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Setid F61a1a40 3221 4345 B60d A850eab7945d Applno 12813 Form Suspension Ophthalmic Dosage 0 2 10 - Drug Product Composition: Blefamide

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

USFDA APPLICATION NUMBER - 12813 / DOSAGE - SUSPENSION;OPHTHALMIC - 0.2%;10%

Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
prednisolone acetate(UNII: 8B2807733D)
(prednisolone - UNII:9PHQ9Y1OLM)
prednisolone acetate2mg in 1
sulfacetamide sodium(UNII: 4NRT660KJQ)
(sulfacetamide - UNII:4965G3J0F5)
sulfacetamide sodium100mg in 1

Inactive Ingredients

Ingredient Name
A-S Medication Solutions LLC
Allergan, Inc.
benzalkonium chloride(F5UM2KM3W7)
edetate disodium(7FLD91C86K)
hydrochloric acid(QTT17582CB)
polysorbate 80(6OZP39ZG8H)
polyvinyl alcohol(532B59J990) 
POLYVINYL ALCOHOL, UNSPECIFIED(532B59J990) 
potassium phosphate, monobasic(4J9FJ0HL51)
sodium hydroxide(55X04QC32I)
sodium phosphate, dibasic(GR686LBA74) 
SODIUM PHOSPHATE, DIBASIC, UNSPECIFIED FORM(GR686LBA74) 
sodium thiosulfate(HX1032V43M)
water(059QF0KO0R)