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Drug Product Composition: Prestwick3_000958

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$ API Ref.Price (USD/KG) : 317Xls

USFDA APPLICATION NUMBER - 20675 / DOSAGE - TABLET;ORAL - 500MG

Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ursodiol(UNII: 724L30Y2QR)
(ursodiol - UNII:724L30Y2QR)
ursodiol250mg | 500mg

Inactive Ingredients

Ingredient Name
Cardinal Health
Actavis Pharma, Inc.
American Health Packaging
Avera McKennan Hospital
BluePoint Laboratories
Impax Generics
Lake Erie Medical DBA Quality Care Products LLC
Strides Pharma Science Limited
CARNAUBA WAX(R12CBM0EIZ)       
CELLULOSE, MICROCRYSTALLINE(OP1R32D61U)
cetyl alcohol(936JST6JCN)       
COPOVIDONE K25-31(D9C330MD8B)       
dibutyl sebacate(4W5IH7FLNY)       
ETHYLCELLULOSES(7Z8S9VYZ4B)       
hydrogen peroxide(BBX060AN9V)       
HYPROMELLOSE 2910 (15000 MPA.S)(288VBX44JC)       
HYPROMELLOSE 2910 (6 MPA.S)(0WZ8WG20P6)       
HYPROMELLOSE, UNSPECIFIED(3NXW29V3WO)      
HYPROMELLOSES(3NXW29V3WO)  
LACTOSE MONOHYDRATE(EWQ57Q8I5X)   
MAGNESIUM STEARATE(70097M6I30)
MEDIUM-CHAIN TRIGLYCERIDES(C9H2L21V7U)       
MICROCRYSTALLINE CELLULOSE(OP1R32D61U)      
POLYDEXTROSE(VH2XOU12IE)       
polyethylene glycol 3350(G2M7P15E5P)     
POLYETHYLENE GLYCOL 400(B697894SGQ)  
POLYETHYLENE GLYCOL 8000(Q662QK8M3B)      
POLYETHYLENE GLYCOLS(3WJQ0SDW1A)       
POVIDONE K29/32(390RMW2PEQ)       
POVIDONE K30(U725QWY32X)       
POVIDONE(FZ989GH94E)      
POVIDONE, UNSPECIFIED(FZ989GH94E)      
POVIDONES(FZ989GH94E)    
SILICON DIOXIDE(ETJ7Z6XBU4)   
SODIUM LAURYL SULFATE(368GB5141J)      
SODIUM STARCH GLYCOLATE TYPE A POTATO(5856J3G2A2)
TITANIUM DIOXIDE(15FIX9V2JP)  
TROMETHAMINE(023C2WHX2V)