Sulfacetamide Sodium

Treats conjunctivitis and other superficial ocular infections due to susceptible…. ANDA 40066, held by Bausch And Lomb. Sulfacetamide Sodium.

As of Nov 15, 2026, ANDA 40066 (Sulfacetamide Sodium), held by Bausch And Lomb, was first approved by FDA on Dec 28, 1994, with 12 approved supplements and 0 published complete response letters.

First approved: Dec 28, 1994
Supplements approved: 12
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 13 submissions below

Date	Submission	Status	Documents
Dec 28, 1994	Original application	Approved	None posted

Products

1 strengths and forms

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

All 13 submissions, including labeling and manufacturing supplements


Nov 27, 2001	Supplement 12Manufacturing	Approved	None posted
Mar 7, 2001	Supplement 11Manufacturing	Approved	None posted
Oct 5, 2000	Supplement 10Manufacturing	Approved	None posted
Jun 27, 2000	Supplement 9Manufacturing	Approved	None posted
May 18, 2000	Supplement 6Manufacturing	Approved	None posted
May 15, 2000	Supplement 8Manufacturing	Approved	None posted
Apr 28, 2000	Supplement 7Manufacturing	Approved	None posted
Jun 7, 1999	Supplement 5Manufacturing	Approved	None posted
Nov 19, 1998	Supplement 4Manufacturing	Approved	None posted
Mar 13, 1998	Supplement 3Manufacturing	Approved	None posted
Jun 28, 1995	Supplement 1Manufacturing	Approved	None posted
May 9, 1995	Supplement 2Manufacturing	Approved	None posted
Dec 28, 1994	Original application	Approved	None posted

Identifiers

Application: ANDA 40066
Drugs@FDA: Overview at FDA
Company: Bausch & Lomb

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