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Setid 95976f1d 1b36 4f08 A98f 36d5d7883d7b Applno 20796 Form Tablet Oral Dosage 200mg - Drug Product Composition: (E)-2-cyano-3-(3,4-dihydroxy-5-nitrophenyl)-N,N-diethylprop-2-enamide

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$ API Ref.Price (USD/KG) : 216Xls

USFDA APPLICATION NUMBER - 20796 / DOSAGE - TABLET;ORAL - 200MG

Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ENTACAPONE(UNII: 4975G9NM6T)
(ENTACAPONE - UNII:4975G9NM6T)
ENTACAPONE200mg

Inactive Ingredients

Ingredient Name
Avera McKennan Hospital
AvKARE, Inc.
Cardinal Health
KAISER FOUNDATION HOSPITALS
Sun Pharma Global FZE
Major Pharmaceuticals
Mylan Institutional Inc.
Mylan Pharmaceuticals Inc.
Novartis Pharmaceuticals Corporation
Sunshine Lake Pharma Co., Ltd.
CELLULOSE, MICROCRYSTALLINE(OP1R32D61U)     
CROSCARMELLOSE SODIUM(M28OL1HH48) 
FERRIC OXIDE RED(1K09F3G675)
FERRIC OXIDE YELLOW(EX438O2MRT)
GLYCERIN(PDC6A3C0OX) 
HYDROGENATED COTTONSEED OIL(Z82Y2C65EA)   
HYDROXYPROPYL CELLULOSE(RFW2ET671P)         
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)
MANNITOL(3OWL53L36A)
MICROCRYSTALLINE CELLULOSE(OP1R32D61U)     
POLYETHYLENE GLYCOL 4000(4R4HFI6D95)         
POLYSORBATE 80(6OZP39ZG8H) 
POLYVINYL ALCOHOL, UNSPECIFIED(532B59J990)         
POVIDONE, UNSPECIFIED(FZ989GH94E)         
SODIUM STARCH GLYCOLATE TYPE A POTATO(5856J3G2A2)        
SODIUM STARCH GLYCOLATE TYPE B POTATO(27NA468985)         
SUCROSE(C151H8M554)  
TALC(7SEV7J4R1U)         
TITANIUM DIOXIDE(15FIX9V2JP)