Sold as Tornalate. Every FDA application for this active ingredient.
As of Nov 15, 2026, FDA lists 2 applications for Bitolterol Mesylate (sold as Tornalate), first approved Dec 28, 1984, with 2 new uses approved and 0 published complete response letters.
| Dec 28, 1984 | TornalateNDA 18770 · New molecular entity | Sanofi Aventis US | 15 | Discontinued |
| Feb 19, 1992 | TornalateNDA 19548 · New dosage form | Sanofi Aventis US | 4 | 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
Sanofi Aventis US