ANDA 209528

QILU PHARM CO LTD

FDA Drug Application

Application #209528

Application Sponsors

ANDA 209528

QILU PHARM CO LTD

Marketing Status

• None (Tentative Approval): 001

Application Products

001

POWDER;INTRAVENOUS

60MG/VIAL

0

CARFILZOMIB

CARFILZOMIB

FDA Submissions

UNKNOWN;

ORIG

1

TA

2019-01-18

STANDARD

Submissions Property Types

ORIG

1

Null

31

CDER Filings

QILU PHARM CO LTD

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 209528
            [companyName] => QILU PHARM CO LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"CARFILZOMIB","activeIngredients":"CARFILZOMIB","strength":"60MG\/VIAL","dosageForm":"POWDER;INTRAVENOUS","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"01\/18\/2019","submission":"ORIG-1","actionType":"Tentative Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2019-01-18
        )

)