Fenofibrate

FDA-approved pharmaceutical product with comprehensive regulatory information, manufacturing details, and complete labeling documentation.

Company

DUNS: 079196022

Effective Date

March 1, 2022

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Active Ingredients

Fenofibrate(160 mg in 1 1)

Manufacturing Establishments1

FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.

Labeler

Proficient Rx LP

DUNS Number

079196022

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

NDC Product Code

71205-949

Application Number

ANDA207803

Marketing Category

ANDA (C73584)

Route of Administration

ORAL

Effective Date

March 1, 2022

Ingredients

Code: U202363UOSClass: ACTIBQuantity: 160 mg in 1 1