Composition
- Active ingredients
- FIDAXOMICIN 200MG
Strengths and forms
The FDA lists each strength of a product separately; these pages share one label.
- FIDAXOMICIN 200MG · TabletThis page
- FIDAXOMICIN 200MG · TabletANDA219559-001 · Prescription
- FIDAXOMICIN 200MG · TabletANDA220374-001 · Prescription
Official product information
Drugs@FDA lists the approved labels, letters and reviews for application ANDA208443.
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
- Fidaxomicin
- Route
- Oral
- Dosage form
- Tablet
- Applicant
- Actavis Labs FL
- Status
- Prescription
- FDA approval
- 16 Jan 2024
- Application
- ANDA208443-001