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    Setid 92b37df9 4602 442f B8ef 32744f5f412b Applno 21797 Form Tablet Oral Dosage 0 5mg - Drug Product Composition: Entecavir

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    Entecavir

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    $ API Ref.Price (USD/KG) : 213,539Xls

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    USFDA APPLICATION NUMBER - 21797 / DOSAGE - TABLET;ORAL - 0.5MG

    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    entecavir(UNII: 5968Y6H45M)
    (entecavir anhydrous - UNII:NNU2O4609D)     		entecavir1.0mg | 0.5mg

    Inactive Ingredients

    Ingredient Name
    ACETRIS HEALTH, LLC
    AvKARE
    Cipla USA Inc.
    Golden State Medical Supply, Inc.
    NorthStar RxLLC
    Zydus Pharmaceuticals USA Inc.
    E.R. Squibb & Sons, L.L.C.
    Par Pharmaceutical, Inc.
    AvPAK
    Par Pharmaceutical Inc.
    BrightGene Bio-Medical Technology Co., Ltd.
    Florida Pharmaceutical Products, LLC
    Teva Pharmaceuticals USA, Inc.
    Sunshine Lake Pharma Co., Ltd.
    CELLULOSE, MICROCRYSTALLINE(OP1R32D61U)        
    CITRIC ACID MONOHYDRATE(2968PHW8QP)             
    CROSPOVIDONE (12 MPA.S AT 5%)(40UAA97IT9)            
    CROSPOVIDONE (15 MPA.S AT 5%)(68401960MK)         
    CROSPOVIDONE(2S7830E561)            
    CROSPOVIDONE(68401960MK)            
    CROSPOVIDONE, UNSPECIFIED(2S7830E561)           
    FD&C BLUE NO. 2--ALUMINUM LAKE(4AQJ3LG584)             
    FD&C RED NO. 40(WZB9127XOA)            
    FD&C YELLOW NO. 6(H77VEI93A8)             
    FERRIC OXIDE RED(1K09F3G675)      
    FERRIC OXIDE YELLOW(EX438O2MRT)           
    FERROSOFERRIC OXIDE(XM0M87F357)             
    HYPROMELLOSE 2910 (15 MPA.S)(36SFW2JZ0W)            
    HYPROMELLOSE 2910 (5 MPA.S)(R75537T0T4)             
    HYPROMELLOSE 2910 (6 MPA.S)(0WZ8WG20P6)          
    HYPROMELLOSE, UNSPECIFIED(3NXW29V3WO)          
    HYPROMELLOSES(3NXW29V3WO)          
    LACTOSE MONOHYDRATE(EWQ57Q8I5X)  
    LECITHIN, SOYBEAN(1DI56QDM62)             
    MAGNESIUM STEARATE(70097M6I30)
    MALTITOL(D65DG142WK)             
    MANNITOL(3OWL53L36A)             
    METHYLPARABEN(A2I8C7HI9T)             
    MICROCRYSTALLINE CELLULOSE(OP1R32D61U)      
    PEG-2 STEARATE(94YQ11Y95F)             
    POLYETHYLENE GLYCOL 3350(G2M7P15E5P)           
    POLYETHYLENE GLYCOL 400(B697894SGQ)        
    POLYETHYLENE GLYCOL 4000(4R4HFI6D95)             
    POLYETHYLENE GLYCOL 6000(30IQX730WE)            
    POLYETHYLENE GLYCOL 8000(Q662QK8M3B)             
    POLYETHYLENE GLYCOL(3WJQ0SDW1A)             
    POLYETHYLENE GLYCOL, UNSPECIFIED(3WJQ0SDW1A)            
    polysorbate 80(6OZP39ZG8H)           
    POLYVINYL ALCOHOL (100000 MW)(949E52Z6MY)             
    POLYVINYL ALCOHOL, UNSPECIFIED(532B59J990)           
    POVIDONE K30(U725QWY32X)             
    POVIDONE(FZ989GH94E)           
    POVIDONE, UNSPECIFIED(FZ989GH94E)            
    PROPYLPARABEN(Z8IX2SC1OH)             
    SILICON DIOXIDE(ETJ7Z6XBU4)             
    SODIUM CITRATE, UNSPECIFIED FORM(1Q73Q2JULR)             
    SODIUM STARCH GLYCOLATE TYPE A POTATO(5856J3G2A2)            
    STARCH, CORN(O8232NY3SJ)             
    STARCH, PREGELATINIZED CORN(O8232NY3SJ)             
    TALC(7SEV7J4R1U)         
    titanium dioxide(15FIX9V2JP)
    TRIACETIN(XHX3C3X673)