Controls serum phosphorus. ANDA 204724, held by Glenmark Pharms Ltd. Sevelamer Hydrochloride.
As of Nov 15, 2026, ANDA 204724 (Sevelamer Hydrochloride), held by Glenmark Pharms Ltd, was first approved by FDA on Feb 8, 2019, with 0 approved supplements and 0 published complete response letters.
1. INDICATIONS AND USAGE 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 8, 2019 | Original application | Approved |
| 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
