Composition
- Active ingredients
- HYDROMORPHONE HYDROCHLORIDE 12MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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.
- HYDROMORPHONE HYDROCHLORIDE 12MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · Tablet, extended releaseThis page
- HYDROMORPHONE HYDROCHLORIDE 16MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · Tablet, extended releaseNDA021217-003 · Discontinued
- HYDROMORPHONE HYDROCHLORIDE 8MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · Tablet, extended releaseNDA021217-001 · Discontinued
- HYDROMORPHONE HYDROCHLORIDE 32MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · Tablet, extended releaseNDA021217-004 · Discontinued
Official product information
Drugs@FDA lists the approved labels, letters and reviews for application NDA021217.
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
- Exalgo
- Active substance
- hydromorphone hydrochloride
- Route
- Oral
- Dosage form
- Tablet, extended release
- Applicant
- Specgx LLC
- Status
- Discontinued
- FDA approval
- 1 Mar 2010
- Application
- NDA021217-002