Controls serum phosphorus. ANDA 218966, held by Navinta LLC. Sevelamer Hydrochloride.
As of Nov 15, 2026, ANDA 218966 (Sevelamer Hydrochloride), held by Navinta LLC, was first approved by FDA on Feb 3, 2025, with 0 approved supplements and 0 published complete response letters.
Sevelamer hydrochloride tablets are indicated for the control of serum phosphorus in patients with chronic kidney disease (CKD) on dialysis. The safety and efficacy of sevelamer hydrochloride tablets in CKD patients who are not on dialysis have not been studied.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Feb 3, 2025 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Sevelamer Hydrochloride800MG · tablet;oral | Sevelamer Hydrochloride | 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
