ANDA 208432, held by Teva Pharms USA. Abiraterone Acetate.
As of Nov 15, 2026, ANDA 208432 (Abiraterone Acetate), held by Teva Pharms USA, was first approved by FDA on Oct 31, 2018, with 2 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Oct 31, 2018 | Original application | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Abiraterone Acetate250MG · tablet;oral | Abiraterone Acetate | Discontinued |
| May 18, 2022 | Supplement 1Labeling · Standard review | Approved | None posted |
| May 18, 2022 | Supplement 4Labeling · Standard review | Approved | None posted |
| Oct 31, 2018 | Original application | Approved |
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
