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    Drug Product Composition: Gadopentetate Dimeglumine

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    Gadopentetate Dimeglumine

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    USFDA APPLICATION NUMBER - 19596 / DOSAGE - INJECTABLE;INJECTION - 469.01MG/ML

    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    GADOPENTETATE DIMEGLUMINE(UNII: RH248G8V27)
    (GADOPENTETATE - UNII:V7OK6J19HQ)     		GADOPENTETATE DIMEGLUMINE469.0mg in 1

    Inactive Ingredients

    Ingredient Name
    Alvogen, Inc
    Bayer HealthCare Pharmaceuticals Inc.
    MEGLUMINE(6HG8UB2MUY)
    PENTETIC ACID(7A314HQM0I)
    WATER(059QF0KO0R)