Composition
- Active ingredients
- ZILEUTON 600MG
Strengths and forms
The FDA lists each strength of a product separately; these pages share one label.
- ZILEUTON 600MG · Tablet, extended releaseANDA211043-001 · Discontinued
- ZILEUTON 600MG · Tablet, extended releaseANDA211972-001 · Discontinued
- ZILEUTON 600MG · Tablet, extended releaseANDA211390-001 · Prescription
- ZILEUTON 600MG · Tablet, extended releaseThis page
- ZILEUTON 600MG · Tablet, extended releaseANDA212670-001 · Prescription
- ZILEUTON 600MG · Tablet, extended releaseANDA215742-001 · Prescription
Official product information
Drugs@FDA lists the approved labels, letters and reviews for application ANDA204929.
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
- Zileuton
- Route
- Oral
- Dosage form
- Tablet, extended release
- Applicant
- Rising
- Status
- Prescription
- FDA approval
- 17 Mar 2017
- Application
- ANDA204929-001