NDA 207970

ACTAVIS LLC

FDA Drug Application

Application #207970

Documents

• Letter: 2015-08-21

Application Sponsors

NDA 207970

ACTAVIS LLC

Marketing Status

• None (Tentative Approval): 001
• None (Tentative Approval): 002

Application Products

001	INJECTABLE;INJECTION	40MG/4ML	0	CABAZITAXEL INJECTION	CABAZITAXEL
002	INJECTABLE;INJECTION	60MG/6ML	0	CABAZITAXEL INJECTION	CABAZITAXEL

FDA Submissions

TYPE 5; Type 5 - New Formulation or New Manufacturer

ORIG

1

TA

2018-01-17

STANDARD

Submissions Property Types

ORIG

1

Null

31

CDER Filings

ACTAVIS LLC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 207970
            [companyName] => ACTAVIS LLC
            [docInserts] => ["",""]
            [products] => [{"drugName":"CABAZITAXEL INJECTION","activeIngredients":"CABAZITAXEL","strength":"40MG\/4ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"},{"drugName":"CABAZITAXEL INJECTION","activeIngredients":"CABAZITAXEL","strength":"60MG\/6ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"01\/17\/2018","submission":"ORIG-1","actionType":"Tentative Approval","submissionClassification":"Type 5 - New Formulation or New Manufacturer","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2015\\\/207970Orig1s000TAltr.pdf\"}]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2018-01-17
        )

)