Sold as Ismelin. Every FDA application for this active ingredient: 1 branded and 2 generic.
As of Nov 15, 2026, FDA lists 3 applications for Guanethidine Monosulfate (sold as Ismelin), first approved Jul 5, 1960, with 0 new uses approved and 0 published complete response letters.
| Jul 5, 1960 | IsmelinNDA 12329 · New molecular entity | Novartis | 30 | Discontinued |
| — | Guanethidine MonosulfateANDA 86113 | Watson Labs | 0 | Discontinued |
| — | Guanethidine MonosulfateANDA 86114 | Watson Labs | 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
Novartis