Composition
- Active ingredients
- FIDAXOMICIN 40MG/ML
Strengths and forms
The FDA lists each strength of a product separately; these pages share one label.
- FIDAXOMICIN 200MG · TabletNDA201699-001 · Prescription
- FIDAXOMICIN 40MG/ML · For suspensionThis page
Official product information
Drugs@FDA lists the approved labels, letters and reviews for application NDA213138.
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
- Dificid
- Active substance
- fidaxomicin
- Route
- Oral
- Dosage form
- For suspension
- Applicant
- Cubist Pharms LLC
- Status
- Prescription
- FDA approval
- 24 Jan 2020
- Application
- NDA213138-001