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Drug Product Composition: Quetiapine Hemifumarate

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$ API Ref.Price (USD/KG) : 121Xls

USFDA APPLICATION NUMBER - 20639 / DOSAGE - TABLET;ORAL - EQ 150MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
QUETIAPINE FUMARATE(UNII: 2S3PL1B6UJ)
(QUETIAPINE - UNII:BGL0JSY5SI)
QUETIAPINE FUMARATE200mg

Inactive Ingredients

Ingredient Name
Cardinal Health
Bryant Ranch Prepack
REMEDYREPACK INC.
Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC
Lake Erie Medical DBA Quality Care Products LLC
PD-Rx Pharmaceuticals, Inc.
AMMONIUM LAURETH-5 SULFATE(43ZIH89I48)     
CALCIUM PHOSPHATE, DIBASIC, DIHYDRATE(O7TSZ97GEP)   
CELLULOSE, MICROCRYSTALLINE(OP1R32D61U) 
DIBASIC CALCIUM PHOSPHATE DIHYDRATE(O7TSZ97GEP)  
FERRIC OXIDE RED(1K09F3G675)  
FERRIC OXIDE YELLOW(EX438O2MRT) 
HYPROMELLOSE(3NXW29V3WO)     
HYPROMELLOSE, UNSPECIFIED(3NXW29V3WO)    
HYPROMELLOSES(3NXW29V3WO) 
LACTOSE MONOHYDRATE(EWQ57Q8I5X)
MAGNESIUM STEARATE(70097M6I30)
MICROCRYSTALLINE CELLULOSE(OP1R32D61U)    
POLYETHYLENE GLYCOL(3WJQ0SDW1A)    
POLYETHYLENE GLYCOL, UNSPECIFIED(3WJQ0SDW1A)    
POLYETHYLENE GLYCOLS(3WJQ0SDW1A)    
POVIDONE(FZ989GH94E)   
POVIDONE, UNSPECIFIED(FZ989GH94E)    
POVIDONES(FZ989GH94E)   
SODIUM STARCH GLYCOLATE TYPE A POTATO(5856J3G2A2)
TITANIUM DIOXIDE(15FIX9V2JP)
WATER(059QF0KO0R)