Composition
- Active ingredients
- BITOLTEROL MESYLATE 0.2%
Strengths and forms
The FDA lists each strength of a product separately; these pages share one label.
- BITOLTEROL MESYLATE 0.37MG/INH · Aerosol, meteredNDA018770-001 · Discontinued
- BITOLTEROL MESYLATE 0.2% · SolutionThis page
Official product information
Drugs@FDA lists the approved labels, letters and reviews for application NDA019548.
Prognia shows this product information for reference and learning. It is not treatment advice and can lag behind the official text. Always check the current product information and local protocols before prescribing.
At a glance
- Brand name
- Tornalate
- Active substance
- bitolterol mesylate
- Route
- Inhalation
- Dosage form
- Solution
- Applicant
- Sanofi Aventis US
- Status
- Discontinued
- FDA approval
- 19 Feb 1992
- Application
- NDA019548-001



