Composition
- Active ingredients
- CYCLOBENZAPRINE HYDROCHLORIDE 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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.
- CYCLOBENZAPRINE HYDROCHLORIDE 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TabletNDA017821-001 · Discontinued
- CYCLOBENZAPRINE HYDROCHLORIDE 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TabletThis page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 NDA017821.
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
- Flexeril
- Active substance
- cyclobenzaprine hydrochloride
- Route
- Oral
- Dosage form
- Tablet
- Applicant
- Janssen Res and Dev
- Status
- Discontinued
- FDA approval
- 26 Aug 1977
- Application
- NDA017821-002