EUGIA PHARMA FDA Approval ANDA 213278

ANDA 213278

EUGIA PHARMA

FDA Drug Application

Application #213278

Application Sponsors

ANDA 213278EUGIA PHARMA

Marketing Status

Prescription001
Prescription002
Prescription003

Application Products

001INJECTABLE;INJECTION40MG/2ML (20MG/ML)0IRINOTECAN HYDROCHLORIDEIRINOTECAN HYDROCHLORIDE
002INJECTABLE;INJECTION100MG/5ML (20MG/ML)0IRINOTECAN HYDROCHLORIDEIRINOTECAN HYDROCHLORIDE
003INJECTABLE;INJECTION300MG/15ML (20MG/ML)0IRINOTECAN HYDROCHLORIDEIRINOTECAN HYDROCHLORIDE

FDA Submissions

UNKNOWN; ORIG1AP2020-11-03STANDARD

TE Codes

001PrescriptionAP
002PrescriptionAP
003PrescriptionAP

CDER Filings

EUGIA PHARMA
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 213278
            [companyName] => EUGIA PHARMA
            [docInserts] => ["",""]
            [products] => [{"drugName":"IRINOTECAN HYDROCHLORIDE","activeIngredients":"IRINOTECAN HYDROCHLORIDE","strength":"40MG\/2ML (20MG\/ML)","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"IRINOTECAN HYDROCHLORIDE","activeIngredients":"IRINOTECAN HYDROCHLORIDE","strength":"100MG\/5ML (20MG\/ML)","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"IRINOTECAN HYDROCHLORIDE","activeIngredients":"IRINOTECAN HYDROCHLORIDE","strength":"300MG\/15ML (20MG\/ML)","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"11\/02\/2020","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2020-11-02
        )

)

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