NDA 19837, held by Baxter Hlthcare. Bretylium Tosylate.
As of Nov 13, 2026, NDA 19837 (Bretylium Tosylate In Dextrose 5% In Plastic Container), held by Baxter Hlthcare, was not approved, with 0 approved supplements and 0 published complete response letters.
| Bretylium Tosylate In Dextrose 5% In Plastic Container400MG/100ML · injectable;injection | Bretylium Tosylate | Discontinued |
| Bretylium Tosylate In Dextrose 5% In Plastic Container200MG/100ML · injectable;injection | Bretylium Tosylate | Discontinued |
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
