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Setid 828d5862 C8ac 40a8 B161 9734dd0aec29 Applno 18578 Form Cream Topical Dosage 1 - Drug Product Composition: Silver Sulfadiazine

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$ API Ref.Price (USD/KG) : 389Xls

USFDA APPLICATION NUMBER - 18578 / DOSAGE - CREAM;TOPICAL - 1%

Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
SILVER SULFADIAZINE(UNII: W46JY43EJR)
(SULFADIAZINE - UNII:0N7609K889)
SILVER SULFADIAZINE10g in 1000

Inactive Ingredients

Ingredient Name
A-S Medication Solutions
Actavis Pharma, Inc.
REMEDYREPACK INC.
Unit Dose Services
Lake Erie Medical DBA Quality Care Products LLC
Medsource Pharmaceuticals
NuCare Pharmaceuticals,Inc.
REMEDYREPACK INC.
CETYL ALCOHOL(936JST6JCN)    
Isopropyl Myristate(0RE8K4LNJS) 
METHYLPARABEN(A2I8C7HI9T) 
PETROLATUM(4T6H12BN9U) 
POLYOXYL 40 STEARATE(13A4J4NH9I) 
PROPYLENE GLYCOL(6DC9Q167V3) 
SODIUM HYDROXIDE(55X04QC32I)    
SORBITAN MONOOLEATE(06XEA2VD56) 
STEARYL ALCOHOL(2KR89I4H1Y) 
WATER(059QF0KO0R)