NDA 21203, held by Abbvie. Fenofibrate.
As of Nov 14, 2026, NDA 21203 (Tricor), held by Abbvie, was first approved by FDA on Sep 4, 2001, with 5 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Sep 4, 2001 | Original applicationNew dosage form · Standard review | Approved |
| Tricor54MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · tablet;oral | Fenofibrate | DiscontinuedReference drug |
| Tricor160MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · tablet;oral | Fenofibrate | DiscontinuedReference drug |
| Mar 28, 2019 | Supplement 9Labeling · Standard review | Approved | |
| Nov 6, 2018 | Supplement 8Labeling · Standard review | Approved | |
| May 18, 2018 | Supplement 7Labeling | Approved | |
| Jan 25, 2017 | Supplement 6Labeling · Standard review | Approved | |
| Dec 5, 2014 | Supplement 5Labeling · Standard review | Approved | |
| Sep 4, 2001 | Original applicationNew dosage form · Standard review | Approved |
Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters
