MedPath
FDA Product

Fenofibrate

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

Basic Information

Fenofibrate

0115-0533

Regulatory Information

0115-0533

ANDA075868

C73584

September 7, 2022

USA

Fenofibrate Capsules, Micronized

HUMAN PRESCRIPTION DRUG LABEL

48

Company Information

123797875

Active Ingredients

FENOFIBRATE

Quantity: 200 mg in 1 1

Code: U202363UOS

Class Code: ACTIB

MAGNESIUM STEARATE

Code: 70097M6I30

Class Code: IACT

CROSCARMELLOSE SODIUM

Code: M28OL1HH48

Class Code: IACT

CELLULOSE, MICROCRYSTALLINE

Code: OP1R32D61U

Class Code: IACT

GELATIN

Code: 2G86QN327L

Class Code: IACT

SODIUM LAURYL SULFATE

Code: 368GB5141J

Class Code: IACT

TITANIUM DIOXIDE

Code: 15FIX9V2JP

Class Code: IACT

D&C RED NO. 28

Code: 767IP0Y5NH

Class Code: IACT

FERROSOFERRIC OXIDE

Code: XM0M87F357

Class Code: IACT

PROPYLENE GLYCOL

Code: 6DC9Q167V3

Class Code: IACT

FD&C BLUE NO. 2

Code: L06K8R7DQK

Class Code: IACT

ALUMINUM OXIDE

Code: LMI26O6933

Class Code: IACT

HYPROMELLOSE 2910 (6 MPA.S)

Code: 0WZ8WG20P6

Class Code: IACT

D&C YELLOW NO. 10

Code: 35SW5USQ3G

Class Code: IACT

FD&C RED NO. 40

Code: WZB9127XOA

Class Code: IACT

SHELLAC

Code: 46N107B71O

Class Code: IACT

FD&C BLUE NO. 1

Code: H3R47K3TBD

Class Code: IACT

Active Moieties

FENOFIBRIC ACID

Code: BGF9MN2HU1

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