MedPath
FDA Approval

Fenofibrate

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

FDA Approval Summary

Company
Major Pharmaceuticals
DUNS: 191427277
Effective Date
April 25, 2025
Labeling Type
HUMAN PRESCRIPTION DRUG LABEL
Fenofibrate(145 mg in 1 1)

Products1

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

Fenofibrate

Product Details

NDC Product Code
0904-7480
Application Number
ANDA090856
Marketing Category
ANDA (C73584)
Route of Administration
ORAL
Effective Date
April 25, 2025
Code: U202363UOSClass: ACTIBQuantity: 145 mg in 1 1
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4Class: IACT
CROSPOVIDONE (120 .MU.M)Inactive
Code: 68401960MKClass: IACT
HYPROMELLOSE 2910 (3 MPA.S)Inactive
Code: 0VUT3PMY82Class: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5XClass: IACT
POLACRILIN POTASSIUMInactive
Code: 0BZ5A00FQUClass: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141JClass: IACT
SUCROSEInactive
Code: C151H8M554Class: IACT
© Copyright 2025. All Rights Reserved by MedPath