Composition
- Active ingredients
- EDOXABAN 60MG
Strengths and forms
The FDA lists each strength of a product separately; these pages share one label.
- EDOXABAN 60MG · TabletThis page
- EDOXABAN 15MG · TabletANDA213064-001 · Tentative approval
- EDOXABAN 30MG · TabletANDA213064-002 · Tentative approval
Official product information
Drugs@FDA lists the approved labels, letters and reviews for application ANDA213064.
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
- Edoxaban
- Route
- Oral
- Dosage form
- Tablet
- Applicant
- Zydus Pharms USA Inc
- Status
- Tentative approval
- FDA approval
- 16 Nov 2022
- Application
- ANDA213064-003