An official website of the United States government Here's how you know

The .gov means it's official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you're on a federal government site.

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

New Drug Application (NDA): 021656
Company: ABBVIE

Products on NDA 021656

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
TRICOR	FENOFIBRATE	48MG	TABLET;ORAL	Prescription	AB	Yes	No
TRICOR	FENOFIBRATE	145MG	TABLET;ORAL	Discontinued	None	Yes	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 021656

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
11/05/2004	ORIG-1	Approval	Type 5 - New Formulation or New Manufacturer	STANDARD	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21656lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21656ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/021656s000_TricorTOC.cfm

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
06/03/2021	SUPPL-31	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/021656s030s031lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/022224Orig1s016, s017; 021656Orig1s030, s031ltr.pdf
06/03/2021	SUPPL-30	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/021656s030s031lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/022224Orig1s016, s017; 021656Orig1s030, s031ltr.pdf
03/28/2019	SUPPL-29	Labeling-Patient Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021656s029lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/021203Orig1s009, 021656Orig1s029, 022224Orig1s015ltr.pdf
11/06/2018	SUPPL-27	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021656s027lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/021203Orig1s008,021656Orig1s027ltr.pdf
05/18/2018	SUPPL-26	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021656s026,021203s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/021203Orig1s007,021656Orig1s026ltr.pdf
04/17/2015	SUPPL-25	Manufacturing (CMC)		Label is not available on this site.
08/25/2014	SUPPL-24	Manufacturing (CMC)		Label is not available on this site.
02/05/2013	SUPPL-23	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021656s023lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021656Orig1s023ltr.pdf
09/22/2011	SUPPL-20	Labeling	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021656s020lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021656s020ltr.pdf
10/20/2010	SUPPL-19	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021656s019lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021656s019ltr.pdf
04/15/2008	SUPPL-13	Labeling	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021249s019,021656s013ltr.pdf
09/10/2007	SUPPL-11	Labeling		Label is not available on this site.
09/10/2007	SUPPL-4	Labeling	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021656s004,s011ltr.pdf

Labels for NDA 021656

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
06/03/2021	SUPPL-31	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/021656s030s031lbl.pdf
06/03/2021	SUPPL-30	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/021656s030s031lbl.pdf
03/28/2019	SUPPL-29	Labeling-Patient Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021656s029lbl.pdf
11/06/2018	SUPPL-27	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021656s027lbl.pdf
05/18/2018	SUPPL-26	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021656s026,021203s007lbl.pdf
02/05/2013	SUPPL-23	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021656s023lbl.pdf
09/22/2011	SUPPL-20	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021656s020lbl.pdf
10/20/2010	SUPPL-19	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021656s019lbl.pdf
11/05/2004	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21656lbl.pdf

Therapeutic Equivalents for NDA 021656

TRICOR

TABLET;ORAL; 48MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
FENOFIBRATE	FENOFIBRATE	48MG	TABLET;ORAL	Prescription	No	AB	210476	ALEMBIC
FENOFIBRATE	FENOFIBRATE	48MG	TABLET;ORAL	Prescription	No	AB	209951	AMNEAL
FENOFIBRATE	FENOFIBRATE	48MG	TABLET;ORAL	Prescription	No	AB	205118	AUROBINDO PHARMA
FENOFIBRATE	FENOFIBRATE	48MG	TABLET;ORAL	Prescription	No	AB	208476	AUSTARPHARMA
FENOFIBRATE	FENOFIBRATE	48MG	TABLET;ORAL	Prescription	No	AB	208709	CIPLA
FENOFIBRATE	FENOFIBRATE	48MG	TABLET;ORAL	Prescription	No	AB	211122	GRAVITI PHARMS
FENOFIBRATE	FENOFIBRATE	48MG	TABLET;ORAL	Prescription	No	AB	204598	HETERO LABS LTD III
FENOFIBRATE	FENOFIBRATE	48MG	TABLET;ORAL	Prescription	No	AB	090856	LUPIN LTD
FENOFIBRATE	FENOFIBRATE	48MG	TABLET;ORAL	Prescription	No	AB	202856	MYLAN PHARMS INC
FENOFIBRATE	FENOFIBRATE	48MG	TABLET;ORAL	Prescription	No	AB	211080	PRINSTON INC
FENOFIBRATE	FENOFIBRATE	48MG	TABLET;ORAL	Prescription	No	AB	200884	SUN PHARM
FENOFIBRATE	FENOFIBRATE	48MG	TABLET;ORAL	Prescription	No	AB	090715	VALEANT PHARMS NORTH
TRICOR	FENOFIBRATE	48MG	TABLET;ORAL	Prescription	Yes	AB	021656	ABBVIE

Top