Controls serum phosphorus. ANDA 213145, held by Lupin. Sevelamer Hydrochloride.
As of Nov 15, 2026, ANDA 213145 (Sevelamer Hydrochloride), held by Lupin, was first approved by FDA on Jun 16, 2021, 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 |
|---|---|---|---|
| Jun 16, 2021 | 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
