Sodium Polystyrene Sulfonate

ANDA 88786, held by Pai Holdings Pharm. Sodium Polystyrene Sulfonate.

As of Nov 15, 2026, ANDA 88786 (Sodium Polystyrene Sulfonate), held by Pai Holdings Pharm, was first approved by FDA on Sep 11, 1984, with 6 approved supplements and 0 published complete response letters.

First approved: Sep 11, 1984
Supplements approved: 6
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 7 submissions below

Date	Submission	Status	Documents
Sep 11, 1984	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	DiscontinuedReference drug

All 7 submissions, including labeling and manufacturing supplements


Nov 8, 1991	Supplement 6Labeling	Approved	None posted
Jan 30, 1990	Supplement 5Labeling	Approved	None posted
Aug 29, 1989	Supplement 4Labeling	Approved	None posted
Mar 6, 1987	Supplement 3Manufacturing	Approved	None posted
Mar 6, 1987	Supplement 2Manufacturing	Approved	None posted
May 23, 1986	Supplement 1Manufacturing	Approved	None posted
Sep 11, 1984	Original application	Approved	None posted

Identifiers

Application: ANDA 88786
Drugs@FDA: Overview at FDA
Company: PAI Holdings Pharm

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