DIBENZYLINE (phenoxybenzamine hydrochloride) · ADVANZ PHARMA
DIBENZYLINE is FDA-approved to treat 2 conditions (same as PHENOXYBENZAMINE HYDROCHLORIDE).
Details
- Status
- Discontinued
- First Approved
- 1953-01-26
- Routes
- ORAL
- Dosage Forms
- CAPSULE
DIBENZYLINE Approval History
What DIBENZYLINE Treats
2 indicationsDIBENZYLINE is approved for 2 conditions since its original approval in 1953. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Pheochromocytoma
- Hypertension
Same approved indications as PHENOXYBENZAMINE HYDROCHLORIDE (same active ingredient).
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.
DIBENZYLINE FDA Label Details
Indications & Usage
FDA Label (PDF)DIBENZYLINE is FDA-approved to treat 2 conditions — same approved indications as PHENOXYBENZAMINE HYDROCHLORIDE.
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.