Sulfacetamide Sodium

Treats conjunctivitis and other superficial ocular infections due to susceptible…. ANDA 89560, held by Chartwell Rx. Sulfacetamide Sodium.

As of Nov 15, 2026, ANDA 89560 (Sulfacetamide Sodium), held by Chartwell Rx, was first approved by FDA on Oct 18, 1988, with 11 approved supplements and 0 published complete response letters.

First approved: Oct 18, 1988
Supplements approved: 11
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

INDICATIONS AND USAGE: Sulfacetamide Sodium Ophthalmic Solution USP, 10% is indicated for the treatment of conjunctivitis and other superficial ocular infections due to susceptible microorganisms, and as an adjunctive in systemic sulfonamide therapy of trachoma: Escherichia coli, Staphylococcus aureus, Streptococcus pneumoniae, Streptococcus (viridans group), Haemophilus influenzae, Klebsiella species, and Enterobacter species. Topically applied sulfonamides do not provide adequate coverage against Neisseria species, Serratia marcescens and Pseudomonas aeruginosa. A significant percentage of staphylococcal isolates are completely resistant to sulfa drugs.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 12 submissions below

Date	Submission	Status	Documents
Oct 18, 1988	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Sulfacetamide Sodium10% · solution/drops;ophthalmic	Sulfacetamide Sodium	Rx

All 12 submissions, including labeling and manufacturing supplements


May 20, 2003	Supplement 19Labeling	Approved	None posted
Jan 24, 2003	Supplement 18Labeling	Approved	None posted
Feb 19, 1999	Supplement 12Manufacturing	Approved	None posted
Feb 2, 1999	Supplement 11Manufacturing	Approved	None posted
Apr 16, 1996	Supplement 10Manufacturing	Approved	None posted
May 8, 1995	Supplement 9Manufacturing	Approved	None posted
May 17, 1993	Supplement 6Manufacturing	Approved	None posted
Nov 8, 1989	Supplement 3Labeling	Approved	None posted
Nov 8, 1989	Supplement 30Labeling	Approved	None posted
May 9, 1989	Supplement 1Manufacturing	Approved	None posted
May 9, 1989	Supplement 2Manufacturing	Approved	None posted
Oct 18, 1988	Original application	Approved	None posted

Identifiers

Application: ANDA 89560
Drugs@FDA: Overview at FDA
Company: Chartwell 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