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Drug Product Composition: Prestwick3_000052

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

USFDA APPLICATION NUMBER - 20712 / DOSAGE - CAPSULE, EXTENDED RELEASE;ORAL - 300MG

Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CARBAMAZEPINE(UNII: 33CM23913M)
(CARBAMAZEPINE - UNII:33CM23913M)
CARBAMAZEPINE300mg

Inactive Ingredients

Ingredient Name
Golden State Medical Supply, Inc.
Nostrum Laboratories, Inc.
REMEDYREPACK INC.
Teva Pharmaceuticals USA Inc
Avera McKennan Hospital
ALUMINUM OXIDE(LMI26O6933) 
AMMONIO METHACRYLATE COPOLYMER TYPE A(8GQS4E66YY)    
CARNAUBA WAX(R12CBM0EIZ)    
CELLULOSE, MICROCRYSTALLINE(OP1R32D61U) 
CITRIC ACID MONOHYDRATE(2968PHW8QP)   
D&C RED NO. 28(767IP0Y5NH)   
D&C YELLOW NO. 10(35SW5USQ3G) 
ETHYLCELLULOSE (20 MPA.S)(BJG0S321QY)  
FD&C BLUE NO. 1(H3R47K3TBD) 
FD&C BLUE NO. 2(L06K8R7DQK)
FD&C GREEN NO. 3(3P3ONR6O1S)    
FD&C RED NO. 40(WZB9127XOA) 
FD&C YELLOW NO. 6(H77VEI93A8) 
FERRIC OXIDE RED(1K09F3G675)   
FERRIC OXIDE YELLOW(EX438O2MRT)   
FERROSOFERRIC OXIDE(XM0M87F357)  
GELATIN(2G86QN327L)
GELATIN, UNSPECIFIED(2G86QN327L)    
HYPROMELLOSE 2910 (6 MPA.S)(0WZ8WG20P6)  
HYPROMELLOSE, UNSPECIFIED(3NXW29V3WO)    
INDIGOTINDISULFONATE SODIUM(D3741U8K7L)    
LACTOSE MONOHYDRATE(EWQ57Q8I5X)  
MEDIUM-CHAIN TRIGLYCERIDES(C9H2L21V7U)  
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE A(NX76LV5T8J)    
MICROCRYSTALLINE CELLULOSE(OP1R32D61U)    
OLEIC ACID(2UMI9U37CP)  
POLYETHYLENE GLYCOL 1450(OJ4Z5Z32L4)    
POLYETHYLENE GLYCOL 4500(TVH7653921)    
POLYETHYLENE GLYCOL, UNSPECIFIED(3WJQ0SDW1A)   
POLYETHYLENE GLYCOLS(3WJQ0SDW1A) 
POVIDONE(FZ989GH94E)    
POVIDONE, UNSPECIFIED(FZ989GH94E)    
POVIDONES(FZ989GH94E)    
PROPYLENE GLYCOL(6DC9Q167V3)   
SHELLAC(46N107B71O)  
SILICON DIOXIDE(ETJ7Z6XBU4) 
SODIUM HYDROXIDE(55X04QC32I)    
SODIUM LAURYL SULFATE(368GB5141J)
SORBITAN MONOLAURATE(6W9PS8B71J)    
TALC(7SEV7J4R1U)   
TITANIUM DIOXIDE(15FIX9V2JP)
TRIETHYL CITRATE(8Z96QXD6UM)