Sulfacetamide Sodium

Treats acne vulgaris. Sold as Sodium Sulamyd, Klaron. Every FDA application for this active ingredient: 2 branded and 28 generic.

As of Nov 15, 2026, FDA lists 30 applications for Sulfacetamide Sodium (sold as Sodium Sulamyd, Klaron), first approved Jul 21, 1946, with 0 new uses approved and 0 published complete response letters.

First approved: Jul 21, 1946
Applications: 30
New uses approved: 0
Complete response letters: 0
Medicare spending, 2025: $1.7M

Medicare Spending

CMS Part D and Part B, 2025, before manufacturer rebates; matched by generic name

Product	Part	Spending, 2025	Change	Beneficiaries
Sulfacetamide Sodium	Part D	$1.7M	-12%	21,732

What Pharmacies Pay

Median price per unit across package codes in CMS's weekly NADAC survey, Nov 11, 2026, before rebates; see every drug's price change

SODIUM SULFACETAMIDE 10% WASH: $0.109 per GMGeneric · -15% in a year
SULFACETAMIDE 10% EYE DROPS: $1.97 per MLGeneric · -2% in a year

Applications

NDAs, BLAs and generic ANDAs for this ingredient, oldest first; each opens its full history


Jul 21, 1946	Sodium SulamydNDA 5963	Schering	5	Discontinued
Sep 29, 1970	Sulfacel-15ANDA 80024	Optopics	1	Discontinued
May 5, 1971	Isopto CetamideANDA 80020	Alcon	18	Discontinued
May 25, 1971	Bleph-10, Bleph-30ANDA 80028	Allergan	29	Discontinued
Dec 22, 1971	Sulfacetamide SodiumANDA 80029	Padagis US	13	Discontinued
Aug 24, 1972	Ocusulf-10, Ocusulf-30ANDA 80660	Miza Pharms USA	14	Discontinued
Sep 27, 1972	CetamideANDA 80021	Alcon	14	Discontinued
Nov 1, 1974	Sodium SulfacetamideANDA 84145	Sola Barnes Hind	0	Discontinued
Nov 1, 1974	Sodium SulfacetamideANDA 84146	Sola Barnes Hind	0	Discontinued
Nov 22, 1974	Sodium SulfacetamideANDA 84143	Sola Barnes Hind	0	Discontinued
Dec 10, 1974	Sodium SulfacetamideANDA 84147	Sola Barnes Hind	0	Discontinued
Jan 7, 1975	Bleph-10ANDA 84015	Allergan	18	Discontinued
Dec 22, 1982	Sulfair 10ANDA 88000	Pharmafair	1	Discontinued
Feb 3, 1983	Sulten-10ANDA 87818	Bausch And Lomb	1	Discontinued
May 5, 1987	Sulfacetamide SodiumANDA 89068	Alcon Pharms Ltd	9	Discontinued
Oct 18, 1988	Sulfacetamide SodiumANDA 89560	Chartwell Rx	11	Marketed
Dec 28, 1994	Sulfacetamide SodiumANDA 40066	Bausch And Lomb	12	Marketed
Oct 31, 1995	Sulf-15ANDA 89047	Novartis	0	Discontinued
Dec 23, 1996	KlaronNDA 19931 · New dosage form	Bausch	11	Marketed
May 25, 1999	Sulfacetamide SodiumANDA 40215	Pharmobedient	0	Discontinued
May 25, 1999	Sulfacetamide SodiumANDA 40216	Epic Pharma LLC	0	Discontinued
Nov 17, 2006	Sulfacetamide SodiumANDA 77015	Fougera Pharms	1	Marketed
Mar 23, 2009	Sulfacetamide SodiumANDA 78649	Padagis US	1	Marketed
May 20, 2009	Sulfacetamide SodiumANDA 78668	Sun Pharma Canada	1	Discontinued
—	Sulf-10ANDA 80025	Novartis	0	Discontinued
—	Sodium SulfacetamideANDA 83021	Epic Pharma LLC	0	Discontinued
—	Sulfair 10ANDA 87949	Pharmafair	0	Discontinued
—	Sulfair-15ANDA 88186	Pharmafair	0	Discontinued
—	Sulfair ForteANDA 88385	Pharmafair	0	Discontinued
—	Sulfacetamide SodiumANDA 88947	Pharmafair	0	Discontinued

Applications, approvals and products come from FDA's Drugs@FDA data files, refreshed weekly, grouped by active ingredient as FDA spells it. Complete response letters are FDA's published letters. Medicare spending is CMS's Part D and Part B dashboard, matched to this ingredient by generic name; shortages are FDA's shortage list, matched by application number; clinical trials are ClinicalTrials.gov studies naming the ingredient as an intervention, refreshed daily; safety programs are FDA's REMS list, matched by application number or, for shared programs, by ingredient. Drugs@FDA