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Drug Product Composition: Simvastatin

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

USFDA APPLICATION NUMBER - 19766 / DOSAGE - TABLET;ORAL - 80MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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
SIMVASTATIN(UNII: AGG2FN16EV)
(SIMVASTATIN - UNII:AGG2FN16EV)
SIMVASTATIN20mg

Inactive Ingredients

Ingredient Name
Lake Erie Medical DBA Quality Care Products LLC
Merck Sharp & Dohme Corp.
ASCORBIC ACID(PQ6CK8PD0R)
BUTYLATED HYDROXYANISOLE(REK4960K2U)
CELLULOSE, MICROCRYSTALLINE(OP1R32D61U) 
CITRIC ACID MONOHYDRATE(2968PHW8QP)
FERRIC OXIDE RED(1K09F3G675)
FERRIC OXIDE YELLOW(EX438O2MRT)
HYDROXYPROPYL CELLULOSE (1600000 WAMW)(RFW2ET671P) 
HYDROXYPROPYL CELLULOSE(RFW2ET671P) 
HYPROMELLOSE 2910 (6 MPA.S)(0WZ8WG20P6)
LACTOSE(J2B2A4N98G) 
LACTOSE, UNSPECIFIED FORM(J2B2A4N98G) 
MAGNESIUM STEARATE(70097M6I30)
MICROCRYSTALLINE CELLULOSE(OP1R32D61U) 
STARCH, CORN(O8232NY3SJ)
TALC(7SEV7J4R1U)
TITANIUM DIOXIDE(15FIX9V2JP)