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    Drug Product Composition: Sulconazole Nitrate

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    Sulconazole Nitrate

    ACTIVE PHARMA INGREDIENTS

    FINISHED DOSAGE FORMULATIONS

    DRUG PRODUCT COMPOSITIONS

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    USFDA APPLICATION NUMBER - 18737 / DOSAGE - CREAM;TOPICAL - 1%

    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    SULCONAZOLE NITRATE(UNII: 1T89100D5U)
    (SULCONAZOLE - UNII:5D9HAA5Q5S)     		SULCONAZOLE NITRATE10mg in 1

    Inactive Ingredients

    Ingredient Name
    Sun Pharmaceutical Industries, Inc.
    ASCORBYL PALMITATE(QN83US2B0N)
    CETYL ALCOHOL(936JST6JCN)
    GLYCERYL MONOSTEARATE(230OU9XXE4)
    ISOPROPYL MYRISTATE(0RE8K4LNJS)
    NITRIC ACID(411VRN1TV4)
    PEG-100 STEARATE(YD01N1999R)
    POLYSORBATE 60(CAL22UVI4M)
    PROPYLENE GLYCOL(6DC9Q167V3)
    SODIUM HYDROXIDE(55X04QC32I)
    SORBITAN MONOSTEARATE(NVZ4I0H58X)
    STEARYL ALCOHOL(2KR89I4H1Y)
    WATER(059QF0KO0R)