Documents
Application Sponsors
Marketing Status
Application Products
001 | TABLET;ORAL | 250MG | 0 | ABIRATERONE ACETATE | ABIRATERONE ACETATE |
FDA Submissions
UNKNOWN; | ORIG | 1 | AP | 2018-10-31 | STANDARD |
LABELING; Labeling | SUPPL | 2 | AP | 2021-07-02 | STANDARD |
Submissions Property Types
TE Codes
CDER Filings
HIKMA
cder:Array
(
[0] => Array
(
[ApplNo] => 208339
[companyName] => HIKMA
[docInserts] => ["",""]
[products] => [{"drugName":"ABIRATERONE ACETATE","activeIngredients":"ABIRATERONE ACETATE","strength":"250MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"10\/31\/2018","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2018\\\/208339Orig1s000ltr.pdf\"}]","notes":"> Label is not available on this site."}]
[supplements] =>
[actionDate] => 2018-10-31
)
)