ANDA 210823

EUGIA PHARMA

FDA Drug Application

Application #210823

Documents

• Letter: 2022-12-20

Application Sponsors

ANDA 210823

EUGIA PHARMA

Marketing Status

• Prescription: 001

Application Products

001

UNKNOWN

UNKNOWN

0

CARFILZOMIB

CARFILZOMIB

FDA Submissions

UNKNOWN;

ORIG

1

TA

2020-03-31

STANDARD

Submissions Property Types

ORIG

1

Null

31

CDER Filings

EUGIA PHARMA

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 210823
            [companyName] => EUGIA PHARMA
            [docInserts] => ["",""]
            [products] => [{"drugName":"CARFILZOMIB","activeIngredients":"CARFILZOMIB","strength":"UNKNOWN","dosageForm":"UNKNOWN","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"03\/31\/2020","submission":"ORIG-1","actionType":"Tentative Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2020-03-31
        )

)