval ANDA 071909

ANDA 071909

CURIUM

FDA Drug Application

Application #071909

Application Sponsors

ANDA 071909CURIUM

Marketing Status

Prescription001

Application Products

001CAPSULE;ORAL100uCi0SODIUM IODIDE I 123SODIUM IODIDE I-123

FDA Submissions

ORIG1AP1989-02-28
MANUF (CMC); Manufacturing (CMC)SUPPL2AP1991-03-18
MANUF (CMC); Manufacturing (CMC)SUPPL3AP1993-06-29

Submissions Property Types

SUPPL1Null0
SUPPL2Null0
SUPPL3Null0

TE Codes

001PrescriptionAA

CDER Filings

CURIUM
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 71909
            [companyName] => CURIUM
            [docInserts] => ["",""]
            [products] => [{"drugName":"SODIUM IODIDE I 123","activeIngredients":"SODIUM IODIDE I-123","strength":"100uCi","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"SODIUM IODIDE I 123","submission":"SODIUM IODIDE I-123","actionType":"100uCi","submissionClassification":"CAPSULE;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)

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