NDA 19121, held by B Braun. Bretylium Tosylate.
As of Nov 13, 2026, NDA 19121 (Bretylium Tosylate In Dextrose 5% In Plastic Container), held by B Braun, was first approved by FDA on Apr 29, 1986, with 2 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Apr 29, 1986 | Original applicationNew formulation or manufacturer · Standard review | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Bretylium Tosylate In Dextrose 5% In Plastic Container100MG/100ML · injectable;injection | Bretylium Tosylate | Discontinued |
| Bretylium Tosylate In Dextrose 5% In Plastic Container200MG/100ML · injectable;injection | Bretylium Tosylate | Discontinued |
| Bretylium Tosylate In Dextrose 5% In Plastic Container400MG/100ML · injectable;injection | Bretylium Tosylate | Discontinued |
| Date | Submission | Status | Documents |
|---|---|---|---|
| Oct 6, 1993 | Supplement 3Labeling · Standard review | Approved | None posted |
| Jul 13, 1990 | Supplement 2Manufacturing · Standard review | Approved | None posted |
| Apr 29, 1986 | Original applicationNew formulation or manufacturer · Standard review | Approved | None posted |
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
