METHODIST FDA Approval ANDA 215083

ANDA 215083

METHODIST

FDA Drug Application

Application #215083

Application Sponsors

ANDA 215083METHODIST

Marketing Status

Prescription001

Application Products

001INJECTABLE;INTRAVENOUS3.75mCi-260mCi/ML0AMMONIA N 13AMMONIA N-13

FDA Submissions

UNKNOWN; ORIG1AP2021-07-09STANDARD

Submissions Property Types

ORIG1Null7

TE Codes

001PrescriptionAP

CDER Filings

METHODIST
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 215083
            [companyName] => METHODIST
            [docInserts] => ["",""]
            [products] => [{"drugName":"AMMONIA N 13","activeIngredients":"AMMONIA N-13","strength":"3.75mCi-260mCi\/ML","dosageForm":"INJECTABLE;INTRAVENOUS","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"07\/09\/2021","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2021-07-09
        )

)

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