ANDA 91302, held by Hikma Pharms. Fludrocortisone Acetate.
As of Nov 15, 2026, ANDA 91302 (Fludrocortisone Acetate), held by Hikma Pharms, was first approved by FDA on Jul 22, 2011, with 0 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jul 22, 2011 | 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
