Composition
- Active ingredients
- DRONEDARONE 400MG
Strengths and forms
The FDA lists each strength of a product separately; these pages share one label.
- DRONEDARONE 400MG · TabletANDA206649-001 · Tentative approval
- DRONEDARONE 400MG · TabletThis page
Official product information
Drugs@FDA lists the approved labels, letters and reviews for application ANDA210678.
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
- Dronedarone
- Route
- Oral
- Dosage form
- Tablet
- Applicant
- Aurobindo Pharma LTD
- Status
- Tentative approval
- FDA approval
- 27 Apr 2023
- Application
- ANDA210678-001