Sold as Cafergot. Every FDA application for this active ingredient: 2 branded and 5 generic.
As of Nov 15, 2026, FDA lists 7 applications for Caffeine; Ergotamine Tartrate (sold as Cafergot), first approved Nov 26, 1948, with 0 new uses approved and 0 published complete response letters.
| Nov 26, 1948 | CafergotNDA 6620 | Novartis | 33 | Discontinued |
| Apr 24, 1953 | CafergotNDA 9000 ยท New combination | Novartis | 23 | Discontinued |
| Sep 29, 1976 | CafergotANDA 84294 | Chartwell Rx | 18 | Discontinued |
| Nov 5, 1980 | WigraineANDA 86562 | Organon USA Inc | 13 | Discontinued |
| Oct 4, 1983 | MigergotANDA 86557 | Cosette | 8 | Marketed |
| Sep 17, 2004 | Ergotamine Tartrate And CaffeineANDA 40510 | Hikma | 0 | Discontinued |
| Sep 16, 2005 | Ergotamine Tartrate And CaffeineANDA 40590 | Pharmobedient | 2 | 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
Novartis
Hikma