Treats salt-losing adrenogenital syndrome. ANDA 215279, held by Novitium Pharma. Fludrocortisone Acetate.
As of Nov 15, 2026, ANDA 215279 (Fludrocortisone Acetate), held by Novitium Pharma, was first approved by FDA on May 31, 2022, with 0 approved supplements and 0 published complete response letters.
INDICATIONS & 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 |
|---|---|---|---|
| May 31, 2022 | 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
