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    Setid C94644d3 7b64 4f3d A0c7 12c77466a0fc Applno 19700 Form Solution Drops Ophthalmic Dosage 0 5 - Drug Product Composition: Ketorolac

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    Ketorolac

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    USFDA APPLICATION NUMBER - 19700 / DOSAGE - SOLUTION/DROPS;OPHTHALMIC - 0.5%

    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    KETOROLAC TROMETHAMINE(UNII: 4EVE5946BQ)
    (KETOROLAC - UNII:YZI5105V0L)     		KETOROLAC TROMETHAMINE5mg in 1

    Inactive Ingredients

    Ingredient Name
    A-S Medication Solutions
    Allergan, Inc.
    Direct Rx
    Lake Erie Medical DBA Quality Care Products LLC
    Micro Labs Limited
    Preferred Pharmaceuticals Inc.
    Preferred Pharmaceuticals, Inc.
    Proficient Rx LP
    REMEDYREPACK INC.
    Sun Pharma Global Inc.
    Unit Dose Services
    NuCare Pharmaceuticals,Inc.
    BENZALKONIUM CHLORIDE(F5UM2KM3W7) 
    edetate disodium(7FLD91C86K)
    hydrochloric acid(QTT17582CB)
    OCTOXYNOL-40(9T1C662FKS) 
    sodium chloride(451W47IQ8X)
    SODIUM HYDROXIDE(55X04QC32I) 
    WATER(059QF0KO0R)
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