Manufacturing Establishments1
FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.
Unit Dose Services
Unit Dose Services
831995316
Products1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Silver Sulfadiazine
Product Details
NDC Product Code
50436-1240Application Number
NDA018810Marketing Category
NDA (C73594)Route of Administration
TOPICALEffective Date
December 6, 2017Silver sulfadiazineActive
Code: W46JY43EJRClass: ACTIBQuantity: 10 mg in 1 g
WaterInactive
Code: 059QF0KO0RClass: IACT
Stearyl AlcoholInactive
Code: 2KR89I4H1YClass: IACT
PetrolatumInactive
Code: 4T6H12BN9UClass: IACT
Propylene GlycolInactive
Code: 6DC9Q167V3Class: IACT
Polyoxyl 40 StearateInactive
Code: 13A4J4NH9IClass: IACT
Isopropyl MyristateInactive
Code: 0RE8K4LNJSClass: IACT
Sorbitan MonooleateInactive
Code: 06XEA2VD56Class: IACT
MethylparabenInactive
Code: A2I8C7HI9TClass: IACTQuantity: 3 mg in 1 g