HIKMA FDA Approval ANDA 203725

ANDA 203725

HIKMA

FDA Drug Application

Application #203725

Application Sponsors

ANDA 203725HIKMA

Marketing Status

Prescription001
Prescription002

Application Products

001INJECTABLE;INJECTION10MG/VIAL0VECURONIUM BROMIDEVECURONIUM BROMIDE
002INJECTABLE;INJECTION20MG/VIAL0VECURONIUM BROMIDEVECURONIUM BROMIDE

FDA Submissions

UNKNOWN; ORIG1AP2019-07-30

Submissions Property Types

ORIG1Null15

TE Codes

001PrescriptionAP
002PrescriptionAP

CDER Filings

HIKMA
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 203725
            [companyName] => HIKMA
            [docInserts] => ["",""]
            [products] => [{"drugName":"VECURONIUM BROMIDE","activeIngredients":"VECURONIUM BROMIDE","strength":"10MG\/VIAL","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"VECURONIUM BROMIDE","activeIngredients":"VECURONIUM BROMIDE","strength":"20MG\/VIAL","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"07\/30\/2019","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2019-07-30
        )

)

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.