Sold as Fluothane. Every FDA application for this active ingredient: 1 branded and 3 generic.
As of Nov 14, 2026, FDA lists 4 applications for Halothane (sold as Fluothane), first approved Mar 12, 1958, with 0 new uses approved and 0 published complete response letters.
| Mar 12, 1958 | FluothaneNDA 11338 ยท New molecular entity | Wyeth Ayerst | 13 | Discontinued |
| May 9, 1972 | HalothaneANDA 80810 | Halocarbon | 9 | Discontinued |
| May 30, 1975 | HalothaneANDA 83254 | Hospira | 5 | Discontinued |
| Jul 14, 1976 | HalothaneANDA 84977 | Bh | 0 | Discontinued |
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
