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    Drug Product Composition: Codeine Sulfate

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    Codeine Sulfate

    ACTIVE PHARMA INGREDIENTS

    FINISHED DOSAGE FORMULATIONS

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    USFDA APPLICATION NUMBER - 22402 / DOSAGE - TABLET;ORAL - 15MG

    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    CODEINE SULFATE(UNII: 11QV9BS0CB)
    (CODEINE ANHYDROUS - UNII:UX6OWY2V7J)     		CODEINE SULFATE60mg | 30mg | 15mg

    Inactive Ingredients

    Ingredient Name
    West-Ward Pharmaceuticals Corp.
    Hikma Pharmaceuticals USA Inc.
    CELLULOSE, MICROCRYSTALLINE(OP1R32D61U) 
    MICROCRYSTALLINE CELLULOSE(OP1R32D61U) 
    SILICON DIOXIDE(ETJ7Z6XBU4)
    STARCH, CORN(O8232NY3SJ)
    STEARIC ACID(4ELV7Z65AP)