Treats salt-losing adrenogenital syndrome. ANDA 220308, held by Adaptis. Fludrocortisone Acetate.
As of Nov 15, 2026, ANDA 220308 (Fludrocortisone Acetate), held by Adaptis, was first approved by FDA on Feb 10, 2026, 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 |
|---|---|---|---|
| Feb 10, 2026 | Original application | Approved | None posted |
| 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
