Sodium Polystyrene Sulfonate

ANDA 90313, held by Upsher Smith Labs. Sodium Polystyrene Sulfonate.

As of Nov 15, 2026, ANDA 90313 (Sodium Polystyrene Sulfonate), held by Upsher Smith Labs, was first approved by FDA on Dec 21, 2011, with 1 approved supplement and 0 published complete response letters.

First approved: Dec 21, 2011
Supplements approved: 1
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 2 submissions below

Date	Submission	Status	Documents
Dec 21, 2011	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Sodium Polystyrene Sulfonate453.6GM/BOT · powder;oral, rectal	Sodium Polystyrene Sulfonate	Rx

All 2 submissions, including labeling and manufacturing supplements


Feb 25, 2020	Supplement 2Labeling · Standard review	Approved	None posted
Dec 21, 2011	Original application	Approved	None posted

Identifiers

Application: ANDA 90313
Drugs@FDA: Overview at FDA
Company: Upsher-Smith Laboratories

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