EUGIA PHARMA FDA Approval ANDA 216437

ANDA 216437

EUGIA PHARMA

FDA Drug Application

Application #216437

Application Sponsors

ANDA 216437EUGIA PHARMA

Marketing Status

Prescription001

Application Products

001SOLUTION;INTRAVENOUS0.4MG/5ML (0.08MG/ML)0REGADENOSONREGADENOSON

FDA Submissions

UNKNOWN; ORIG1AP2022-10-26STANDARD

Submissions Property Types

ORIG1Null15

TE Codes

001PrescriptionAP

CDER Filings

EUGIA PHARMA
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 216437
            [companyName] => EUGIA PHARMA
            [docInserts] => ["",""]
            [products] => [{"drugName":"REGADENOSON","activeIngredients":"REGADENOSON","strength":"0.4MG\/5ML (0.08MG\/ML)","dosageForm":"SOLUTION;INTRAVENOUS","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"10\/26\/2022","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2022-10-26
        )

)

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