NDA 22118, held by Salix. Fenofibrate.
As of Nov 14, 2026, NDA 22118 (Fenoglide), held by Salix, was first approved by FDA on Aug 10, 2007, with 8 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Aug 10, 2007 | Original applicationNew formulation or manufacturer · Standard review | Approved |
| Fenoglide40MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · tablet;oral | Fenofibrate | DiscontinuedReference drug |
| Fenoglide120MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · tablet;oral | Fenofibrate | DiscontinuedReference drug |
| Jun 6, 2025 | Supplement 14Labeling · Standard review | Approved | |
| Jun 3, 2021 | Supplement 13Labeling | Approved | |
| May 15, 2019 | Supplement 10Labeling | Approved | |
| Mar 13, 2019 | Supplement 9Labeling · Standard review | Approved | |
| May 18, 2018 | Supplement 7Labeling | Approved | |
| Oct 31, 2012 | Supplement 5Labeling · Standard review | Approved | |
| Mar 5, 2012 | Supplement 3Labeling · Standard review | Approved | |
| Feb 29, 2008 | Supplement 1Labeling · Standard review | Approved | |
| Aug 10, 2007 | Original applicationNew formulation or manufacturer · 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
