ANDA 216013, held by Chartwell Rx. Fludrocortisone Acetate.
As of Nov 15, 2026, ANDA 216013 (Fludrocortisone Acetate), held by Chartwell Rx, was first approved by FDA on Oct 27, 2022, with 0 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Oct 27, 2022 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Fludrocortisone Acetate0.1MG ยท tablet;oral | Fludrocortisone Acetate | Discontinued |
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
