Documents
Application Sponsors
Marketing Status
| Prescription | 001 |
| Prescription | 002 |
Application Products
| 001 | TABLET;ORAL | 250MG | 0 | ABIRATERONE ACETATE | ABIRATERONE ACETATE |
| 002 | TABLET;ORAL | 500MG | 0 | ABIRATERONE ACETATE | ABIRATERONE ACETATE |
FDA Submissions
| UNKNOWN; | ORIG | 1 | AP | 2018-10-31 | STANDARD |
| LABELING; Labeling | SUPPL | 3 | AP | 2019-11-01 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 4 | AP | 2020-12-14 | UNKNOWN |
| LABELING; Labeling | SUPPL | 6 | AP | 2022-08-31 | STANDARD |
| LABELING; Labeling | SUPPL | 9 | AP | 2022-08-31 | STANDARD |
Submissions Property Types
| ORIG | 1 | Null | 15 |
| SUPPL | 3 | Null | 7 |
| SUPPL | 4 | Null | 7 |
| SUPPL | 6 | Null | 7 |
| SUPPL | 9 | Null | 7 |
TE Codes
| 001 | Prescription | AB |
| 002 | Prescription | AB |
CDER Filings
MYLAN
cder:Array
(
[0] => Array
(
[ApplNo] => 208446
[companyName] => MYLAN
[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\\\/208446Orig1s000ltr.pdf\"}]","notes":"> Label is not available on this site."}]
[supplements] => [{"actionDate":"11\/01\/2019","submission":"SUPPL-3","supplementCategories":"Labeling-Package Insert, Labeling-Patient Package Insert","inserts":"[]","notes":"> Label is not available on this site."}]
[actionDate] => 2019-11-01
)
)