HIKMA FDA Approval ANDA 213229

ANDA 213229

HIKMA

FDA Drug Application

Application #213229

Application Sponsors

ANDA 213229HIKMA

Marketing Status

Prescription001

Application Products

001INJECTABLE;INJECTION20MG/ML0SUCCINYLCHOLINE CHLORIDESUCCINYLCHOLINE CHLORIDE

FDA Submissions

UNKNOWN; ORIG1AP2020-06-12STANDARD

Submissions Property Types

ORIG1Null7

TE Codes

001PrescriptionAP

CDER Filings

HIKMA
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 213229
            [companyName] => HIKMA
            [docInserts] => ["",""]
            [products] => [{"drugName":"SUCCINYLCHOLINE CHLORIDE","activeIngredients":"SUCCINYLCHOLINE CHLORIDE","strength":"20MG\/ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"06\/12\/2020","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2020-06-12
        )

)

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