Application Sponsors
ANDA 210726 | TEVA PHARMS USA | |
Marketing Status
Application Products
001 | TABLET;ORAL | 500MG | 0 | ABIRATERONE ACETATE | ABIRATERONE ACETATE |
FDA Submissions
UNKNOWN; | ORIG | 1 | AP | 2023-01-26 | STANDARD |
Submissions Property Types
TE Codes
CDER Filings
TEVA PHARMS USA
cder:Array
(
[0] => Array
(
[ApplNo] => 210726
[companyName] => TEVA PHARMS USA
[docInserts] => ["",""]
[products] => [{"drugName":"ABIRATERONE ACETATE","activeIngredients":"ABIRATERONE ACETATE","strength":"500MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"01\/26\/2023","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
[supplements] =>
[actionDate] => 2023-01-26
)
)