Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 022224
Company: ABBVIE

• Summary Review

Products on NDA 22224

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
TRILIPIX	CHOLINE FENOFIBRATE	EQ 45MG FENOFIBRIC ACID **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**	CAPSULE, DELAYED RELEASE;ORAL	Discontinued	None	Yes	No
TRILIPIX	CHOLINE FENOFIBRATE	EQ 135MG FENOFIBRIC ACID **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**	CAPSULE, DELAYED RELEASE;ORAL	Discontinued	None	Yes	No

Labels for NDA 022224

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
06/06/2025	SUPPL-18	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/022224s018lbl.pdf
06/03/2021	SUPPL-17	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/022224s016s017lbl.pdf
06/03/2021	SUPPL-16	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/022224s016s017lbl.pdf
03/28/2019	SUPPL-15	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/022224s015lbl.pdf
11/07/2018	SUPPL-14	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022224s014lbl.pdf
05/18/2018	SUPPL-13	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022224s013lbl.pdf
04/27/2015	SUPPL-11	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022224Orig1s011lbl.pdf
09/05/2012	SUPPL-8	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022224s007s008lbl.pdf
09/05/2012	SUPPL-7	Manufacturing (CMC)	Label (PDF)	This supplement type does not usually require new labeling.	https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022224s007s008lbl.pdf
09/30/2011	SUPPL-6	REMS-Assessment	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022224s005s006lbl.pdf
09/30/2011	SUPPL-6	REMS-Modified	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022224s005s006lbl.pdf
09/30/2011	SUPPL-5	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022224s005s006lbl.pdf
09/14/2010	SUPPL-3	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022224s003lbl.pdf
12/15/2008	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/022224s000lbl.pdf