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Drug Product Composition: Prestwick3_000052

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$ API Ref.Price (USD/KG) : 137Xls

USFDA APPLICATION NUMBER - 20234 / DOSAGE - TABLET, EXTENDED RELEASE;ORAL - 400MG

Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CARBAMAZEPINE(UNII: 33CM23913M)
(CARBAMAZEPINE - UNII:33CM23913M)
CARBAMAZEPINE200mg

Inactive Ingredients

Ingredient Name
American Health Packaging
Avera McKennan Hospital
REMEDYREPACK INC.
KAISER FOUNDATION HOSPITALS
Cardinal Health
REMEDYREPACK INC.
AMMONIO METHACRYLATE COPOLYMER TYPE A(8GQS4E66YY)     
CELLULOSE, MICROCRYSTALLINE(OP1R32D61U)    
DEXTRATES(G263MI44RU)  
diethyl phthalate(UF064M00AF)  
FERROSOFERRIC OXIDE(XM0M87F357)     
LACTOSE MONOHYDRATE(EWQ57Q8I5X)  
MAGNESIUM STEARATE(70097M6I30) 
MANNITOL(3OWL53L36A)  
MICROCRYSTALLINE CELLULOSE(OP1R32D61U)   
POLYETHYLENE GLYCOL(3WJQ0SDW1A)     
POLYETHYLENE GLYCOL, UNSPECIFIED(3WJQ0SDW1A)    
POLYETHYLENE GLYCOLS(3WJQ0SDW1A)    
POWDERED CELLULOSE(SMD1X3XO9M)     
SODIUM LAURYL SULFATE(368GB5141J)  
SODIUM STARCH GLYCOLATE TYPE A POTATO(5856J3G2A2)  
starch, corn(O8232NY3SJ)  
TITANIUM DIOXIDE(15FIX9V2JP)