Sulfadiazine

Sold as Sulfadiazine. Every FDA application for this active ingredient: 3 branded and 4 generic.

As of Nov 15, 2026, FDA lists 7 applications for Sulfadiazine (sold as Sulfadiazine), first approved Aug 11, 1941, with 0 new uses approved and 0 published complete response letters.

First approved: Aug 11, 1941
Applications: 7
New uses approved: 0
Complete response letters: 0
Medicare spending, 2025: $884K

Medicare Spending

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

Product	Part	Spending, 2025	Change	Beneficiaries
Sulfadiazine	Part D	$884K	+16%	201

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

SULFADIAZINE 500 MG TABLET: $15.05 per unitGeneric · new this year

Orphan Designations (FDA)

One designation, 1 approved for the designated use; see all orphan designations

For use in combination with pyrimethamine for the treatment of Toxoplasma gondii encephalitis in patients with and…Eon Labs Manufacturing, Inc. · designated Mar 14, 1994 · approved Jul 29, 1994

Clinical Trials

5 open or ongoing studies name this ingredient as an intervention, including as a comparator; newest first. See all


Comparison of Topical Antibiotics Versus Systemic Antibiotics in Preventing Burn Wound Infection in Pediatric Burn PatientsBurn · abdul mateen	Not applicable	Not yet recruiting	Oct 13, 2026
Microenvironment in Patients Undergoing Non-traumatic AmputationLower Limb Amputation Above Knee · University of Aarhus	Not applicable	Recruiting	Feb 3, 2026
Silver Sulfadiazine With Hyaluronic Acid Versus Silver Sulfadiazine Alone in Partial-Thickness BurnsPartial-Thickness Burn, Thermal Burn · Dr Muhammad Naveed Shahzad	Not applicable	Not yet recruiting	Jan 26, 2026
Phase 2 Pilot Study of the Safety and Efficacy of Topical MW-III in Thermal BurnsBurns · Skingenix, Inc.	Phase 2	Recruiting	Feb 16, 2011
Pyrimethamine, Sulfadiazine, and Leucovorin in Treating Patients With Congenital ToxoplasmosisToxoplasmosis · National Institute of Allergy and Infectious Diseases (NIAID)	Phase 4	Recruiting	Oct 19, 1999

Applications

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


Aug 11, 1941	Sulfadiazine, Sulfadiazine SodiumNDA 4054	Lederle	5	Discontinued
Aug 26, 1941	SulfadiazineNDA 4122 · New formulation or manufacturer	Lilly	3	Discontinued
Jul 5, 1978	SulfadiazineANDA 80084	Chartwell Molecular	7	Discontinued
Jul 29, 1994	SulfadiazineANDA 40091	Epic Pharma LLC	7	Marketed
—	SulfadiazineANDA 80081	Impax Labs	0	Discontinued
—	SulfadiazineANDA 80088	Everylife	0	Discontinued
—	SulfadiazineNDA 4125	Abbvie	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