Bile acids and derivatives
Obeticholic Acid
The FDA lists this product in 7 strengths and forms.
Composition
- Active ingredients
- OBETICHOLIC ACID 10MG
Strengths and forms
The FDA lists each strength of a product separately; these pages share one label.
- OBETICHOLIC ACID 10mg · TabletANDA214935-002 · Tentative approval
- OBETICHOLIC ACID 5MG · TabletANDA214862-001 · Discontinued
- OBETICHOLIC ACID 10MG · TabletANDA214862-002 · Discontinued
- OBETICHOLIC ACID 5MG · TabletANDA214980-001 · Discontinued
- OBETICHOLIC ACID 10MG · TabletThis page
- OBETICHOLIC ACID 10MG · TabletANDA215017-002 · Discontinued
- OBETICHOLIC ACID 5MG · TabletANDA215017-001 · Discontinued
Official product information
Drugs@FDA lists the approved labels, letters and reviews for application ANDA214980.
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
- Obeticholic Acid
- Drug class
- Bile acids and derivatives
- Route
- Oral
- Dosage form
- Tablet
- Applicant
- Lupin
- Status
- Discontinued
- FDA approval
- 30 May 2023
- Application
- ANDA214980-002
- RxCUI
- 1798288