ANDA 209659

FRESENIUS KABI USA

FDA Drug Application

Application #209659

Application Sponsors

ANDA 209659

FRESENIUS KABI USA

Marketing Status

• None (Tentative Approval): 001

Application Products

001

INJECTABLE;INTRAVENOUS, SUBCUTANEOUS

3.5MG/VIAL

0

BORTEZOMIB

BORTEZOMIB

FDA Submissions

UNKNOWN;

ORIG

1

TA

2020-03-09

STANDARD

Submissions Property Types

ORIG

1

Null

31

TE Codes

001

Prescription

AP

CDER Filings

FRESENIUS KABI USA

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 209659
            [companyName] => FRESENIUS KABI USA
            [docInserts] => ["",""]
            [products] => [{"drugName":"BORTEZOMIB","activeIngredients":"BORTEZOMIB","strength":"UNKNOWN","dosageForm":"UNKNOWN","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"03\/09\/2020","submission":"ORIG-1","actionType":"Tentative Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2020-03-09
        )

)