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    Drug Product Composition: Opana ER

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    Opana ER

    ACTIVE PHARMA INGREDIENTS

    FINISHED DOSAGE FORMULATIONS

    DRUG PRODUCT COMPOSITIONS

    DIGITAL CONTENT

    GLOBAL SALES INFORMATION

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    USFDA APPLICATION NUMBER - 21611 / DOSAGE - TABLET;ORAL - 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    OXYMORPHONE HYDROCHLORIDE(UNII: 5Y2EI94NBC)
    (OXYMORPHONE - UNII:9VXA968E0C)     		OXYMORPHONE HYDROCHLORIDE5mg | 10mg

    Inactive Ingredients

    Ingredient Name
    American Health Packaging
    Endo Pharmaceuticals Inc.
    Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC
    Par Pharmaceutical
    Bryant Ranch Prepack
    D&C RED NO. 30(2S42T2808B) 
    FD&C BLUE NO. 2(L06K8R7DQK) 
    LACTOSE MONOHYDRATE(EWQ57Q8I5X)
    MAGNESIUM STEARATE(70097M6I30)
    STARCH, CORN(O8232NY3SJ)