Treats migraine with or without aura. Sold as Treximet. Every FDA application for this active ingredient: 1 branded and 3 generic.
As of Nov 15, 2026, FDA lists 4 applications for Naproxen Sodium; Sumatriptan Succinate (sold as Treximet), first approved Apr 15, 2008, with 1 new use approved and 0 published complete response letters.
| Apr 15, 2008 | TreximetNDA 21926 ยท New combination | Azurity | 12 | Marketed |
| Feb 15, 2018 | Sumatriptan And Naproxen SodiumANDA 207457 | Aurobindo Pharma Ltd | 1 | Marketed |
| Jul 20, 2018 | Sumatriptan And Naproxen SodiumANDA 202803 | Sun Pharm | 4 | Marketed |
| Sep 4, 2018 | Sumatriptan And Naproxen SodiumANDA 90872 | Rising | 2 | Marketed |
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
