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    Setid Eeba2959 9b95 4bd1 87af 00ed8c3976e8 Applno 20975 Form Injectable Injection Dosage 16 545gm 50ml 330 9mg Ml - Drug Product Composition: Gadoversetamide

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    Gadoversetamide

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    USFDA APPLICATION NUMBER - 20975 / DOSAGE - INJECTABLE;INJECTION - 16.545GM/50ML (330.9MG/ML)

    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    GADOVERSETAMIDE(UNII: RLM74T3Z9D)
    (GADOLINIUM CATION (3+) - UNII:AZV954TZ9N)     		GADOVERSETAMIDE0.5mmol in 1

    Inactive Ingredients

    Ingredient Name
    Liebel-Flarsheim Company LLC
    CALCIUM CHLORIDE(M4I0D6VV5M)
    CALCIUM VERSETAMIDE SODIUM(T8281IVO8L)
    HYDROCHLORIC ACID(QTT17582CB)
    SODIUM HYDROXIDE(55X04QC32I)
    WATER(059QF0KO0R)