Treats salt-losing adrenogenital syndrome. ANDA 219251, held by Zydus Lifesciences. Fludrocortisone Acetate.
As of Nov 15, 2026, ANDA 219251 (Fludrocortisone Acetate), held by Zydus Lifesciences, was first approved by FDA on Oct 16, 2024, with 0 approved supplements and 0 published complete response letters.
INDICATIONS AND USAGE Fludrocortisone acetate tablets 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 |
|---|---|---|---|
| Oct 16, 2024 | 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
