Registrants1
Companies and organizations registered with the FDA for this drug approval, including their contact information and regulatory details.
Bryant Ranch Prepack
171714327
Manufacturing Establishments1
FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.
Bryant Ranch Prepack
Bryant Ranch Prepack
Bryant Ranch Prepack
171714327
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
63629-8773Application Number
NDA018810Marketing Category
NDA (C73594)Route of Administration
TOPICALEffective Date
September 1, 2021Silver sulfadiazineActive
Code: W46JY43EJRClass: ACTIBQuantity: 10 mg in 1 g
WATERInactive
Code: 059QF0KO0RClass: IACT
STEARYL ALCOHOLInactive
Code: 2KR89I4H1YClass: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3Class: IACT
PETROLATUMInactive
Code: 4T6H12BN9UClass: IACT
POLYOXYL 40 STEARATEInactive
Code: 13A4J4NH9IClass: IACT
ISOPROPYL MYRISTATEInactive
Code: 0RE8K4LNJSClass: IACT
METHYLPARABENInactive
Code: A2I8C7HI9TClass: IACTQuantity: 3 mg in 1 g
SORBITAN MONOOLEATEInactive
Code: 06XEA2VD56Class: IACT