Anti-gonadotropin-releasing hormones
Elagolix
The FDA lists this product in 2 strengths and forms.
Composition
- Active ingredients
- ELAGOLIX 150MG
Strengths and forms
The FDA lists each strength of a product separately; these pages share one label.
- ELAGOLIX 150MG · TabletThis page
- ELAGOLIX 200MG · TabletANDA217642-002 · Tentative approval
Official product information
Drugs@FDA lists the approved labels, letters and reviews for application ANDA217690.
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
- Drug class
- Anti-gonadotropin-releasing hormones
- Dosage form
- Tablet
- Applicant
- Hetero Labs Limited
- Status
- Tentative approval
- FDA approval
- 1 Jul 2025
- Application
- ANDA217690-002
- RxCUI
- 2049846