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    Setid 0c92b04d Deec 4f53 A65b 7f9414b3aa3f Applno 16851 Form Suspension Drops Ophthalmic Dosage 0 1 - Drug Product Composition: FML

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    FML

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    $ API Ref.Price (USD/KG) : 8,519Xls

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    USFDA APPLICATION NUMBER - 16851 / DOSAGE - SUSPENSION/DROPS;OPHTHALMIC - 0.1%

    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    FLUOROMETHOLONE(UNII: SV0CSG527L)
    (FLUOROMETHOLONE - UNII:SV0CSG527L)     		FLUOROMETHOLONE1mg in 1

    Inactive Ingredients

    Ingredient Name
    REMEDYREPACK INC.
    BENZALKONIUM CHLORIDE(F5UM2KM3W7)
    EDETATE DISODIUM(7FLD91C86K)
    POLYSORBATE 80(6OZP39ZG8H)
    POLYVINYL ALCOHOL, UNSPECIFIED(532B59J990)
    SODIUM CHLORIDE(451W47IQ8X)
    SODIUM HYDROXIDE(55X04QC32I)
    SODIUM PHOSPHATE, DIBASIC(GR686LBA74)
    SODIUM PHOSPHATE, MONOBASIC(3980JIH2SW)
    WATER(059QF0KO0R)