ANDA 209425

APOTEX

FDA Drug Application

Application #209425

Documents

• Letter: 2019-02-21

Application Sponsors

ANDA 209425

APOTEX

Marketing Status

• Prescription: 001

Application Products

001

POWDER;INTRAVENOUS

60MG/VIAL

0

CARFILZOMIB

CARFILZOMIB

FDA Submissions

UNKNOWN;

ORIG

1

AP

2020-03-16

STANDARD

Submissions Property Types

ORIG

1

Null

15

TE Codes

001

Prescription

AP

CDER Filings

APOTEX

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 209425
            [companyName] => APOTEX
            [docInserts] => ["",""]
            [products] => [{"drugName":"CARFILZOMIB","activeIngredients":"CARFILZOMIB","strength":"60MG\/VIAL","dosageForm":"POWDER;INTRAVENOUS","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"03\/16\/2020","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2019\\\/209425Orig1s000TAltr.pdf\"}]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2020-03-16
        )

)