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Drug Product Composition: CID153941

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$ API Ref.Price (USD/KG) : 219,311Xls

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)