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    Setid 7881c39e 0624 4c14 A6c3 7a9dc81c198c Applno 21086 Form Tablet Orally Disintegrating Oral Dosage 5mg - Drug Product Composition: Symbyax

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    Symbyax

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    $ API Ref.Price (USD/KG) : 827Xls

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    USFDA APPLICATION NUMBER - 21086 / DOSAGE - TABLET, ORALLY DISINTEGRATING;ORAL - 5MG

    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    Olanzapine(UNII: N7U69T4SZR)
    (Olanzapine - UNII:N7U69T4SZR)     		Olanzapine10mg | 5mg | 10mg | 5mg | 2.5mg

    Inactive Ingredients

    Ingredient Name
    Cardinal Health
    Sun Pharmaceutical Industries Limited
    A-S Medication Solutions
    Ajanta Pharma Limited
    American Health Packaging
    Avera McKennan Hospital
    Bryant Ranch Prepack
    Dr.Reddy's Laboratories Limited
    Prasco Laboratories
    REMEDYREPACK INC.
    Sunshine Lake Pharma Co., Ltd.
    Torrent Pharmaceuticals Limited
    Elanco Animal Health Co
    AMMONIUM LAURETH-5 SULFATE(43ZIH89I48)            
    ANHYDROUS LACTOSE(3SY5LH9PMK)            
    aspartame(Z0H242BBR1) 
    Benzyl Alcohol(LKG8494WBH)            
    CARBOXYMETHYLCELLULOSE CALCIUM(UTY7PDF93L)          
    Carnauba wax(R12CBM0EIZ)            
    CELLULOSE, MICROCRYSTALLINE(OP1R32D61U)    
    Cholesterol(97C5T2UQ7J)            
    Croscarmellose Sodium(M28OL1HH48)            
    CROSPOVIDONE (15 MPA.S AT 5%)(68401960MK)        
    CROSPOVIDONE(2S7830E561)          
    CROSPOVIDONE(68401960MK)      
    Ethylcelluloses(7Z8S9VYZ4B)            
    FD&C Blue No. 1(H3R47K3TBD)            
    GELATIN, UNSPECIFIED(2G86QN327L)            
    GUAR GUM(E89I1637KE)            
    HYDROXYPROPYL CELLULOSE (1200000 MW)(RFW2ET671P)            
    HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTED(2165RE0K14)         
    HYPROMELLOSE, UNSPECIFIED(3NXW29V3WO)            
    Isopropyl alcohol(ND2M416302)            
    LACTOSE, UNSPECIFIED FORM(J2B2A4N98G)            
    LOW-SUBSTITUTED HYDROXYPROPYL CELLULOSE, UNSPECIFIED(2165RE0K14)            
    MAGNESIUM STEARATE(70097M6I30)
    Maltodextrin(7CVR7L4A2D)            
    MANNITOL(3OWL53L36A)   
    Methylparaben Sodium(CR6K9C2NHK)            
    MICROCRYSTALLINE CELLULOSE(OP1R32D61U)        
    PINEAPPLE(2A88ZO081O)            
    POLACRILIN POTASSIUM(0BZ5A00FQU)            
    Polyethylene Glycol 8000(Q662QK8M3B)            
    POLYSORBATE 80(6OZP39ZG8H)            
    polyvinyl acetate(32K497ZK2U)            
    Povidone K29/32(390RMW2PEQ)            
    povidone(FZ989GH94E)            
    Propylene Glycol(6DC9Q167V3)            
    Propylparaben Sodium(625NNB0G9N)            
    SILICON DIOXIDE(ETJ7Z6XBU4)     
    sodium lauryl sulfate(368GB5141J)        
    SODIUM STEARYL FUMARATE(7CV7WJK4UI)         
    STARCH, CORN(O8232NY3SJ)          
    STRAWBERRY(4J2TY8Y81V)            
    SUCRALOSE(96K6UQ3ZD4)          
    Titanium dioxide(15FIX9V2JP)            
    Triethyl Citrate(8Z96QXD6UM)            
    XYLITOL(VCQ006KQ1E)