Composition
- Active ingredients
- VALBENAZINE 80MG
Strengths and forms
The FDA lists each strength of a product separately; these pages share one label.
- VALBENAZINE 40MG · CapsuleANDA215962-001 · Tentative approval
- VALBENAZINE 80MG · CapsuleThis page
Official product information
Drugs@FDA lists the approved labels, letters and reviews for application ANDA215962.
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
- Valbenazine
- Route
- Oral
- Dosage form
- Capsule
- Applicant
- Sandoz Inc
- Status
- Tentative approval
- FDA approval
- 12 Dec 2022
- Application
- ANDA215962-002