Controls serum phosphorus levels. ANDA 212563, held by Teva Pharms USA. Ferric Citrate.
As of Nov 15, 2026, ANDA 212563 (Ferric Citrate), held by Teva Pharms USA, was first approved by FDA on Mar 11, 2026, with 0 approved supplements and 0 published complete response letters.
Ferric citrate tablets are a phosphate binder indicated for the control of serum phosphorus levels in adult patients with chronic kidney disease on dialysis. Ferric citrate tablets are an iron replacement product indicated for the treatment of iron deficiency anemia in adult patients with chronic kidney disease not on dialysis. 1.1 Hyperphosphatemia in Chronic Kidney Disease on Dialysis
| Date | Submission | Status | Documents |
|---|---|---|---|
| Mar 11, 2026 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Ferric CitrateEQ 210MG IRON · tablet;oral | Ferric Citrate | 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
