Composition
- Active ingredients
- AZELASTINE HYDROCHLORIDE 0.2055MG/SPRAY
Strengths and forms
The FDA lists each strength of a product separately; these pages share one label.
- AZELASTINE HYDROCHLORIDE 0.137MG/SPRAY **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · Spray, meteredNDA022203-001 · Discontinued
- AZELASTINE HYDROCHLORIDE 0.2055MG/SPRAY · Spray, meteredThis page
Official product information
Drugs@FDA lists the approved labels, letters and reviews for application NDA022203.
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
- Astepro
- Active substance
- azelastine hydrochloride
- Route
- Nasal
- Dosage form
- Spray, metered
- Applicant
- Viatris
- Status
- Discontinued
- FDA approval
- 15 Oct 2008
- Application
- NDA022203-002