PRINSTON INC FDA Approval ANDA 212668

ANDA 212668

PRINSTON INC

FDA Drug Application

Application #212668

Application Sponsors

ANDA 212668PRINSTON INC

Marketing Status

Prescription001
Prescription002

Application Products

001INJECTABLE;INJECTION50MG/5ML (10MG/ML)0ROCURONIUM BROMIDEROCURONIUM BROMIDE
002INJECTABLE;INJECTION100MG/10ML (10MG/ML)0ROCURONIUM BROMIDEROCURONIUM BROMIDE

FDA Submissions

UNKNOWN; ORIG1AP2022-05-26STANDARD

Submissions Property Types

ORIG1Null15

TE Codes

001PrescriptionAP
002PrescriptionAP

CDER Filings

PRINSTON INC
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 212668
            [companyName] => PRINSTON INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"ROCURONIUM BROMIDE","activeIngredients":"ROCURONIUM BROMIDE","strength":"50MG\/5ML (10MG\/ML)","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"ROCURONIUM BROMIDE","activeIngredients":"ROCURONIUM BROMIDE","strength":"100MG\/10ML (10MG\/ML)","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"05\/26\/2022","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2022-05-26
        )

)

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