Composition
- Active ingredients
- DRONEDARONE 400MG
Strengths and forms
The FDA lists each strength of a product separately; these pages share one label.
- DRONEDARONE 400MG · TabletThis page
- DRONEDARONE 400MG · TabletANDA210678-001 · Tentative approval
Official product information
Drugs@FDA lists the approved labels, letters and reviews for application ANDA206649.
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
- Amneal Pharms
- Status
- Tentative approval
- FDA approval
- 12 May 2017
- Application
- ANDA206649-001