loader
Please Wait
Applying Filters...
menu
    • menu

    Setid 010f9162 9f7f 4b6d A6e4 4f832f26f38e Applno 21208 Form Tablet Orally Disintegrating Oral Dosage 15mg - Drug Product Composition: Mirtabene

    Menu

    Mirtabene

    ACTIVE PHARMA INGREDIENTS

    DEVELOPMENTS

    INTERMEDIATES

    FINISHED DOSAGE FORMULATIONS

    DRUG PRODUCT COMPOSITIONS

    RELATED EXCIPIENT COMPANIES

    EXCIPIENTS BY APPLICATIONS

    DIGITAL CONTENT

    GLOBAL SALES INFORMATION

    MARKET PLACE

    PATENTS & EXCLUSIVITIES

    REF. STANDARDS & IMPURITIES

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

    Filters

    clear-filterReset all filters
    SearchXls

    USFDA APPLICATION NUMBER - 21208 / DOSAGE - TABLET, ORALLY DISINTEGRATING;ORAL - 15MG

    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)