Sold as Flowtuss, Obredon, Xtrelus. Every FDA application for this active ingredient.
As of Nov 15, 2026, FDA lists 3 applications for Guaifenesin; Hydrocodone Bitartrate (sold as Flowtuss, Obredon, Xtrelus), first approved Nov 14, 2014, with 0 new uses approved and 0 published complete response letters.
| Study | Phase | Status | Posted |
|---|---|---|---|
| An Artificial Intelligence Driven Approach to Optimize Patient Selection for a Transitional Pain ServicePostsurgical Pain Management, Postsurgical Pain, Chronic · University of California, San Francisco | Phase 3 | Not yet recruiting | Dec 22, 2025 |
| Nov 14, 2014 | ObredonNDA 205474 · New combination | Sovereign Pharms | 5 | Discontinued |
| May 14, 2015 | FlowtussNDA 22424 · New combination | Chartwell Rx | 4 | Discontinued |
| Apr 25, 2018 | XtrelusNDA 208085 · TYPE 3/4 | Eci Pharms LLC | 3 | 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
