Composition
- Active ingredients
- TRAMADOL HYDROCHLORIDE 50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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.
- TRAMADOL HYDROCHLORIDE 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TabletNDA020281-001 · Discontinued
- TRAMADOL HYDROCHLORIDE 50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TabletThis page
Official product information
Drugs@FDA lists the approved labels, letters and reviews for application NDA020281.
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
- Ultram
- Active substance
- tramadol hydrochloride
- Route
- Oral
- Dosage form
- Tablet
- Applicant
- Janssen Pharms
- Status
- Discontinued
- FDA approval
- 3 Mar 1995
- Application
- NDA020281-002