Sold as Ambenyl. Every FDA application for this active ingredient: 1 branded and 2 generic.
As of Nov 15, 2026, FDA lists 3 applications for Bromodiphenhydramine Hydrochloride; Codeine Phosphate (sold as Ambenyl), first approved Apr 28, 1954, with 1 new use approved and 0 published complete response letters.
| Apr 28, 1954 | AmbenylNDA 9319 · New combination | Forest Labs | 15 | Discontinued |
| Oct 12, 1984 | Bromodiphenhydramine Hydrochloride And Codeine PhosphateANDA 88626 | Wockhardt | 7 | Discontinued |
| — | BromanylANDA 88343 | Alpharma US Pharms | 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
Wockhardt