NDA 19304, held by Abbvie. Fenofibrate.
As of Nov 14, 2026, NDA 19304 (Lipidil, Tricor (Micronized)), held by Abbvie, was first approved by FDA on Dec 31, 1993, with 6 approved supplements and 0 published complete response letters.
| Apr 24, 2000 | Supplement 5Efficacy (new indication or use) | Approved | |
| Dec 31, 1993 | Original applicationNew molecular entity · Standard review | Approved |
| Lipidil100MG · capsule;oral | Fenofibrate | Discontinued |
| Tricor (Micronized)67MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · capsule;oral | Fenofibrate | DiscontinuedReference drug |
| Tricor (Micronized)134MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · capsule;oral | Fenofibrate | DiscontinuedReference drug |
| Tricor (Micronized)200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · capsule;oral | Fenofibrate | DiscontinuedReference drug |
| Mar 19, 2002 | Supplement 6Manufacturing · Standard review | Approved | None posted |
| Apr 24, 2000 | Supplement 5Efficacy (new indication or use) | Approved | |
| Jun 30, 1999 | Supplement 3Manufacturing · Standard review | Approved | None posted |
| Jun 28, 1999 | Supplement 4Manufacturing · Standard review | Approved | None posted |
| Apr 27, 1999 | Supplement 2Manufacturing · Standard review | Approved | None posted |
| Feb 9, 1998 | Supplement 1Manufacturing · Standard review | Approved | |
| Dec 31, 1993 | Original applicationNew molecular entity · 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
