ANDA 209227, held by Glenmark Speclt. Abiraterone Acetate.
As of Nov 15, 2026, ANDA 209227 (Abiraterone Acetate), held by Glenmark Speclt, was first approved by FDA on Oct 16, 2019, with 3 approved supplements 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 |
|---|---|---|---|
| Oct 16, 2019 | Original application | Approved |
| Abiraterone Acetate250MG · tablet;oral | Abiraterone Acetate | Rx |
| Abiraterone Acetate500MG · tablet;oral | Abiraterone Acetate | Rx |
| May 19, 2022 | Supplement 4Manufacturing | Approved | None posted |
| Nov 12, 2021 | Supplement 3Labeling · Standard review | Approved | None posted |
| Apr 5, 2021 | Supplement 2Labeling · Standard review | Approved | None posted |
| Oct 16, 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
