Silver sulfadiazine

Generic Name: Silver sulfadiazine

Brand Names: Flamazine, Silvadene, Ssd, Thermazene

Drug Type: Small Molecule

Chemical Formula: C_₁₀H_₉AgN_₄O_₂S

CAS Number: 22199-08-2

Unique Ingredient Identifier: W46JY43EJR

Overview

Silver sulfadiazine is a sulfa derivative topical antibacterial used primarily on second- and third-degree burns.

Indication

Indicated as an adjunct for the prevention and treatment of wound sepsis in patients with second- and third-degree burns.

Associated Conditions

Wound Infections

Clinical Trials

Title	Posted	Study ID	Phase	Status	Sponsor
SWC for Treatment of Superficial Partial-Thickness Burns	2023/05/26	NCT05877638	Not Applicable	Terminated	Synedgen, Inc.
StrataXRT for the Prevention and Treatment of Radiation Dermatitis in Breast Cancer or Head and Neck Cancer Patients	2021/10/11	NCT05073172	Not Applicable	Withdrawn	OHSU Knight Cancer Institute
Superficial Partial-Thickness Burn Study	2020/10/23	NCT04601532	Phase 4	Terminated	J. Peter Rubin, MD
Comparative Analysis of Cost-effectiveness of Silver Dressing in Burns	2014/04/09	NCT02108535	Phase 4	Completed	University of Sorocaba
Comparison of a Water-soluble Topical Antimicrobial to Silver Sulfadiazine in Partial Thickness Burns	2013/08/20	NCT01926392	Phase 4	Completed	University of Virginia
To Study the Healing Effect of Silver Impregnated Activated Carbon Fiber Wound Dressing on Deep Dermal Burn	2012/05/15	NCT01598493	Not Applicable	Completed	Bio-medical Carbon Technology Co., Ltd.
To Study the Healing Effect of Silver Impregnated Activated Carbon Fiber Wound Dressing on Superficial Dermal Burn	2012/05/15	NCT01598480	Not Applicable	Completed	Bio-medical Carbon Technology Co., Ltd.
Phase 2 Pilot Study of the Safety and Efficacy of Topical MW-III in Thermal Burns	2011/02/16	NCT01297400	Phase 2	Recruiting	Skingenix, Inc.

FDA Drug Approvals

Approved Product	Manufacturer	NDC Code	Route	Strength	Effective Date
Silver Sulfadiazine	Bryant Ranch Prepack	63629-8773	TOPICAL	10 mg in 1 g	9/1/2021
Silver Sulfadiazine	Unit Dose Services	50436-1240	TOPICAL	10 mg in 1 g	12/6/2017
Silver Sulfadiazine	Bryant Ranch Prepack	63629-8769	TOPICAL	10 mg in 1 g	9/1/2021
Silver Sulfadiazine	NuCare Pharmaceuticals,Inc.	68071-4481	TOPICAL	10 mg in 1 g	2/16/2021
Silver Sulfadiazine	NuCare Pharmaceuticals,Inc.	68071-2473	TOPICAL	10 g in 1000 g	7/8/2021
Silver Sulfadiazine	Liberty Pharmaceuticals, Inc.	0440-0124	TOPICAL	10 mg in 1 g	7/27/2016
Silver Sulfadiazine	Bryant Ranch Prepack	63629-8771	TOPICAL	10 mg in 1 g	9/1/2021
Silver Sulfadiazine	REMEDYREPACK INC.	70518-1562	TOPICAL	10 mg in 1 g	2/21/2024
SSD	STAT Rx USA LLC	16590-206	TOPICAL	10 g in 1000 g	8/15/2012
Silver Sulfadiazine	A-S Medication Solutions	50090-0717	TOPICAL	10 mg in 1 g	12/6/2017

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
SILVIN CREAM	ICM PHARMA PTE. LTD.	SIN10131P	CREAM	1% w/v	10/2/1998

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
SILVER SULFADIAZINE CREAM 1%	N/A	WILCOME PHARMACEUTICAL COMPANY LIMITED	N/A	N/A	7/30/1988

TGA Drug Approvals

Approved Product	ARTG ID	Sponsor	Registration Type	Status	Registration Date
FLAMAZINE silver sulfadiazine 1.0% w/w cream tube	159342	Smith & Nephew Pty Ltd	Medicine	A	6/11/2010
66800531 FLAMAZINE TUBE 50G New Zealand	381890	Smith & Nephew Pty Ltd	Medicine	A	1/5/2022
FLAMAZINE silver sulfadiazine 1.0% w/w cream jar	159338	Smith & Nephew Pty Ltd	Medicine	A	6/11/2010

Health Canada Drug Approvals

Approved Product	Company	DIN	Dosage Form	Strength	Market Date
FLAMAZINE	Smith & Nephew Inc	00323098	Cream - Topical	1 %	12/31/1974
FLAMAZINE C	Smith & Nephew Inc	00714917	Cream - Topical	10 MG / G	12/31/1987
SSD (1% SILVER SULFADIAZINE CREAM USP)	ABBOTT LABORATORIES, LIMITED	02170310	Cream - Topical	1 %	12/31/1996
DERMAZIN CRM 1%	Pharmascience Inc	02010917	Cream - Topical	1 %	12/31/1993
SSD SILVER SULFADIAZINE CRM 1%	boots company plc nottingham england	01913115	Cream - Topical	1 %	12/31/1991

CIMA AEMPS Drug Approvals

Approved Product	Company	Registration Number	Pharmaceutical Form	Prescription Type	Status
No CIMA AEMPS (Spain) approvals found for this drug.

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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