Treats Attention Deficit Hyperactivity Disorder (ADHD). Sold as Dyanavel Xr, Dyanavel Xr 5, Dyanavel Xr 10, Dyanavel Xr 15, Dyanavel Xr 20. Every FDA application for this active ingredient.
As of Nov 15, 2026, FDA lists 2 applications for Amphetamine; Amphetamine Aspartate/Dextroamphetamine Sulfate (sold as Dyanavel Xr, Dyanavel Xr 5, Dyanavel Xr 10 and others), first approved Oct 19, 2015, with 1 new use approved and 2 published complete response letters.
| Oct 19, 2015 | Dyanavel XrNDA 208147 · New dosage form | Tris Pharma Inc | 7 | Marketed |
| Nov 4, 2021 | Dyanavel Xr 5, Dyanavel Xr 10NDA 210526 · New dosage form | Tris Pharma Inc | 5 | Marketed |
| Jan 21, 2021 | Dyanavel XR (amphetamine)Facility Inspections | Approved |
| Jul 25, 2018 | Dyanavel XR (amphetamine)Facility Inspections | Approved |
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
