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 | 2019-01-07 | STANDARD |
| LABELING; Labeling | SUPPL | 3 | AP | 2019-11-04 | STANDARD |
| LABELING; Labeling | SUPPL | 10 | AP | 2020-11-20 | STANDARD |
| LABELING; Labeling | SUPPL | 14 | AP | 2022-09-02 | STANDARD |
Submissions Property Types
| ORIG | 1 | Null | 15 |
| SUPPL | 3 | Null | 7 |
| SUPPL | 10 | Null | 15 |
| SUPPL | 14 | Null | 7 |
TE Codes
| 001 | Prescription | AB |
| 002 | Prescription | AB |
CDER Filings
AMNEAL PHARMS
cder:Array
(
[0] => Array
(
[ApplNo] => 208327
[companyName] => AMNEAL PHARMS
[docInserts] => ["",""]
[products] => [{"drugName":"ABIRATERONE ACETATE","activeIngredients":"ABIRATERONE ACETATE","strength":"250MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"01\/07\/2019","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2017\\\/208327Orig1s000TAltr.pdf\"}]","notes":"> Label is not available on this site."}]
[supplements] => [{"actionDate":"11\/04\/2019","submission":"SUPPL-3","supplementCategories":"Labeling-Patient Package Insert, Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."}]
[actionDate] => 2019-11-04
)
)