Documents
Application Sponsors
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
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
)
)