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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 021203
Company: ABBVIE

Products on NDA 021203

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
TRICOR	FENOFIBRATE	54MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET;ORAL	Discontinued	None	Yes	No
TRICOR	FENOFIBRATE	160MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET;ORAL	Discontinued	None	Yes	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 021203

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
09/04/2001	ORIG-1	Approval	Type 3 - New Dosage Form	STANDARD	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/21203lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/21203ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/21-203_Tricor.cfm

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
03/28/2019	SUPPL-9	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021203s009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/021203Orig1s009, 021656Orig1s029, 022224Orig1s015ltr.pdf
11/06/2018	SUPPL-8	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021203s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/021203Orig1s008,021656Orig1s027ltr.pdf
05/18/2018	SUPPL-7	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
01/25/2017	SUPPL-6	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021203s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/021203Orig1s006ltr.pdf
12/05/2014	SUPPL-5	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021203s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021203Orig1s005ltr.pdf

Labels for NDA 021203

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
03/28/2019	SUPPL-9	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021203s009lbl.pdf
11/06/2018	SUPPL-8	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021203s008lbl.pdf
05/18/2018	SUPPL-7	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021656s026,021203s007lbl.pdf
01/25/2017	SUPPL-6	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021203s006lbl.pdf
12/05/2014	SUPPL-5	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021203s005lbl.pdf
09/04/2001	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/21203lbl.pdf

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