Sold as Bretylol, Bretylium Tosylate In Dextrose 5%, Bretylium Tosylate In Dextrose 5% In Plastic Container, Bretylium Tosylate. Every FDA application for this active ingredient: 7 branded and 11 generic.
As of Nov 15, 2026, FDA lists 18 applications for Bretylium Tosylate (sold as Bretylol, Bretylium Tosylate In Dextrose 5%, Bretylium Tosylate In Dextrose 5% In Plastic Container and others), first approved Apr 16, 1986, with 0 new uses approved and 0 published complete response letters.
| Mar 6, 1986 | Bretylium TosylateANDA 70119 | Intl Medication | 12 | Discontinued |
| Apr 16, 1986 | Bretylium Tosylate In Dextrose 5%NDA 19005 · New formulation or manufacturer | Abbott | 0 | Discontinued |
| Apr 16, 1986 | Bretylium Tosylate In Dextrose 5% In Plastic ContainerNDA 19008 · New dosage form | Hospira Inc | 20 | Discontinued |
| Apr 16, 1986 | Bretylium TosylateNDA 19030 · New formulation or manufacturer | Hospira | 11 | Discontinued |
| Apr 16, 1986 | Bretylium TosylateNDA 19033 · New formulation or manufacturer | Hospira | 7 | Discontinued |
| Apr 29, 1986 | Bretylium Tosylate In Dextrose 5% In Plastic ContainerNDA 19121 · New formulation or manufacturer | B Braun | 2 | Discontinued |
| May 14, 1986 | Bretylium TosylateANDA 70545 | Hikma | 6 | Discontinued |
| May 14, 1986 | Bretylium TosylateANDA 70546 | Hikma | 6 | Discontinued |
| Jul 26, 1988 | Bretylium TosylateANDA 70891 | Luitpold | 10 | Discontinued |
| Dec 21, 2018 | Bretylium TosylateANDA 204386 | Breckenridge | 0 | Discontinued |
| — | Bretylium TosylateANDA 70134 | Abraxis Pharm | 0 | Discontinued |
| — | Bretylium TosylateANDA 71151 | Astrazeneca | 0 | Discontinued |
| — | Bretylium TosylateANDA 71152 | Astrazeneca | 0 | Discontinued |
| — | Bretylium TosylateANDA 71153 | Astrazeneca | 0 | Discontinued |
| — | Bretylium TosylateANDA 71181 | Quad Pharms | 0 | Discontinued |
| — | Bretylium TosylateANDA 71298 | Abraxis Pharm | 0 | Discontinued |
| — | BretylolNDA 17954 | Hospira | 0 | Discontinued |
| — | Bretylium Tosylate In Dextrose 5% In Plastic ContainerNDA 19837 | Baxter Hlthcare | 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
Abbott
Hikma
Abraxis Pharm
Astrazeneca
Baxter Hlthcare