Fenofibrate

Product NDC
63304-449
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
fenofibrate
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Sun Pharmaceutical Industries, Inc.
Application
ANDA200884
Marketing category
ANDA
Substance
FENOFIBRATE
Current FDA listing
Yes

Related Records

Packages

Package NDCDescriptionMarketing startMarketing endSampleStatus
63304-449-05500 TABLET, FILM COATED in 1 BOTTLE (63304-449-05) 2018-06-01NoHistorical
63304-449-3030 TABLET, FILM COATED in 1 BOTTLE (63304-449-30) 2018-06-01NoHistorical
63304-449-9090 TABLET, FILM COATED in 1 BOTTLE (63304-449-90) 2018-06-01NoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
These highlights do not include all the information needed to use FENOFIBRATE TABLETS safely and effectively. See full prescribing information for FENOFIBRATE TABLETS. FENOFIBRATE tablet, for oral use Initial U.S. Approval: 1993Northwind Health Company, LLC2026-01-01HUMAN PRESCRIPTION DRUG LABEL2
These highlights do not include all the information needed to use FENOFIBRATE TABLETS safely and effectively. See full prescribing information for FENOFIBRATE TABLETS. FENOFIBRATE tablet, for oral use Initial U.S. Approval: 1993Bryant Ranch Prepack2025-03-28HUMAN PRESCRIPTION DRUG LABEL5
These highlights do not include all the information needed to use FENOFIBRATE TABLETS safely and effectively. See full prescribing information for FENOFIBRATE TABLETS. FENOFIBRATE tablet, for oral use Initial U.S. Approval: 1993Sun Pharmaceutical Industries, Inc. | Sun Pharmaceutical Industries Limited2025-01-29HUMAN PRESCRIPTION DRUG LABEL12
These highlights do not include all the information needed to use FENOFIBRATE TABLETS safely and effectively. See full prescribing information for FENOFIBRATE TABLETS. FENOFIBRATE tablet, for oral use Initial U.S. Approval: 1993A-S Medication Solutions2023-04-19HUMAN PRESCRIPTION DRUG LABEL4
These highlights do not include all the information needed to use FENOFIBRATE TABLETS safely and effectively. See full prescribing information for FENOFIBRATE TABLETS. FENOFIBRATE tablet, for oral use Initial U.S. Approval: 1993Denton Pharma, Inc. DBA Northwind Pharmaceuticals2021-01-13HUMAN PRESCRIPTION DRUG LABEL2