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    Setid 394000b0 F55b 49f7 A9cb 1c16b02a8e30 Applno 19599 Form Cream Topical Dosage 1 - Drug Product Composition: NAFTIFINE HCL

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    NAFTIFINE HCL

    ACTIVE PHARMA INGREDIENTS

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    FINISHED DOSAGE FORMULATIONS

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    PharmaCompass
    $ API Ref.Price (USD/KG) : 614Xls

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    USFDA APPLICATION NUMBER - 19599 / DOSAGE - CREAM;TOPICAL - 1% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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
    Naftifine Hydrochloride(UNII: 25UR9N9041)
    (Naftifine - UNII:4FB1TON47A)     		Naftifine Hydrochloride10mg in 2

    Inactive Ingredients

    Ingredient Name
    Merz Pharmaceuticals, LLC
    Renaissance Pharma, Inc.
    Sebela Pharmaceuticals Inc.
    BENZYL ALCOHOL(LKG8494WBH)
    cetyl alcohol(936JST6JCN)
    Cetyl Esters Wax(D072FFP9GU)
    HYDROCHLORIC ACID(QTT17582CB)
    ISOPROPYL MYRISTATE(0RE8K4LNJS)
    POLYSORBATE 60(CAL22UVI4M)
    SODIUM HYDROXIDE(55X04QC32I)
    Sorbitan Monostearate(NVZ4I0H58X)
    STEARYL ALCOHOL(2KR89I4H1Y)
    Water(059QF0KO0R)