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    Setid A0324a34 38f6 4edc B7d2 547abc0cb06c Applno 20279 Form Cream Topical Dosage 0 1 - Drug Product Composition: Prednicarbate

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    Prednicarbate

    ACTIVE PHARMA INGREDIENTS

    FINISHED DOSAGE FORMULATIONS

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    USFDA APPLICATION NUMBER - 20279 / DOSAGE - CREAM;TOPICAL - 0.1% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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
    Prednicarbate(UNII: V901LV1K7D)
    (Prednicarbate - UNII:V901LV1K7D)     		Prednicarbate1mg in 1

    Inactive Ingredients

    Ingredient Name
    Oceanside Pharmaceuticals
    Prasco Laboratories
    Valeant Pharmaceuticals North America LLC
    aluminum stearate(U6XF9NP8HM)
    cetostearyl alcohol(2DMT128M1S)
    edetate disodium(7FLD91C86K)
    isopropyl myristate(0RE8K4LNJS)
    lactic acid(33X04XA5AT) 
    LACTIC ACID, UNSPECIFIED FORM(33X04XA5AT)  
    lanolin alcohols(884C3FA9HE) 
    MAGNESIUM STEARATE(70097M6I30)  
    mineral oil(T5L8T28FGP)
    petrolatum(4T6H12BN9U)
    water(059QF0KO0R)