Controls serum phosphorus. ANDA 206883, held by Macleods Pharms. Sevelamer Hydrochloride.
As of Nov 15, 2026, ANDA 206883 (Sevelamer Hydrochloride), held by Macleods Pharms, was first approved by FDA on May 26, 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 |
|---|---|---|---|
| May 26, 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
