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Drug Product Composition: Fenofibric Acid

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$ API Ref.Price (USD/KG) : 84Xls

USFDA APPLICATION NUMBER - 21612 / DOSAGE - CAPSULE;ORAL - 150MG

Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
FENOFIBRATE(UNII: U202363UOS)
(FENOFIBRATE - UNII:U202363UOS)
FENOFIBRATE150mg | 50mg

Inactive Ingredients

Ingredient Name
H2-Pharma, LLC
Kowa Pharmaceuticals America, Inc.
D&C YELLOW NO. 10(35SW5USQ3G)
FD&C BLUE NO. 1(H3R47K3TBD)
FD&C BLUE NO. 2(L06K8R7DQK)
FD&C RED NO. 40(WZB9127XOA)
FERROSOFERRIC OXIDE(XM0M87F357)
GELATIN(2G86QN327L) 
GELATIN, UNSPECIFIED(2G86QN327L) 
HYDROXYPROPYL CELLULOSE (160000 WAMW)(0A7M0N7SPE) 
HYDROXYPROPYL CELLULOSE(RFW2ET671P) 
LAUROYL PEG-32 GLYCERIDES(H5ZC52369M) 
POLYETHYLENE GLYCOL 20000(5WKN5KL2O8) 
POLYETHYLENE GLYCOL 8000(Q662QK8M3B)
PROPYLENE GLYCOL(6DC9Q167V3)
SHELLAC(46N107B71O)
SODIUM STARCH GLYCOLATE TYPE A(H8AV0SQX4D) 
TITANIUM DIOXIDE(15FIX9V2JP)