Registrants1
Companies and organizations registered with the FDA for this drug approval, including their contact information and regulatory details.
PSS World Medical Inc.
101822682
Manufacturing Establishments1
FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.
STAT Rx USA LLC
STAT Rx USA LLC
PSS World Medical Inc.
786036330
Products1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
SSD
Product Details
NDC Product Code
16590-206Application Number
NDA018578Marketing Category
NDA (C73594)Route of Administration
TOPICALEffective Date
August 15, 2012CETYL ALCOHOLInactive
Code: 936JST6JCNClass: IACT
PETROLATUMInactive
Code: 4T6H12BN9UClass: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3Class: IACT
WATERInactive
Code: 059QF0KO0RClass: IACT
Silver sulfadiazineActive
Code: W46JY43EJRClass: ACTIBQuantity: 10 g in 1000 g
ISOPROPYL MYRISTATEInactive
Code: 0RE8K4LNJSClass: IACT
METHYLPARABENInactive
Code: A2I8C7HI9TClass: IACTQuantity: 0.3 mg in 1000 g
POLYOXYL 40 STEARATEInactive
Code: 13A4J4NH9IClass: IACT
SORBITAN MONOOLEATEInactive
Code: 06XEA2VD56Class: IACT
STEARYL ALCOHOLInactive
Code: 2KR89I4H1YClass: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32IClass: IACT