ANDA 40425, held by Barr. Fludrocortisone Acetate.
As of Nov 15, 2026, ANDA 40425 (Fludrocortisone Acetate), held by Barr, was first approved by FDA on Jan 21, 2003, with 0 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jan 21, 2003 | 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
