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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 022224
Company: ABBVIE

Summary Review

Products on NDA 022224

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CHOLINE FENOFIBRATE	EQ 45MG FENOFIBRIC ACID Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE, DELAYED RELEASE;ORAL	Discontinued	None	Yes	No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CHOLINE FENOFIBRATE	EQ 135MG FENOFIBRIC ACID Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE, DELAYED RELEASE;ORAL	Discontinued	None	Yes	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 022224

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
12/15/2008	ORIG-1	Approval	Type 2 - New Active Ingredient	STANDARD	Label (PDF) Letter (PDF) Review Summary Review (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/022224s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/022224s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/022224_trilipix_toc.html https://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/022224s000_SumR.pdf

Supplements

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) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/022224s018lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/021656s032,022224s018ltr.pdf
06/03/2021	SUPPL-17	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/022224s016s017lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/022224Orig1s016, s017; 021656Orig1s030, s031ltr.pdf
06/03/2021	SUPPL-16	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/022224s016s017lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/022224Orig1s016, s017; 021656Orig1s030, s031ltr.pdf
03/28/2019	SUPPL-15	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/022224s015lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/021203Orig1s009, 021656Orig1s029, 022224Orig1s015ltr.pdf
11/07/2018	SUPPL-14	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022224s014lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/022224Orig1s014ltr.pdf
05/18/2018	SUPPL-13	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022224s013lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/022224Orig1s013ltr.pdf
11/18/2015	SUPPL-12	Manufacturing (CMC)		Label is not available on this site.
04/27/2015	SUPPL-11	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022224Orig1s011lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/022224Orig1s011ltr.pdf
04/17/2015	SUPPL-10	Manufacturing (CMC)		Label is not available on this site.
01/28/2013	SUPPL-9	Manufacturing (CMC)		Label is not available on this site.
09/05/2012	SUPPL-8	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022224s007s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022224Orig1s008ltr.pdf
09/05/2012	SUPPL-7	Manufacturing (CMC)	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022224s007s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022224Orig1s008ltr.pdf
09/30/2011	SUPPL-6	REMS-Assessment, REMS-Modified	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022224s005s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022224s005,s006ltr.pdf
09/30/2011	SUPPL-5	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022224s005s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022224s005,s006ltr.pdf
03/14/2011	SUPPL-4	Labeling	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022224s004ltr.pdf
09/14/2010	SUPPL-3	Labeling	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022224s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022224s003ltr.pdf

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

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