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): 019304
Company: ABBVIE

Products on NDA 019304

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
LIPIDIL	FENOFIBRATE	100MG	CAPSULE;ORAL	Discontinued	None	No	No
TRICOR (MICRONIZED)	FENOFIBRATE	67MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE;ORAL	Discontinued	None	Yes	No
TRICOR (MICRONIZED)	FENOFIBRATE	134MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE;ORAL	Discontinued	None	Yes	No
TRICOR (MICRONIZED)	FENOFIBRATE	200MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE;ORAL	Discontinued	None	Yes	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 019304

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
12/31/1993	ORIG-1	Approval	Type 1 - New Molecular Entity	STANDARD	Review (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/019304_s000.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
03/19/2002	SUPPL-6	Manufacturing (CMC)-Control		Label is not available on this site.
04/24/2000	SUPPL-5	Efficacy-New Indication	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/19304-S005_Tricor_prntlbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/19304S5LTR.PDF https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/19304-S005_Tricor.cfm
06/28/1999	SUPPL-4	Manufacturing (CMC)-Packaging		Label is not available on this site.
06/30/1999	SUPPL-3	Manufacturing (CMC)-Formulation		Label is not available on this site.
04/27/1999	SUPPL-2	Manufacturing (CMC)		Label is not available on this site.
02/09/1998	SUPPL-1	Manufacturing (CMC)-Formulation	Review (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/nda/98/019304a_s001.pdf

Labels for NDA 019304

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
04/24/2000	SUPPL-5	Efficacy-New Indication	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/19304-S005_Tricor_prntlbl.pdf

Top