FDA
Viloxazine Hydrochloride
The FDA lists this product in 2 strengths and forms.
Composition
- Active ingredients
- VILOXAZINE HYDROCHLORIDE 200MG
Strengths and forms
The FDA lists each strength of a product separately; these pages share one label.
- VILOXAZINE HYDROCHLORIDE 150MG · Capsule, extended releaseANDA220326-003 · Tentative approval
- VILOXAZINE HYDROCHLORIDE 200MG · Capsule, extended releaseThis page
Official product information
Drugs@FDA lists the approved labels, letters and reviews for application ANDA220326.
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
- Viloxazine Hydrochloride
- Dosage form
- Capsule, extended release
- Applicant
- Appco Pharma LLC
- Status
- Tentative approval
- FDA approval
- 28 Apr 2026
- Application
- ANDA220326-002