Composition
- Active ingredients
- OXYBUTYNIN CHLORIDE 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Strengths and forms
The FDA lists each strength of a product separately; these pages share one label.
- OXYBUTYNIN CHLORIDE 15MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · Tablet, extended releaseNDA020897-003 · Discontinued
- OXYBUTYNIN CHLORIDE 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · Tablet, extended releaseThis page
- OXYBUTYNIN CHLORIDE 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · Tablet, extended releaseNDA020897-002 · Discontinued
Official product information
Drugs@FDA lists the approved labels, letters and reviews for application NDA020897.
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
- Ditropan XL
- Active substance
- oxybutynin chloride
- Route
- Oral
- Dosage form
- Tablet, extended release
- Applicant
- Janssen Pharms
- Status
- Discontinued
- FDA approval
- 16 Dec 1998
- Application
- NDA020897-001