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    Setid 010f9162 9f7f 4b6d A6e4 4f832f26f38e Applno 21208 Form Tablet Orally Disintegrating Oral Dosage 45mg - Drug Product Composition: Mirtabene

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    Mirtabene

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    $ API Ref.Price (USD/KG) : 374Xls

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    USFDA APPLICATION NUMBER - 21208 / DOSAGE - TABLET, ORALLY DISINTEGRATING;ORAL - 45MG

    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    MIRTAZAPINE(UNII: A051Q2099Q)
    (MIRTAZAPINE - UNII:A051Q2099Q)     		MIRTAZAPINE45mg | 30mg | 15mg | 30mg | 15mg | 15mg | 30mg | 45mg

    Inactive Ingredients

    Ingredient Name
    Cadila Healthcare Limited
    Viona Pharmaceuticals Inc.
    Zydus Pharmaceuticals (USA) Inc.
    Actavis Pharma, Inc.
    Amneal Pharmaceuticals of New York LLC
    Bryant Ranch Prepack
    Organon USA Inc.
    Prasco Laboratories
    Teva Pharmaceuticals USA, Inc.
    ALPHA-TOCOPHEROL(H4N855PNZ1)      
    ANHYDROUS CITRIC ACID(XF417D3PSL)      
    ASPARTAME(Z0H242BBR1)
    CASSAVA(MAO53YB5PV)        
    CELLULOSE, MICROCRYSTALLINE(OP1R32D61U)     
    CITRIC ACID MONOHYDRATE(2968PHW8QP)       
    CROSPOVIDONE (15 MPA.S AT 5%)(68401960MK)        
    CROSPOVIDONE(2S7830E561)      
    crospovidone(68401960MK)       
    CROSPOVIDONE, UNSPECIFIED(2S7830E561)     
    DEXTRIN PALMITATE (CORN; 20000 MW)(89B2BSF9I3)        
    DIMETHYLAMINOETHYL METHACRYLATE - BUTYL METHACRYLATE - METHYL METHACRYLATE COPOLYMER(905HNO1SIH)        
    FD&C YELLOW NO. 6(H77VEI93A8)        
    FERRIC OXIDE RED(1K09F3G675)        
    FERRIC OXIDE YELLOW(EX438O2MRT)        
    HYDROXYPROPYL CELLULOSE (1600000 WAMW)(RFW2ET671P)        
    HYPROMELLOSE, UNSPECIFIED(3NXW29V3WO)        
    hypromelloses(3NXW29V3WO)        
    LACTOSE, UNSPECIFIED FORM(J2B2A4N98G)        
    MAGNESIUM STEARATE(70097M6I30)
    MALTODEXTRIN(7CVR7L4A2D)      
    MANNITOL(3OWL53L36A)
    MICROCRYSTALLINE CELLULOSE(OP1R32D61U)    
    ORANGE JUICE(5A9KE2L9L3)        
    ORANGE OIL(AKN3KSD11B)        
    POLYETHYLENE GLYCOL 8000(Q662QK8M3B)        
    POVIDONE K30(U725QWY32X)      
    POVIDONE, UNSPECIFIED(FZ989GH94E)        
    povidones(FZ989GH94E)        
    SILICON DIOXIDE(ETJ7Z6XBU4) 
    sodium bicarbonate(8MDF5V39QO)       
    SODIUM STEARYL FUMARATE(7CV7WJK4UI)   
    STARCH, CORN(O8232NY3SJ)       
    SUCROSE(C151H8M554)       
    TITANIUM DIOXIDE(15FIX9V2JP)        
    XYLITOL(VCQ006KQ1E)