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Setid 11085914 Cce2 4dbb Bae7 20bbe5af2fbb Applno 21695 Form Capsule Oral Dosage 43mg - Drug Product Composition: Lipanthyl

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$ API Ref.Price (USD/KG) : 86Xls

USFDA APPLICATION NUMBER - 21695 / DOSAGE - CAPSULE;ORAL - 43MG

Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
FENOFIBRATE(UNII: U202363UOS)
(FENOFIBRIC ACID - UNII:BGF9MN2HU1)
FENOFIBRATE30mg | 90mg

Inactive Ingredients

Ingredient Name
Mylan Pharmaceuticals Inc.
Dr. Reddy's Laboratories Limited
Lupin Pharmaceuticals, Inc.
AvKARE, Inc.
PD-Rx Pharmaceuticals, Inc.
Sun Pharmaceutical Industries, Inc.
AMMONIA(5138Q19F1X)     
AMMONIO METHACRYLATE COPOLYMER TYPE A(8GQS4E66YY)     
D&C YELLOW NO. 10(35SW5USQ3G)    
DIMETHICONE(92RU3N3Y1O) 
FD&C BLUE NO. 1(H3R47K3TBD)     
FD&C BLUE NO. 2(L06K8R7DQK)    
FD&C YELLOW NO. 6(H77VEI93A8)     
FERRIC OXIDE RED(1K09F3G675)     
FERRIC OXIDE YELLOW(EX438O2MRT)   
FERROSOFERRIC OXIDE(XM0M87F357)
GELATIN(2G86QN327L)    
GELATIN, UNSPECIFIED(2G86QN327L)  
HYPROMELLOSE 2910 (3 MPA.S)(0VUT3PMY82)     
HYPROMELLOSE, UNSPECIFIED(3NXW29V3WO)    
HYPROMELLOSES(3NXW29V3WO)   
LECITHIN, SOYBEAN(1DI56QDM62)     
METHYLCELLULOSE (400 MPA.S)(O0GN6F9B2Y)    
POLYSORBATE 65(14BGY2Y3MJ)   
POTASSIUM HYDROXIDE(WZH3C48M4T) 
PROPYLENE GLYCOL(6DC9Q167V3) 
RAW SUGAR(8M707QY5GH)     
SHELLAC(46N107B71O)
SILICON DIOXIDE(ETJ7Z6XBU4)  
SODIUM LAURYL SULFATE(368GB5141J)
SODIUM STEARYL FUMARATE(7CV7WJK4UI)   
STARCH, CORN(O8232NY3SJ)  
SUCROSE(C151H8M554)    
SULFUR DIOXIDE(0UZA3422Q4)     
TALC(7SEV7J4R1U)
TITANIUM DIOXIDE(15FIX9V2JP)
TRIETHYL CITRATE(8Z96QXD6UM)     
WATER(059QF0KO0R)