Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 019304
Company: ABBVIE
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TRICOR (MICRONIZED) FENOFIBRATE 67MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** CAPSULE;ORAL Discontinued None Yes No
TRICOR (MICRONIZED) FENOFIBRATE 134MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** CAPSULE;ORAL Discontinued None Yes No
TRICOR (MICRONIZED) FENOFIBRATE 200MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** CAPSULE;ORAL Discontinued None Yes No
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
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

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