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Data updated: Mar 10, 2026

PHENTOLAMINE MESYLATE

PHENTOLAMINE MESYLATE
Approved 1998-03-11
Jump to: Indications Approvals Trials Competitors Similar Safety Patents
2
Indications
--
Phase 3 Trials
28
Years on Market

Details

Status
Prescription
First Approved
1998-03-11
Routes
INJECTION
Dosage Forms
INJECTABLE

Companies

PRECISION DOSE INC Hikma
Active Ingredient: PHENTOLAMINE MESYLATE

PHENTOLAMINE MESYLATE Approval History

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What PHENTOLAMINE MESYLATE Treats

3 indications

PHENTOLAMINE MESYLATE is approved for 3 conditions since its original approval in 1998. These indications span multiple therapeutic areas including oncology, immunology, and more.

  • Hypertension
  • Pheochromocytoma
  • Dermal Necrosis
Source: FDA Label

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Trial Timeline

ClinicalTrials.gov ↗ Pro

Full development history with FDA approval milestones

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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.

PHENTOLAMINE MESYLATE FDA Label Details

Pro

Indications & Usage

Phentolamine Mesylate for Injection, USP is indicated for the prevention or control of hypertensive episodes that may occur in a patient with pheochromocytoma as a result of stress or manipulation during preoperative preparation and surgical excision. Phentolamine Mesylate for Injection, USP is indicated for the prevention or treatment of dermal necrosis and sloughing following intravenous administration or extravasation of norepinephrine. Phentolamine Mesylate for Injection, USP is also indicated for the diagnosis of pheochromocytoma by the Phentolamine Mesylate for Injection, USP blocking te...

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Data Sources

FDA Approval: ANDA207686 → Label: DailyMed → Trials: ClinicalTrials.gov →

Data sourced from official FDA and NIH databases. Click links to verify on original sources.