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    Setid D669ff68 Ddcf 42f6 913c D8f1aedbd9c4 Applno 22260 Form Injectable Injection Dosage Eq 0 5mg Base Vial - Drug Product Composition: Epoprostenol

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    Epoprostenol

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    USFDA APPLICATION NUMBER - 22260 / DOSAGE - INJECTABLE;INJECTION - EQ 0.5MG BASE/VIAL

    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    epoprostenol sodium(UNII: 4K04IQ1OF4)
    (epoprostenol - UNII:DCR9Z582X0)     		epoprostenol sodium15000ng in 10

    Inactive Ingredients

    Ingredient Name
    Actelion Pharmaceuticals US, Inc.
    Jubilant HollisterStier General Partnership
    Sun Pharmaceutical Industries, Inc.
    Teva Parenteral Medicines, Inc.
    arginine(94ZLA3W45F)  
    GLYCINE(TE7660XO1C)  
    MANNITOL(3OWL53L36A)  
    SODIUM CHLORIDE(451W47IQ8X)   
    SODIUM HYDROXIDE(55X04QC32I)
    SUCROSE(C151H8M554)