MedPath
FDA Product

FENOFIBRATE

Product approved by U.S. Food and Drug Administration (US)

Basic Information

FENOFIBRATE

72189-172

Regulatory Information

72189-172

ANDA210138

C73584

June 3, 2021

USA

FENOFIBRATE

HUMAN PRESCRIPTION DRUG LABEL

4

Company Information

Direct_Rx

079254320

Active Ingredients

SODIUM LAURYL SULFATE

Code: 368GB5141J

Class Code: IACT

POVIDONE, UNSPECIFIED

Code: FZ989GH94E

Class Code: IACT

POLYVINYL ALCOHOL, UNSPECIFIED

Code: 532B59J990

Class Code: IACT

CROSCARMELLOSE SODIUM

Code: M28OL1HH48

Class Code: IACT

FENOFIBRATE

Quantity: 160 mg in 1 1

Code: U202363UOS

Class Code: ACTIB

TITANIUM DIOXIDE

Code: 15FIX9V2JP

Class Code: IACT

XANTHAN GUM

Code: TTV12P4NEE

Class Code: IACT

SODIUM STARCH GLYCOLATE TYPE A CORN

Code: AG9B65PV6B

Class Code: IACT

LACTOSE MONOHYDRATE

Code: EWQ57Q8I5X

Class Code: IACT

TALC

Code: 7SEV7J4R1U

Class Code: IACT

CELLULOSE, MICROCRYSTALLINE

Code: OP1R32D61U

Class Code: IACT

SODIUM STEARYL FUMARATE

Code: 7CV7WJK4UI

Class Code: IACT

SILICON DIOXIDE

Code: ETJ7Z6XBU4

Class Code: IACT

CROSPOVIDONE, UNSPECIFIED

Code: 2S7830E561

Class Code: IACT

EGG PHOSPHOLIPIDS

Code: 1Z74184RGV

Class Code: IACT

Active Moieties

FENOFIBRIC ACID

Code: BGF9MN2HU1

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