ANDA 208371, held by Rising. Abiraterone Acetate.
As of Nov 15, 2026, ANDA 208371 (Abiraterone Acetate), held by Rising, was first approved by FDA on Feb 25, 2019, with 1 approved supplement and 0 published complete response letters.
Abiraterone acetate tablets are indicated in combination with prednisone for the treatment of patients with
| Date | Submission | Status | Documents |
|---|---|---|---|
| Feb 25, 2019 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Abiraterone Acetate250MG · tablet;oral | Abiraterone Acetate | Rx |
| Jun 5, 2026 | Supplement 5Labeling · Standard review | Approved | None posted |
| Feb 25, 2019 | Original application | Approved | None posted |
Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters
