PRINSTON INC FDA Approval ANDA 209474

ANDA 209474

PRINSTON INC

FDA Drug Application

Application #209474

Application Sponsors

ANDA 209474PRINSTON INC

Marketing Status

Prescription001

Application Products

001INJECTABLE;INTRAVENOUS500MG/5ML (100MG/ML)0LEVETIRACETAMLEVETIRACETAM

FDA Submissions

UNKNOWN; ORIG1AP2022-03-28STANDARD

Submissions Property Types

ORIG1Null7

TE Codes

001PrescriptionAP

CDER Filings

PRINSTON INC
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 209474
            [companyName] => PRINSTON INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"LEVETIRACETAM","activeIngredients":"LEVETIRACETAM","strength":"500MG\/5ML (100MG\/ML)","dosageForm":"INJECTABLE;INTRAVENOUS","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"03\/28\/2022","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2022-03-28
        )

)

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