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Drug Product Composition: Simvastatin

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$ API Ref.Price (USD/KG) : 225Xls

USFDA APPLICATION NUMBER - 21687 / DOSAGE - TABLET;ORAL - 10MG;40MG

Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
EZETIMIBE(UNII: EOR26LQQ24)
(EZETIMIBE - UNII:EOR26LQQ24)
EZETIMIBE10mg
SIMVASTATIN(UNII: AGG2FN16EV)
(SIMVASTATIN - UNII:AGG2FN16EV)
SIMVASTATIN20mg

Inactive Ingredients

Ingredient Name
A-S Medication Solutions
Impax Generics
ANI Pharmaceuticals, Inc.
AvKARE
Lake Erie Medical DBA Quality Care Products LLC
Merck Sharp & Dohme Corp.
PD-Rx Pharmaceuticals, Inc.
REMEDYREPACK INC.
ANHYDROUS CITRIC ACID(XF417D3PSL)      
ASCORBIC ACID(PQ6CK8PD0R)      
BUTYLATED HYDROXYANISOLE(REK4960K2U)
CELLULOSE, MICROCRYSTALLINE(OP1R32D61U)    
CITRIC ACID MONOHYDRATE(2968PHW8QP)  
CROSCARMELLOSE SODIUM(M28OL1HH48)
FD&C BLUE NO. 2(L06K8R7DQK)       
FD&C RED NO. 40(WZB9127XOA)       
FERRIC OXIDE RED(1K09F3G675)      
FERRIC OXIDE YELLOW(EX438O2MRT)      
FERROSOFERRIC OXIDE(XM0M87F357)       
HYPROMELLOSE 2910 (5 MPA.S)(R75537T0T4)       
HYPROMELLOSE 2910 (6 MPA.S)(0WZ8WG20P6)       
HYPROMELLOSE, UNSPECIFIED(3NXW29V3WO)    
HYPROMELLOSES(3NXW29V3WO)      
ISOPROPYL ALCOHOL(ND2M416302)       
LACTOSE MONOHYDRATE(EWQ57Q8I5X)
MAGNESIUM STEARATE(70097M6I30)
MICROCRYSTALLINE CELLULOSE(OP1R32D61U)    
POLYETHYLENE GLYCOL 3350(G2M7P15E5P)       
PROPYL GALLATE(8D4SNN7V92) 
SODIUM LAURYL SULFATE(368GB5141J)       
STARCH, CORN(O8232NY3SJ)       
TALC(7SEV7J4R1U)       
TITANIUM DIOXIDE(15FIX9V2JP)       
WATER(059QF0KO0R)