Treats Metastatic castration-resistant prostate cancer (CRPC) … prostate cancer (CSPC). ANDA 215086, held by Regcon Holdings. Abiraterone Acetate.
As of Nov 15, 2026, ANDA 215086 (Abiraterone Acetate), held by Regcon Holdings, was first approved by FDA on Mar 23, 2023, with 0 approved supplements and 0 published complete response letters.
Abiraterone acetate tablets are indicated in combination with prednisone for the treatment of patients with Metastatic castration-resistant prostate cancer (CRPC) Metastatic high-risk castration-sensitive prostate cancer (CSPC)
| Date | Submission | Status | Documents |
|---|---|---|---|
| Mar 23, 2023 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Abiraterone Acetate500MG · tablet;oral | Abiraterone Acetate | Rx |
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
