EUGIA PHARMA FDA Approval ANDA 210604

ANDA 210604

EUGIA PHARMA

FDA Drug Application

Application #210604

Application Sponsors

ANDA 210604EUGIA PHARMA

Marketing Status

Prescription001
Prescription002

Application Products

001TABLET;ORAL150MG0CAPECITABINECAPECITABINE
002TABLET;ORAL500MG0CAPECITABINECAPECITABINE

FDA Submissions

UNKNOWN; ORIG1AP2018-04-17STANDARD

Submissions Property Types

ORIG1Null15

TE Codes

001PrescriptionAB
002PrescriptionAB

CDER Filings

EUGIA PHARMA
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 210604
            [companyName] => EUGIA PHARMA
            [docInserts] => ["",""]
            [products] => [{"drugName":"CAPECITABINE","activeIngredients":"CAPECITABINE","strength":"150MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"CAPECITABINE","activeIngredients":"CAPECITABINE","strength":"500MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"04\/17\/2018","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2018-04-17
        )

)

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.