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    Setid 05e6330b 6569 436e 9caf E86916460931 Applno 17922 Form Solution Nasal Dosage 0 01 - Drug Product Composition: Presinex

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    Presinex

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    USFDA APPLICATION NUMBER - 17922 / DOSAGE - SOLUTION;NASAL - 0.01%

    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    desmopressin acetate(UNII: XB13HYU18U)
    (desmopressin - UNII:ENR1LLB0FP)     		desmopressin0.1mg in 1

    Inactive Ingredients

    Ingredient Name
    Amring Pharmaceuticals, Inc.
    Ferring Pharmaceuticals Inc.
    sanofi-aventis U.S. LLC
    Benzalkonium chloride(F5UM2KM3W7)
    Chlorobutanol(HM4YQM8WRC) 
    Citric Acid Monohydrate(2968PHW8QP)
    HYDROCHLORIC ACID(QTT17582CB) 
    Sodium Chloride(451W47IQ8X)
    sodium phosphate, dibasic, dihydrate(94255I6E2T)