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Setid 27c8bd30 89ec 464c B7ac Ca2dbe27e861 Applno 80028 Form Solution Drops Ophthalmic Dosage 10 - Drug Product Composition: Blefamide

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$ API Ref.Price (USD/KG) : 87Xls

USFDA APPLICATION NUMBER - 80028 / DOSAGE - SOLUTION/DROPS;OPHTHALMIC - 10%

Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
sulfacetamide sodium(UNII: 4NRT660KJQ)
(sulfacetamide - UNII:4965G3J0F5)
sulfacetamide sodium100mg in 1

Inactive Ingredients

Ingredient Name
Allergan, Inc.
Pacific Pharma, Inc.
Akorn, Inc.
Lake Erie Medical DBA Quality Care Products LLC
REMEDYREPACK INC.
NuCare Pharmaceuticals,Inc.
Preferred Pharmaceuticals Inc.
benzalkonium chloride(F5UM2KM3W7)     
edetate disodium(7FLD91C86K)     
hydrochloric acid(QTT17582CB)     
Hypromelloses(3NXW29V3WO)      
METHYLCELLULOSE (100 CPS)(4GFU244C4J)     
METHYLCELLULOSE (4000 CPS)(MRJ667KA5E)      
METHYLCELLULOSE (4000 MPA.S)(MRJ667KA5E)      
Methylparaben(A2I8C7HI9T)  
polysorbate 80(6OZP39ZG8H)     
POLYVINYL ALCOHOL, UNSPECIFIED(532B59J990)     
Propylparaben(Z8IX2SC1OH)  
sodium hydroxide(55X04QC32I)     
sodium phosphate, dibasic(GR686LBA74)      
sodium phosphate, dibasic, anhydrous(22ADO53M6F)      
sodium phosphate, monobasic(3980JIH2SW) 
SODIUM PHOSPHATE, MONOBASIC, UNSPECIFIED FORM(3980JIH2SW)      
SODIUM THIOSULFATE(HX1032V43M)
WATER(059QF0KO0R)