Composition
- Active ingredients
- CENOBAMATE 100MG
Strengths and forms
The FDA lists each strength of a product separately; these pages share one label.
- CENOBAMATE 12.5MG · TabletANDA219403-006 · Tentative approval
- CENOBAMATE 100MG · TabletANDA219403-004 · Tentative approval
- CENOBAMATE 50MG · TabletANDA219403-002 · Tentative approval
- CENOBAMATE 25MG · TabletANDA219403-005 · Tentative approval
- CENOBAMATE 200MG · TabletANDA219403-003 · Tentative approval
- CENOBAMATE 100MG · TabletThis page
- CENOBAMATE 50MG · TabletANDA219473-002 · Tentative approval
- CENOBAMATE 25MG · TabletANDA219473-005 · Tentative approval
- CENOBAMATE 200MG · TabletANDA219473-003 · Tentative approval
- CENOBAMATE 12.5MG · TabletANDA219473-006 · Tentative approval
Official product information
Drugs@FDA lists the approved labels, letters and reviews for application ANDA219473.
At a glance
- Brand name
- Cenobamate
- Dosage form
- Tablet
- Applicant
- Aurobindo Pharma Limited
- Status
- Tentative approval
- FDA approval
- 28 Apr 2026
- Application
- ANDA219473-004