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    Setid 14d98490 4f8f 4d2f A4e9 7a3d7a0199ba Applno 203414 Form Tablet Oral Dosage Eq 12 5mg Base 500mg - Drug Product Composition: OSENI

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    USFDA APPLICATION NUMBER - 203414 / DOSAGE - TABLET;ORAL - EQ 12.5MG BASE;500MG

    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    ALOGLIPTIN BENZOATE(UNII: EEN99869SC)
    (Alogliptin - UNII:JHC049LO86)     		Alogliptin12.5mg | 12.5mg
    Metformin hydrochloride(UNII: 786Z46389E)
    (Metformin - UNII:9100L32L2N)     		Metformin hydrochloride1000mg | 500mg

    Inactive Ingredients

    Ingredient Name
    Padagis Israel Pharmaceuticals Ltd
    CROSPOVIDONE, UNSPECIFIED(2S7830E561)
    ferric oxide yellow(EX438O2MRT)
    HYPROMELLOSE 2910 (6 MPA.S)(0WZ8WG20P6)
    magnesium stearate(70097M6I30)
    mannitol(3OWL53L36A)
    microcrystalline cellulose(OP1R32D61U)
    POVIDONE, UNSPECIFIED(FZ989GH94E)
    talc(7SEV7J4R1U)
    titanium dioxide(15FIX9V2JP)
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