Composition
- Active ingredients
- BACLOFEN 20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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.
- BACLOFEN 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · Tablet, orally disintegratingNDA021589-001 · Discontinued
- BACLOFEN 20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · Tablet, orally disintegratingThis page
Official product information
Drugs@FDA lists the approved labels, letters and reviews for application NDA021589.
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
- Kemstro
- Active substance
- baclofen
- Route
- Oral
- Dosage form
- Tablet, orally disintegrating
- Applicant
- Ucb Inc
- Status
- Discontinued
- FDA approval
- 30 Oct 2003
- Application
- NDA021589-002