HIKMA FDA Approval ANDA 204490

ANDA 204490

HIKMA

FDA Drug Application

Application #204490

Application Sponsors

ANDA 204490HIKMA

Marketing Status

Prescription001
Prescription002

Application Products

001INJECTABLE;INJECTION20MG/ML (20MG/ML)0DOCETAXELDOCETAXEL
002INJECTABLE;INJECTION80MG/4ML (20MG/ML)0DOCETAXELDOCETAXEL

FDA Submissions

UNKNOWN; ORIG1AP2021-01-14STANDARD

Submissions Property Types

ORIG1Null15

TE Codes

001PrescriptionAP
002PrescriptionAP

CDER Filings

HIKMA
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 204490
            [companyName] => HIKMA
            [docInserts] => ["",""]
            [products] => [{"drugName":"DOCETAXEL","activeIngredients":"DOCETAXEL","strength":"20MG\/ML (20MG\/ML)","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"DOCETAXEL","activeIngredients":"DOCETAXEL","strength":"80MG\/4ML (20MG\/ML)","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"01\/14\/2021","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2021-01-14
        )

)

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