NDA 22418, held by Rosemont. Fenofibric Acid.
As of Nov 14, 2026, NDA 22418 (Fibricor), held by Rosemont, was first approved by FDA on Aug 14, 2009, with 12 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Aug 14, 2009 | Original applicationNew formulation or manufacturer · Standard review | Approved |
| Fibricor35MG · tablet;oral | Fenofibric Acid | DiscontinuedReference drug |
| Fibricor105MG · tablet;oral | Fenofibric Acid | DiscontinuedReference drug |
| Jun 6, 2025 | Supplement 20Labeling · Standard review | Approved | |
| Jun 3, 2021 | Supplement 19Labeling | Approved | |
| Sep 30, 2019 | Supplement 16Labeling · Standard review | Approved | |
| May 15, 2019 | Supplement 15Labeling | Approved | |
| May 18, 2018 | Supplement 14Labeling | Approved | |
| Nov 27, 2015 | Supplement 13Manufacturing · Standard review | Approved | None posted |
| Jan 6, 2014 | Supplement 11Labeling · Standard review | Approved | |
| Mar 11, 2013 | Supplement 10Labeling · Standard review | Approved | |
| Dec 12, 2012 | Supplement 8Labeling · Standard review | Approved | |
| Dec 12, 2012 | Supplement 9Labeling · Standard review | Approved | |
| Mar 15, 2012 | Supplement 7Labeling · Standard review | Approved | |
| Jan 3, 2012 | Supplement 6Labeling · Standard review | Approved | |
| Aug 14, 2009 | 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
