ANDA 75818, held by Chartwell Rx. Flutamide.
As of Nov 14, 2026, ANDA 75818 (Flutamide), held by Chartwell Rx, was first approved by FDA on Sep 18, 2001, with 3 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Sep 18, 2001 | Original application | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Flutamide125MG ยท capsule;oral | Flutamide | Discontinued |
| Apr 25, 2012 | Supplement 6Labeling | Approved | None posted |
| Sep 20, 2002 | Supplement 2Manufacturing | Approved | None posted |
| Sep 5, 2002 | Supplement 1Labeling | Approved | None posted |
| Sep 18, 2001 | 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
