Composition
- Active ingredients
- ELUXADOLINE 100MG
Strengths and forms
The FDA lists each strength of a product separately; these pages share one label.
- ELUXADOLINE 100MG · TabletANDA213511-002 · Prescription
- ELUXADOLINE 75MG · TabletANDA213511-001 · Prescription
- ELUXADOLINE 75MG · TabletANDA213522-001 · Discontinued
- ELUXADOLINE 100MG · TabletThis page
- ELUXADOLINE 100MG · TabletANDA213576-002 · Tentative approval
- ELUXADOLINE 75MG · TabletANDA213576-001 · Tentative approval
- ELUXADOLINE 75MG · TabletANDA213613-001 · Prescription
- ELUXADOLINE 100MG · TabletANDA213613-002 · Prescription
Official product information
Drugs@FDA lists the approved labels, letters and reviews for application ANDA213522.
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
- Eluxadoline
- Route
- Oral
- Dosage form
- Tablet
- Applicant
- Zydus Pharms
- Status
- Discontinued
- FDA approval
- 14 Mar 2025
- Application
- ANDA213522-002