Sold as Hydeltra-Tba. Every FDA application for this active ingredient: 1 branded and 1 generic.
As of Nov 15, 2026, FDA lists 2 applications for Prednisolone Tebutate (sold as Hydeltra-Tba), first approved Jul 25, 1956, with 0 new uses approved and 0 published complete response letters.
| Jul 25, 1956 | Hydeltra-TbaNDA 10562 · New active ingredient | Merck | 11 | Discontinued |
| — | Prednisolone TebutateANDA 83362 | Watson Labs | 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
