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FDA Approval

Silver Sulfadiazine

FDA-approved pharmaceutical product with comprehensive regulatory information, manufacturing details, and complete labeling documentation.

FDA Approval Summary

Company
Effective Date
July 27, 2016
Labeling Type
HUMAN PRESCRIPTION DRUG LABEL
Silver sulfadiazine(10 mg in 1 g)

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
0440-0124
Application Number
NDA018810
Marketing Category
NDA (C73594)
Route of Administration
TOPICAL
Effective Date
July 27, 2016
Code: W46JY43EJRClass: ACTIBQuantity: 10 mg in 1 g
WATERInactive
Code: 059QF0KO0RClass: IACT
STEARYL ALCOHOLInactive
Code: 2KR89I4H1YClass: IACT
PETROLATUMInactive
Code: 4T6H12BN9UClass: IACT
SORBITAN MONOOLEATEInactive
Code: 06XEA2VD56Class: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3Class: IACT
ISOPROPYL MYRISTATEInactive
Code: 0RE8K4LNJSClass: IACT
POLYOXYL 40 STEARATEInactive
Code: 13A4J4NH9IClass: IACT
METHYLPARABENInactive
Code: A2I8C7HI9TClass: IACTQuantity: 3 mg in 1 g
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