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Drug Product Composition: Sertraline

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$ API Ref.Price (USD/KG) : 127Xls

USFDA APPLICATION NUMBER - 19839 / DOSAGE - TABLET;ORAL - EQ 200MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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
sertraline hydrochloride(UNII: UTI8907Y6X)
(sertraline - UNII:QUC7NX6WMB)
sertraline hydrochloride100mg

Inactive Ingredients

Ingredient Name
REMEDYREPACK INC.
Aphena Pharma Solutions - Tennessee, LLC
Bryant Ranch Prepack
Cardinal Health
KAISER FOUNDATION HOSPITALS
Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC
PD-Rx Pharmaceuticals, Inc.
ALCOHOL, X-RAY EXPOSED (1000 RAD)(6PRJ93602P)      
ALUMINUM OXIDE(LMI26O6933)
AMMONIUM LAURETH-5 SULFATE(43ZIH89I48)      
BUTYLATED HYDROXYTOLUENE(1P9D0Z171K)      
CALCIUM PHOSPHATE, DIBASIC, DIHYDRATE(O7TSZ97GEP)     
cellulose, microcrystalline(OP1R32D61U)  
D&C YELLOW NO. 10(35SW5USQ3G)   
DIBASIC CALCIUM PHOSPHATE DIHYDRATE(O7TSZ97GEP) 
FD&C BLUE NO. 1(H3R47K3TBD)   
FD&C BLUE NO. 2(L06K8R7DQK) 
FD&C RED NO. 40(WZB9127XOA)   
FERRIC OXIDE YELLOW(EX438O2MRT)  
GLYCERIN(PDC6A3C0OX)      
HYDROXYPROPYL CELLULOSE (1200000 MW)(RFW2ET671P)     
Hydroxypropyl Cellulose (1600000 WAMW)(RFW2ET671P)    
HYDROXYPROPYL CELLULOSE (TYPE H)(RFW2ET671P)     
hydroxypropyl cellulose(RFW2ET671P)    
hypromellose(3NXW29V3WO)      
HYPROMELLOSE, UNSPECIFIED(3NXW29V3WO)   
HYPROMELLOSES(3NXW29V3WO)   
MAGNESIUM STEARATE(70097M6I30)
MENTHOL 1-PROPYLENE GLYCOL CARBONATE, (-)-(2WL8FX4EEZ)      
MICROCRYSTALLINE CELLULOSE(OP1R32D61U)   
polyethylene glycol(3WJQ0SDW1A)     
POLYETHYLENE GLYCOL, UNSPECIFIED(3WJQ0SDW1A)   
POLYETHYLENE GLYCOLS(3WJQ0SDW1A)   
polysorbate 80(6OZP39ZG8H)
titanium dioxide(15FIX9V2JP)