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    Setid 7b57509a 3d5d 41d4 8fed 1471e26372a3 Applno 204819 Form Tablet Oral Dosage 2mg - Drug Product Composition: Adempas

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    Adempas

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    USFDA APPLICATION NUMBER - 204819 / DOSAGE - TABLET;ORAL - 2MG

    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    RIOCIGUAT(UNII: RU3FE2Y4XI)
    (RIOCIGUAT - UNII:RU3FE2Y4XI)     		RIOCIGUAT0.5mg | 1mg | 1.5mg | 2mg | 2.5mg

    Inactive Ingredients

    Ingredient Name
    Bayer HealthCare Pharmaceuticals Inc.
    CROSPOVIDONE (120 .MU.M)(68401960MK)
    FERRIC OXIDE RED(1K09F3G675)
    FERRIC OXIDE YELLOW(EX438O2MRT)
    HYDROXYPROPYL CELLULOSE (1600000 WAMW)(RFW2ET671P)
    HYPROMELLOSE, UNSPECIFIED(3NXW29V3WO)
    LACTOSE MONOHYDRATE(EWQ57Q8I5X)
    MAGNESIUM STEARATE(70097M6I30)
    MICROCRYSTALLINE CELLULOSE(OP1R32D61U)
    PROPYLENE GLYCOL(6DC9Q167V3)
    SODIUM LAURYL SULFATE(368GB5141J)
    TITANIUM DIOXIDE(15FIX9V2JP)
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