Composition
- Active ingredients
- ELAGOLIX 200MG
Strengths and forms
The FDA lists each strength of a product separately; these pages share one label.
- ELAGOLIX 150MG · TabletANDA217690-002 · Tentative approval
- ELAGOLIX 200MG · TabletThis page
Official product information
Drugs@FDA lists the approved labels, letters and reviews for application ANDA217642.
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
- Elagolix
- Route
- Film coated
- Dosage form
- Tablet
- Applicant
- Teva Pharms Inc
- Status
- Tentative approval
- FDA approval
- 2 Jan 2025
- Application
- ANDA217642-002