UNIV WISCONSIN FDA Approval ANDA 211740

ANDA 211740

UNIV WISCONSIN

FDA Drug Application

Application #211740

Application Sponsors

ANDA 211740UNIV WISCONSIN

Marketing Status

Prescription001

Application Products

001INJECTABLE;INTRAVENOUS30mCi-300mCi/8ML (3.75-37.5mCi/ML)0AMMONIA N 13AMMONIA N-13

FDA Submissions

UNKNOWN; ORIG1AP2020-09-09STANDARD

Submissions Property Types

ORIG1Null15

TE Codes

001PrescriptionAP

CDER Filings

UNIV WISCONSIN
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 211740
            [companyName] => UNIV WISCONSIN
            [docInserts] => ["",""]
            [products] => [{"drugName":"AMMONIA N 13","activeIngredients":"AMMONIA N-13","strength":"30mCi-300mCi\/8ML (3.75-37.5mCi\/ML)","dosageForm":"INJECTABLE;INTRAVENOUS","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"09\/09\/2020","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2020-09-09
        )

)

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