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    Drug Product Composition: 03375_FLUKA

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    03375_FLUKA

    ACTIVE PHARMA INGREDIENTS

    DEVELOPMENTS

    FINISHED DOSAGE FORMULATIONS

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    USFDA APPLICATION NUMBER - 16682 / DOSAGE - INJECTABLE;INJECTION - 20MG/100ML;30MG/100ML;600MG/100ML;310MG/100ML

    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    CALCIUM CHLORIDE(UNII: M4I0D6VV5M)
    (CALCIUM CATION - UNII:2M83C4R6ZB)     		CALCIUM CHLORIDE20mg in 100
    POTASSIUM CHLORIDE(UNII: 660YQ98I10)
    (POTASSIUM CATION - UNII:295O53K152)     		POTASSIUM CHLORIDE30mg in 100
    SODIUM CHLORIDE(UNII: 451W47IQ8X)
    (CHLORIDE ION - UNII:Q32ZN48698)     		SODIUM CHLORIDE600mg in 100
    SODIUM LACTATE(UNII: TU7HW0W0QT)
    (LACTIC ACID - UNII:33X04XA5AT)     		SODIUM LACTATE310mg in 100

    Inactive Ingredients

    Ingredient Name
    Hospira, Inc.
    B. Braun Medical Inc.
    Baxter Healthcare Corporation
    REMEDYREPACK INC.
    HYDROCHLORIC ACID(QTT17582CB)   
    SODIUM HYDROXIDE(55X04QC32I)   
    WATER(059QF0KO0R)