Composition
- Active ingredients
- NALOXEGOL 12.5MG
Strengths and forms
The FDA lists each strength of a product separately; these pages share one label.
- NALOXEGOL 25MG · TabletANDA212625-002 · Tentative approval
- NALOXEGOL 12.5MG · TabletThis page
Official product information
Drugs@FDA lists the approved labels, letters and reviews for application ANDA212625.
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
- Naloxegol
- Route
- Oral
- Dosage form
- Tablet
- Applicant
- MSN Labs PVT LTD
- Status
- Tentative approval
- FDA approval
- 24 Feb 2021
- Application
- ANDA212625-001