NALTREXONE HYDROCHLORIDE
Details
- Status
- Prescription
- First Approved
- 1998-05-08
- Routes
- ORAL
- Dosage Forms
- TABLET
NALTREXONE HYDROCHLORIDE Approval History
What NALTREXONE HYDROCHLORIDE Treats
1 indicationsNALTREXONE HYDROCHLORIDE is approved for 1 conditions since its original approval in 1998. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Alcohol Dependence
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Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
NALTREXONE HYDROCHLORIDE FDA Label Details
ProIndications & Usage
FDA Label (PDF)Naltrexone hydrochloride tablets USP 50 mg is indicated in the treatment of alcohol dependence and for the blockade of the effects of exogenously administered opioids. Naltrexone hydrochloride tablets USP 50 mg has not been shown to provide any therapeutic benefit except as part of an appropriate plan of management for the addictions.
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.