Overview
Silver sulfadiazine is a sulfa derivative topical antibacterial used primarily on second- and third-degree burns.
Background
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 |
|---|---|---|---|---|---|
2023/05/26 | Not Applicable | Terminated | |||
2021/10/11 | Not Applicable | Withdrawn | |||
2020/10/23 | Phase 4 | Terminated | J. Peter Rubin, MD | ||
2014/04/09 | Phase 4 | Completed | University of Sorocaba | ||
2013/08/20 | Phase 4 | Completed | |||
2012/05/15 | Not Applicable | Completed | Bio-medical Carbon Technology Co., Ltd. | ||
2012/05/15 | Not Applicable | Completed | Bio-medical Carbon Technology Co., Ltd. | ||
2011/02/16 | Phase 2 | Recruiting |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| Bryant Ranch Prepack | 63629-8773 | TOPICAL | 10 mg in 1 g | 9/1/2021 | |
| Unit Dose Services | 50436-1240 | TOPICAL | 10 mg in 1 g | 12/6/2017 | |
| Bryant Ranch Prepack | 63629-8769 | TOPICAL | 10 mg in 1 g | 9/1/2021 | |
| NuCare Pharmaceuticals,Inc. | 68071-4481 | TOPICAL | 10 mg in 1 g | 2/16/2021 | |
| NuCare Pharmaceuticals,Inc. | 68071-2473 | TOPICAL | 10 g in 1000 g | 7/8/2021 | |
| Liberty Pharmaceuticals, Inc. | 0440-0124 | TOPICAL | 10 mg in 1 g | 7/27/2016 | |
| Bryant Ranch Prepack | 63629-8771 | TOPICAL | 10 mg in 1 g | 9/1/2021 | |
| REMEDYREPACK INC. | 70518-1562 | TOPICAL | 10 mg in 1 g | 2/21/2024 | |
| STAT Rx USA LLC | 16590-206 | TOPICAL | 10 g in 1000 g | 8/15/2012 | |
| 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 | SIN10131P | CREAM | 1% w/v | 10/2/1998 |
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| Sulfadiazine Silver Cream | 国药准字H37020451 | 化学药品 | 乳膏剂 | 4/17/2020 | |
| Sulfadiazine Silver Cream | 国药准字H36020165 | 化学药品 | 乳膏剂 | 5/21/2021 | |
| Sulfadiazine Silver Cream | 国药准字H41021844 | 化学药品 | 乳膏剂 | 5/6/2020 | |
| Sulfadiazine Silver Cream | 国药准字H12020075 | 化学药品 | 乳膏剂 | 6/14/2022 | |
| Sulfadiazine Silver Cream | 国药准字H33020325 | 化学药品 | 乳膏剂 | 3/14/2024 | |
| Sulfadiazine Silver Cream | 国药准字H44020614 | 化学药品 | 乳膏剂 | 5/14/2024 | |
| Sulfadiazine Silver Cream | 国药准字H36021032 | 化学药品 | 乳膏剂 | 6/9/2022 | |
| Sulfadiazine Silver Cream | 国药准字H50021476 | 化学药品 | 乳膏剂 | 4/8/2020 | |
| Sulfadiazine Silver Cream | 国药准字H20057720 | 化学药品 | 乳膏剂 | 4/25/2020 | |
| Sulfadiazine Silver Cream | 国药准字H20094208 | 化学药品 | 乳膏剂 | 6/27/2019 |
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
|---|---|---|---|---|---|
| SILVER SULFADIAZINE CREAM 1% | N/A | 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 | Medicine | A | 6/11/2010 | |
| 66800531 FLAMAZINE TUBE 50G New Zealand | 381890 | Medicine | A | 1/5/2022 | |
| FLAMAZINE silver sulfadiazine 1.0% w/w cream jar | 159338 | Medicine | A | 6/11/2010 |