Sold as Antizol. Every FDA application for this active ingredient: 1 branded and 5 generic.
As of Nov 15, 2026, FDA lists 6 applications for Fomepizole (sold as Antizol), first approved Dec 4, 1997, with 1 new use approved and 0 published complete response letters.
| Dec 4, 1997 | AntizolNDA 20696 · New molecular entity | Par Pharm Inc | 3 | Discontinued |
| Dec 14, 2007 | FomepizoleANDA 78368 | Am Regent | 1 | Marketed |
| Mar 3, 2008 | FomepizoleANDA 78639 | Mylan Institutional | 1 | Marketed |
| Mar 6, 2008 | FomepizoleANDA 78537 | Navinta LLC | 3 | Marketed |
| Apr 7, 2009 | FomepizoleANDA 79033 | Mylan Institutional | 0 | Discontinued |
| Jul 6, 2023 | FomepizoleANDA 216791 | Gland | 0 | Marketed |
Applications, approvals and products come from FDA's Drugs@FDA data files, refreshed weekly, grouped by active ingredient as FDA spells it. Complete response letters are FDA's published letters. Medicare spending is CMS's Part D and Part B dashboard, matched to this ingredient by generic name; shortages are FDA's shortage list, matched by application number; clinical trials are ClinicalTrials.gov studies naming the ingredient as an intervention, refreshed daily; safety programs are FDA's REMS list, matched by application number or, for shared programs, by ingredient. Drugs@FDA
Par Pharm Inc