APOTEX FDA Approval ANDA 205539

ANDA 205539

APOTEX

FDA Drug Application

Application #205539

Application Sponsors

ANDA 205539APOTEX

Marketing Status

Prescription001

Application Products

001INJECTABLE;INTRAVENOUS50MG/VIAL0DECITABINEDECITABINE

FDA Submissions

UNKNOWN; ORIG1AP2020-11-23STANDARD

Submissions Property Types

ORIG1Null15

TE Codes

001PrescriptionAP

CDER Filings

APOTEX
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 205539
            [companyName] => APOTEX
            [docInserts] => ["",""]
            [products] => [{"drugName":"DECITABINE","activeIngredients":"DECITABINE","strength":"50MG\/VIAL","dosageForm":"INJECTABLE;INTRAVENOUS","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"11\/23\/2020","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2020-11-23
        )

)

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