Choline Fenofibrate

Applications

NDAs, BLAs and generic ANDAs for this ingredient, oldest first; each opens its full history

Approved	Application	Sponsor	Supplements	Marketing
Dec 15, 2008	TrilipixNDA 22224 · New active ingredient	Abbvie	16	Discontinued
Mar 25, 2013	Fenofibric AcidANDA 200913	Pharmobedient	4	Discontinued
Jul 18, 2013	Fenofibric AcidANDA 201573	Ph Health	2	Discontinued
Dec 4, 2013	Fenofibric AcidANDA 200750	Chartwell Rx	6	Marketed
Oct 7, 2015	Fenofibric AcidANDA 200920	Actavis Elizabeth	1	Marketed
Sep 7, 2016	Fenofibric AcidANDA 200264	Impax Labs Inc	4	Marketed
May 12, 2017	Fenofibric AcidANDA 208705	Alembic	5	Marketed
Jul 5, 2019	Fenofibric AcidANDA 210469	Twi Pharms	1	Discontinued
Jul 18, 2019	Fenofibric AcidANDA 211626	Rising	2	Marketed
Jul 25, 2019	Fenofibric AcidANDA 212598	Aurobindo Pharma Ltd	2	Marketed
Jun 16, 2020	Fenofibric AcidANDA 213450	Micro Labs	2	Discontinued
Dec 23, 2020	Fenofibric AcidANDA 212562	Yichang Humanwell	2	Marketed
Feb 8, 2024	Fenofibric AcidANDA 207796	Macleods Pharms	1	Discontinued

Applications, approvals and products come from FDA's Drugs@FDA data files, refreshed weekly, grouped by active ingredient as FDA spells it. Complete response letters are FDA's published letters. Medicare spending is CMS's Part D and Part B dashboard, matched to this ingredient by generic name; shortages are FDA's shortage list, matched by application number; clinical trials are ClinicalTrials.gov studies naming the ingredient as an intervention, refreshed daily; safety programs are FDA's REMS list, matched by application number or, for shared programs, by ingredient. Drugs@FDA