USFDA APPLICATION NUMBER - 21695 / DOSAGE - CAPSULE;ORAL - 130MG
Active Ingredient/Active Moiety | ||
Ingredient Name | Basis of Strength | Strength |
---|---|---|
FENOFIBRATE(UNII: U202363UOS) (FENOFIBRIC ACID - UNII:BGF9MN2HU1) | FENOFIBRATE | 30mg | 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) |
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