Treats salt-losing adrenogenital syndrome. ANDA 40431, held by Impax Labs. Fludrocortisone Acetate.
As of Nov 15, 2026, ANDA 40431 (Fludrocortisone Acetate), held by Impax Labs, was first approved by FDA on Mar 18, 2002, with 0 approved supplements and 0 published complete response letters.
INDICATIONS AND USAGE Fludrocortisone acetate tablets, 0.1 mg are indicated as partial replacement therapy for primary and secondary adrenocortical insufficiency in Addison's disease and for the treatment of salt-losing adrenogenital syndrome.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Mar 18, 2002 | Original application | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Fludrocortisone Acetate0.1MG · tablet;oral | Fludrocortisone Acetate | Rx |
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
