Sulfadiazine

Overview

One of the short-acting sulfonamides used in combination with pyrimethamine to treat toxoplasmosis in patients with acquired immunodeficiency syndrome and in newborns with congenital infections.

Indication

For the treatment of rheumatic fever and meningococcal meningitis

Associated Conditions

Acute Otitis Media caused by Haemophilus Influenzae
Chancroid
Conjunctivitis, Inclusion
Encephalitis
Malaria caused by Plasmodium falciparum
Meningitis caused by Haemophilus influenzae
Meningococcal Meningitis
Nocardiosis
Trachoma
Urinary Tract Infection
Wound Infections
Recurrent Rheumatic fever

Clinical Trials

Title	Posted	Study ID	Phase	Status	Sponsor
Phase 1-2 Study of Low Dose ASTX727 (ASTX727 LD) in Lower Risk MDS	2018/04/19	NCT03502668	Phase 1	Active, not recruiting	Taiho Oncology, Inc.
Single Rising Dose Study Investigating the Safety, Tolerability and Pharmacokinetics of Spray Dried BIBN 4096 BS After Inhalation Administration in Healthy Male and Female Volunteers	2014/07/25	NCT02199860	Phase 1	Completed	Boehringer Ingelheim
Study of GSK961081 in Healthy Volunteer Subjects	2009/04/24	NCT00887406	Phase 1	Completed	Theravance Biopharma
Phase II Randomized Open-Label Trial of Atovaquone Plus Pyrimethamine and Atovaquone Plus Sulfadiazine for the Treatment of Acute Toxoplasmic Encephalitis	2001/08/31	NCT00000794	Phase 2	Completed	National Institute of Allergy and Infectious Diseases (NIAID)
Pyrimethamine, Sulfadiazine, and Leucovorin in Treating Patients With Congenital Toxoplasmosis	1999/10/19	NCT00004317	Phase 4	Recruiting	National Institute of Allergy and Infectious Diseases (NIAID)

FDA Drug Approvals

Approved Product	Manufacturer	NDC Code	Route	Strength	Effective Date
SULFADIAZINE	EPIC PHARMA, LLC	42806-757	ORAL	500 mg in 1 1	12/15/2021
Sulfadiazine	Eon Labs, Inc.	0185-0757	ORAL	500 mg in 1 1	6/30/2020

EMA Drug Approvals

Approved Product	Authorization Holder	Status	Issued Date
No EMA approvals found for this drug.

HSA Drug Approvals

Approved Product	Manufacturer	Approval Number	Dosage Form	Strength	Approval Date
No HSA approvals found for this drug.

NMPA Drug Approvals

Approved Product	Company	Approval Number	Drug Type	Dosage Form	Approval Date
No NMPA approvals found for this drug.

PPB Drug Approvals

Approved Product	Registration No.	Company	Licence No.	Strength	Registration Date
FLUODERMA CREAM	N/A	MARCHING PHARMACEUTICAL LIMITED	N/A	N/A	2/1/1996
FOURDERM CREAM	N/A	MARCHING PHARMACEUTICAL LIMITED	N/A	N/A	1/13/1989
SINOCORT CREAM	N/A	MARCHING PHARMACEUTICAL LIMITED	N/A	N/A	2/8/1996
PAFULIMA CREAM	N/A	MARCHING PHARMACEUTICAL LIMITED	N/A	N/A	2/8/1996
TRIDAZINE CREAM	N/A	MARCHING PHARMACEUTICAL LIMITED	N/A	N/A	2/8/1996
DERMASOL CREAM	N/A	MARCHING PHARMACEUTICAL LIMITED	N/A	N/A	2/8/1996
FUNGACIN CREAM	N/A	MARCHING PHARMACEUTICAL LIMITED	N/A	N/A	2/1/1996
FUOGORTE-F CREAM	N/A	MARCHING PHARMACEUTICAL LIMITED	N/A	N/A	4/20/1983
INFRADERMA CREAM	N/A	MARCHING PHARMACEUTICAL LIMITED	N/A	N/A	6/20/1989
GATE CREAM	N/A	MARCHING PHARMACEUTICAL LIMITED	N/A	N/A	1/13/1989

TGA Drug Approvals

Approved Product	ARTG ID	Sponsor	Registration Type	Status	Registration Date
No TGA approvals found for this drug.

Health Canada Drug Approvals

Approved Product	Company	DIN	Dosage Form	Strength	Market Date
OVOQUINOL CONES	lab nadeau ltée, division of technilab inc.	00522074	Suppository - Vaginal	400 MG / SUP	12/31/1963
COPTIN TAB	Pfizer Canada Ulc	00478717	Tablet - Oral	410 MG / TAB	12/31/1979
TRISULFAMINIC TAB	shepherd pharmaceuticals inc.	00889210	Tablet - Oral	167 MG	12/31/1959
SULFADIAZINE TAB 7.7GR	stanley pharmaceuticals, a division of vita health products inc.	00178861	Tablet - Oral	500.5 MG / TAB	12/31/1957
COPTIN ORAL SUSPENSION	axcan pharma inc	00745618	Suspension - Oral	41 MG / ML	12/31/1979
OVOQUINOL CRM VAGINALE	lab nadeau ltée, division of technilab inc.	00464651	Cream - Vaginal	8 %	12/31/1980
TRISULFAMINIC SUS	shepherd pharmaceuticals inc.	00889202	Suspension - Oral	167 MG / 5 ML	12/31/1959
COPTIN TAB	axcan pharma inc	00656933	Tablet - Oral	410 MG	12/31/1979

CIMA AEMPS Drug Approvals

Approved Product	Company	Registration Number	Pharmaceutical Form	Prescription Type	Status
SULFADIAZINA REIG JOFRE 500 MG COMPRIMIDOS	Laboratorio Reig Jofre, S.A.	06960	COMPRIMIDO	Medicamento Sujeto A Prescripción Médica	Commercialized

Philippines FDA Drug Approvals

Approved Product	Company	License Number	Dosage Form	Strength	Approval Date
No Philippines FDA approvals found for this drug.

Saudi SFDA Drug Approvals

Approved Product	Company	License Number	Dosage Form	Strength	Approval Date
No Saudi SFDA approvals found for this drug.

Malaysia NPRA Drug Approvals

Approved Product	Company	Registration Number	Dosage Form	Strength	Approval Date
No Malaysia NPRA approvals found for this drug.

UK EMC Drug Information

Medicine Name	MA Holder	MA Number	Pharmaceutical Form	Active Ingredient	Authorization Date
No UK EMC drug information found for this drug.

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