ANDA 208380, held by Wockhardt Bio AG. Abiraterone Acetate.
As of Nov 15, 2026, ANDA 208380 (Abiraterone Acetate), held by Wockhardt Bio AG, was first approved by FDA on Feb 27, 2019, with 1 approved supplement and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Feb 27, 2019 | Original application | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Abiraterone Acetate250MG · tablet;oral | Abiraterone Acetate | Rx |
| Nov 28, 2023 | Supplement 4Labeling · Standard review | Approved | None posted |
| Feb 27, 2019 | 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
