Documents
Application Sponsors
Marketing Status
None (Tentative Approval) | 001 |
Application Products
001 | SOLUTION;IV (INFUSION) | 60MG/1.5ML (40MG/ML) | 0 | CABAZITAXEL | CABAZITAXEL |
FDA Submissions
UNKNOWN; | ORIG | 1 | TA | 2018-07-11 | STANDARD |
Submissions Property Types
CDER Filings
APOTEX INC
cder:Array
(
[0] => Array
(
[ApplNo] => 207736
[companyName] => APOTEX INC
[docInserts] => ["",""]
[products] => [{"drugName":"CABAZITAXEL","activeIngredients":"CABAZITAXEL","strength":"60MG\/1.5ML (40MG\/ML)","dosageForm":"SOLUTION;IV (INFUSION)","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"07\/11\/2018","submission":"ORIG-1","actionType":"Tentative Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2018\\\/207736Orig1s000TAltr.pdf\"}]","notes":"> Label is not available on this site."}]
[supplements] =>
[actionDate] => 2018-07-11
)
)