EUGIA PHARMA FDA Approval ANDA 214569

ANDA 214569

EUGIA PHARMA

FDA Drug Application

Application #214569

Application Sponsors

ANDA 214569EUGIA PHARMA

Marketing Status

Prescription001

Application Products

001INJECTABLE;INTRAVENOUS50MG/VIAL0DECITABINEDECITABINE

FDA Submissions

UNKNOWN; ORIG1AP2021-09-20STANDARD

Submissions Property Types

ORIG1Null15

TE Codes

001PrescriptionAP

CDER Filings

EUGIA PHARMA
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 214569
            [companyName] => EUGIA PHARMA
            [docInserts] => ["",""]
            [products] => [{"drugName":"DECITABINE","activeIngredients":"DECITABINE","strength":"50MG\/VIAL","dosageForm":"INJECTABLE;INTRAVENOUS","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"09\/20\/2021","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2021-09-20
        )

)

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