Treats hyperkalemia. ANDA 214912, held by Lyne. Sodium Polystyrene Sulfonate.
As of Nov 15, 2026, ANDA 214912 (Sodium Polystyrene Sulfonate), held by Lyne, was first approved by FDA on Jun 10, 2025, with 0 approved supplements and 0 published complete response letters.
INDICATION AND USAGE Sodium Polystyrene Sulfonate Suspension, USP is indicated for the treatment of hyperkalemia.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jun 10, 2025 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Sodium Polystyrene Sulfonate15GM/60ML · suspension;oral, rectal | Sodium Polystyrene Sulfonate | 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
