Treats hyperkalemia. ANDA 89910, held by Cmp Pharma Inc. Sodium Polystyrene Sulfonate.
As of Nov 15, 2026, ANDA 89910 (Sodium Polystyrene Sulfonate), held by Cmp Pharma Inc, was first approved by FDA on Jan 19, 1989, with 5 approved supplements and 0 published complete response letters.
SODIUM POLYSTYRENE SULFONATE FOR SUSPENSION is indicated for the treatment of hyperkalemia. SODIUM POLYSTYRENE SULFONATE FOR SUSPENSION is a potassium binder indicated for the treatment of hyperkalemia. Limitation of Use: SODIUM POLYSTYRENE SULFONATE FOR SUSPENSION should not be used an emergency treatment for life threatening hyperkalemia because of its delayed onset of action. Limitation of Use: SODIUM POLYSTYRENE SULFONATE FOR SUSPENSION should not be used as an emergency treatment for life-threatening hyperkalemia because of its delayed onset of action.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jan 19, 1989 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Sodium Polystyrene Sulfonate454GM/BOT · powder;oral, rectal | Sodium Polystyrene Sulfonate | Rx |
| Jan 29, 2018 | Supplement 9Labeling · Standard review | Approved | None posted |
| Sep 25, 2012 | Supplement 8Labeling · Standard review | Approved | None posted |
| Oct 31, 2000 | Supplement 5Manufacturing | Approved | None posted |
| Nov 4, 1992 | Supplement 4Labeling | Approved | None posted |
| Dec 4, 1991 | Supplement 3Manufacturing | Approved | None posted |
| Jan 19, 1989 | Original application | Approved | None posted |
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
