Composition
- Active ingredients
- OBETICHOLIC ACID 5MG
Strengths and forms
The FDA lists each strength of a product separately; these pages share one label.
- OBETICHOLIC ACID 10MG · TabletNDA207999-002 · Discontinued
- OBETICHOLIC ACID 5MG · TabletThis page
Official product information
Drugs@FDA lists the approved labels, letters and reviews for application NDA207999.
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
- Ocaliva
- Active substance
- obeticholic acid
- Route
- Oral
- Dosage form
- Tablet
- Applicant
- Intercept
- Status
- Discontinued
- FDA approval
- 27 May 2016
- Application
- NDA207999-001