Controls serum phosphorus. ANDA 212599, held by Aurobindo Pharma Ltd. Sevelamer Hydrochloride.
As of Nov 15, 2026, ANDA 212599 (Sevelamer Hydrochloride), held by Aurobindo Pharma Ltd, was first approved by FDA on Jul 11, 2023, 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 |
|---|---|---|---|
| Jul 11, 2023 | Original application | Approved | None posted |
| Sevelamer Hydrochloride400MG · tablet;oral | Sevelamer Hydrochloride | Rx |
| 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
