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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	CAPSULE, DELAYED RELEASE;ORAL	Prescription	AB	Yes	No
TRILIPIX	CHOLINE FENOFIBRATE	EQ 135MG FENOFIBRIC ACID	CAPSULE, DELAYED RELEASE;ORAL	Prescription	AB	Yes	Yes

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.cfm 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
06/03/2021	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
06/03/2021	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

Therapeutic Equivalents for NDA 022224

TRILIPIX

CAPSULE, DELAYED RELEASE;ORAL; EQ 45MG FENOFIBRIC ACID
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
FENOFIBRIC ACID	CHOLINE FENOFIBRATE	EQ 45MG FENOFIBRIC ACID	CAPSULE, DELAYED RELEASE;ORAL	Prescription	No	AB	200920	ACTAVIS ELIZABETH
FENOFIBRIC ACID	CHOLINE FENOFIBRATE	EQ 45MG FENOFIBRIC ACID	CAPSULE, DELAYED RELEASE;ORAL	Prescription	No	AB	208705	ALEMBIC
FENOFIBRIC ACID	CHOLINE FENOFIBRATE	EQ 45MG FENOFIBRIC ACID	CAPSULE, DELAYED RELEASE;ORAL	Prescription	No	AB	212598	AUROBINDO PHARMA LTD
FENOFIBRIC ACID	CHOLINE FENOFIBRATE	EQ 45MG FENOFIBRIC ACID	CAPSULE, DELAYED RELEASE;ORAL	Prescription	No	AB	200750	CHARTWELL RX
FENOFIBRIC ACID	CHOLINE FENOFIBRATE	EQ 45MG FENOFIBRIC ACID	CAPSULE, DELAYED RELEASE;ORAL	Prescription	No	AB	211626	GRAVITI PHARMS
FENOFIBRIC ACID	CHOLINE FENOFIBRATE	EQ 45MG FENOFIBRIC ACID	CAPSULE, DELAYED RELEASE;ORAL	Prescription	No	AB	200264	IMPAX LABS INC
FENOFIBRIC ACID	CHOLINE FENOFIBRATE	EQ 45MG FENOFIBRIC ACID	CAPSULE, DELAYED RELEASE;ORAL	Prescription	No	AB	207796	MACLEODS PHARMS LTD
FENOFIBRIC ACID	CHOLINE FENOFIBRATE	EQ 45MG FENOFIBRIC ACID	CAPSULE, DELAYED RELEASE;ORAL	Prescription	No	AB	213450	MICRO LABS
FENOFIBRIC ACID	CHOLINE FENOFIBRATE	EQ 45MG FENOFIBRIC ACID	CAPSULE, DELAYED RELEASE;ORAL	Prescription	No	AB	210469	TWI PHARMS
FENOFIBRIC ACID	CHOLINE FENOFIBRATE	EQ 45MG FENOFIBRIC ACID	CAPSULE, DELAYED RELEASE;ORAL	Prescription	No	AB	212562	YICHANG HUMANWELL
TRILIPIX	CHOLINE FENOFIBRATE	EQ 45MG FENOFIBRIC ACID	CAPSULE, DELAYED RELEASE;ORAL	Prescription	Yes	AB	022224	ABBVIE

CAPSULE, DELAYED RELEASE;ORAL; EQ 135MG FENOFIBRIC ACID
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
FENOFIBRIC ACID	CHOLINE FENOFIBRATE	EQ 135MG FENOFIBRIC ACID	CAPSULE, DELAYED RELEASE;ORAL	Prescription	No	AB	200920	ACTAVIS ELIZABETH
FENOFIBRIC ACID	CHOLINE FENOFIBRATE	EQ 135MG FENOFIBRIC ACID	CAPSULE, DELAYED RELEASE;ORAL	Prescription	No	AB	208705	ALEMBIC
FENOFIBRIC ACID	CHOLINE FENOFIBRATE	EQ 135MG FENOFIBRIC ACID	CAPSULE, DELAYED RELEASE;ORAL	Prescription	No	AB	212598	AUROBINDO PHARMA LTD
FENOFIBRIC ACID	CHOLINE FENOFIBRATE	EQ 135MG FENOFIBRIC ACID	CAPSULE, DELAYED RELEASE;ORAL	Prescription	No	AB	200750	CHARTWELL RX
FENOFIBRIC ACID	CHOLINE FENOFIBRATE	EQ 135MG FENOFIBRIC ACID	CAPSULE, DELAYED RELEASE;ORAL	Prescription	No	AB	211626	GRAVITI PHARMS
FENOFIBRIC ACID	CHOLINE FENOFIBRATE	EQ 135MG FENOFIBRIC ACID	CAPSULE, DELAYED RELEASE;ORAL	Prescription	No	AB	200264	IMPAX LABS INC
FENOFIBRIC ACID	CHOLINE FENOFIBRATE	EQ 135MG FENOFIBRIC ACID	CAPSULE, DELAYED RELEASE;ORAL	Prescription	No	AB	207796	MACLEODS PHARMS LTD
FENOFIBRIC ACID	CHOLINE FENOFIBRATE	EQ 135MG FENOFIBRIC ACID	CAPSULE, DELAYED RELEASE;ORAL	Prescription	No	AB	213450	MICRO LABS
FENOFIBRIC ACID	CHOLINE FENOFIBRATE	EQ 135MG FENOFIBRIC ACID	CAPSULE, DELAYED RELEASE;ORAL	Prescription	No	AB	210469	TWI PHARMS
FENOFIBRIC ACID	CHOLINE FENOFIBRATE	EQ 135MG FENOFIBRIC ACID	CAPSULE, DELAYED RELEASE;ORAL	Prescription	No	AB	212562	YICHANG HUMANWELL
TRILIPIX	CHOLINE FENOFIBRATE	EQ 135MG FENOFIBRIC ACID	CAPSULE, DELAYED RELEASE;ORAL	Prescription	Yes	AB	022224	ABBVIE

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