NDA 207937

FRESENIUS KABI USA

FDA Drug Application

Application #207937

Documents

• Letter: 2019-11-27

Application Sponsors

NDA 207937

FRESENIUS KABI USA

Marketing Status

• None (Tentative Approval): 001

Application Products

001

INJECTABLE;INJECTION

20MG/ML

0

CABAZITAXEL

CABAZITAXEL

FDA Submissions

TYPE 5; Type 5 - New Formulation or New Manufacturer

ORIG

1

TA

2019-11-22

STANDARD

Submissions Property Types

ORIG

1

Null

6

CDER Filings

FRESENIUS KABI USA

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 207937
            [companyName] => FRESENIUS KABI USA
            [docInserts] => ["",""]
            [products] => [{"drugName":"CABAZITAXEL","activeIngredients":"CABAZITAXEL","strength":"20MG\/ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"11\/22\/2019","submission":"ORIG-1","actionType":"Tentative Approval","submissionClassification":"Type 5 - New Formulation or New Manufacturer","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => [{"actionDate":"11\/22\/2019","submission":"SUPPL-1","supplementCategories":"","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2019\\\/207937Orig1s000TAltr.pdf\"}]","notes":"> Label is not available on this site."}]
            [actionDate] => 2019-11-22
        )

)