ANDA 204726, held by Chartwell Rx. Silodosin.
As of Nov 14, 2026, ANDA 204726 (Silodosin), held by Chartwell Rx, was first approved by FDA on Mar 31, 2017, with 1 approved supplement and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Mar 31, 2017 | Original application | Approved |
| Jul 21, 2021 | Supplement 5Labeling · Standard review | Approved | None posted |
| Mar 31, 2017 | 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
