FDA
Azilsartan Medoxomil
The FDA lists this product in 3 strengths and forms.
Composition
- Active ingredients
- AZILSARTAN MEDOXOMIL 20MG
Strengths and forms
The FDA lists each strength of a product separately; these pages share one label.
- AZILSARTAN MEDOXOMIL 20MG · TabletThis page
- AZILSARTAN MEDOXOMIL 80MG · TabletANDA219062-001 · Tentative approval
- AZILSARTAN MEDOXOMIL 40MG · TabletANDA219062-002 · Tentative approval
Official product information
Drugs@FDA lists the approved labels, letters and reviews for application ANDA219062.
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
- Azilsartan Medoxomil
- Dosage form
- Tablet
- Applicant
- Hetero Labs Limited
- Status
- Tentative approval
- FDA approval
- 19 Mar 2025
- Application
- ANDA219062-003