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    Setid Ed3ef3f8 8cb7 40db 9d75 E728ee607760 Applno 206500 Form Tablet Oral Dosage Eq 90mg Base - Drug Product Composition: Rolapitant

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    Rolapitant

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    USFDA APPLICATION NUMBER - 206500 / DOSAGE - TABLET;ORAL - EQ 90MG BASE

    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    ROLAPITANT HYDROCHLORIDE(UNII: 57O5S1QSAQ)
    (rolapitant - UNII:NLE429IZUC)     		rolapitant90mg
    rolapitant(UNII: NLE429IZUC)
    (rolapitant - UNII:NLE429IZUC)     		rolapitant1.8mg in 1

    Inactive Ingredients

    Ingredient Name
    Tesaro, Inc.
    croscarmellose sodium(M28OL1HH48)
    FD&C Blue NO. 2(L06K8R7DQK)
    hydrochloric acid(QTT17582CB)
    lactose monohydrate(EWQ57Q8I5X)
    magnesium stearate(70097M6I30)
    medium-chain triglycerides(C9H2L21V7U)
    microcrystalline cellulose(OP1R32D61U)
    peg-15 hydroxystearates(71YMM1X75O)
    polyethylene glycol, unspecified(3WJQ0SDW1A)
    polysorbate 80(6OZP39ZG8H)
    polyvinyl alcohol, unspecified(532B59J990)
    povidone, unspecified(FZ989GH94E)
    silicon dioxide(ETJ7Z6XBU4)
    sodium chloride(451W47IQ8X)
    sodium hydroxide(55X04QC32I)
    sodium phosphate, dibasic, anhydrous(22ADO53M6F)
    soybean oil(241ATL177A)
    starch, corn(O8232NY3SJ)
    talc(7SEV7J4R1U)
    titanium dioxide(15FIX9V2JP)
    water(059QF0KO0R)