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    Setid 77dd7fb3 18c4 4acb Af07 F929dff03903 Applno 13295 Form Injectable Injection Dosage 60 - Drug Product Composition: Iothalamate Meglumine

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    Iothalamate Meglumine

    FINISHED DOSAGE FORMULATIONS

    DRUG PRODUCT COMPOSITIONS

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    USFDA APPLICATION NUMBER - 13295 / DOSAGE - INJECTABLE;INJECTION - 60%

    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    IOTHALAMATE MEGLUMINE(UNII: XUW72GOP7W)
    (IOTHALAMIC ACID - UNII:16CHD79MIX)     		IOTHALAMATE MEGLUMINE430mg in 1

    Inactive Ingredients

    Ingredient Name
    Liebel-Flarsheim Company LLC
    EDETATE CALCIUM DISODIUM(25IH6R4SGF)
    SODIUM PHOSPHATE, MONOBASIC, UNSPECIFIED FORM(3980JIH2SW)