UNIV SOUTHERN CA FDA Approval ANDA 209341

ANDA 209341

UNIV SOUTHERN CA

FDA Drug Application

Application #209341

Application Sponsors

ANDA 209341UNIV SOUTHERN CA

Marketing Status

Prescription001

Application Products

001INJECTABLE;INTRAVENOUS20-300mCi/ML0FLUDEOXYGLUCOSE F18FLUDEOXYGLUCOSE F-18

FDA Submissions

UNKNOWN; ORIG1AP2020-12-16STANDARD

Submissions Property Types

ORIG1Null7

TE Codes

001PrescriptionAP

CDER Filings

UNIV SOUTHERN CA
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 209341
            [companyName] => UNIV SOUTHERN CA
            [docInserts] => ["",""]
            [products] => [{"drugName":"FLUDEOXYGLUCOSE F18","activeIngredients":"FLUDEOXYGLUCOSE F-18","strength":"20-300mCi\/ML","dosageForm":"INJECTABLE;INTRAVENOUS","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"12\/16\/2020","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2020-12-16
        )

)

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