Sulfacetamide Sodium

ANDA 89068, held by Alcon Pharms Ltd. Sulfacetamide Sodium.

As of Nov 15, 2026, ANDA 89068 (Sulfacetamide Sodium), held by Alcon Pharms Ltd, was first approved by FDA on May 5, 1987, with 9 approved supplements and 0 published complete response letters.

First approved: May 5, 1987
Supplements approved: 9
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 10 submissions below

Date	Submission	Status	Documents
May 5, 1987	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Sulfacetamide Sodium30% · solution/drops;ophthalmic	Sulfacetamide Sodium	Discontinued

All 10 submissions, including labeling and manufacturing supplements


Feb 19, 1999	Supplement 13Manufacturing	Approved	None posted
Feb 2, 1999	Supplement 11Manufacturing	Approved	None posted
Dec 4, 1996	Supplement 10Manufacturing	Approved	None posted
Apr 16, 1996	Supplement 9Manufacturing	Approved	None posted
May 8, 1995	Supplement 8Manufacturing	Approved	None posted
May 17, 1993	Supplement 5Manufacturing	Approved	None posted
Mar 27, 1989	Supplement 3Labeling	Approved	None posted
Oct 28, 1988	Supplement 1Manufacturing	Approved	None posted
Oct 28, 1988	Supplement 2Manufacturing	Approved	None posted
May 5, 1987	Original application	Approved	None posted

Identifiers

Application: ANDA 89068
Drugs@FDA: Overview at FDA
Company: Alcon Pharmaceuticals Ltd

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