FDA
Dronedarone Hydrochloride
The FDA lists this product in 5 strengths and forms.
Composition
- Active ingredients
- DRONEDARONE HYDROCHLORIDE EQ 400MG BASE
Strengths and forms
The FDA lists each strength of a product separately; these pages share one label.
- DRONEDARONE HYDROCHLORIDE 400MG · TabletANDA205682-001 · Tentative approval
- DRONEDARONE HYDROCHLORIDE 400MG · TabletANDA205744-001 · Tentative approval
- DRONEDARONE HYDROCHLORIDE EQ 400MG BASE · TabletThis page
- DRONEDARONE HYDROCHLORIDE 400MG · TabletANDA205895-001 · Tentative approval
- DRONEDARONE HYDROCHLORIDE 400MG · TabletANDA205903-001 · Tentative approval
Official product information
Drugs@FDA lists the approved labels, letters and reviews for application ANDA205904.
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 Hydrochloride
- Route
- Oral
- Dosage form
- Tablet
- Applicant
- Lupin
- Status
- Discontinued
- FDA approval
- 31 Jan 2024
- Application
- ANDA205904-001