Sold as Synalgos-Dc. Every FDA application for this active ingredient.
As of Nov 15, 2026, FDA lists 1 application for Aspirin; Caffeine; Dihydrocodeine Bitartrate (sold as Synalgos-Dc), first approved Jul 7, 1958, with 0 new uses approved and 0 published complete response letters.
| Approved | Application | Sponsor | Supplements | Marketing |
|---|---|---|---|---|
| Jul 7, 1958 | Synalgos-DcNDA 11483 ยท New combination | Sun Pharm Industries | 19 | 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
Sun Pharm Industries