Phenoxybenzamine Hydrochloride

Sold as Dibenzyline. Every FDA application for this active ingredient: 1 branded and 6 generic.

As of Nov 15, 2026, FDA lists 7 applications for Phenoxybenzamine Hydrochloride (sold as Dibenzyline), first approved Jan 26, 1953, with 0 new uses approved and 0 published complete response letters.

First approved: Jan 26, 1953
Applications: 7
New uses approved: 0
Complete response letters: 0
Medicare spending, 2025: $1.6M

Medicare Spending

CMS Part D and Part B, 2025, before manufacturer rebates; matched by generic name

Product	Part	Spending, 2025	Change	Beneficiaries
Phenoxybenzamine HCl	Part D	$1.6M	-24%	90

Clinical Trials

2 open or ongoing studies name this ingredient as an intervention, including as a comparator; newest first. See all


Post-mastectomy Recovery: Comparing Preoperative PECS-II Blocks With Intraoperative Pectoral BlocksMastectomy; Lymphedema, Breast Cancer · University of Cincinnati	Phase 4	Recruiting	Aug 27, 2024
The Effect and Safety of Omitting Preoperative Alpha-adrenergic Blockade for Normotensive PheochromocytomaPheochromocytoma, Paraganglioma · Seoul National University Hospital	Phase 4	Recruiting	Jan 27, 2023

Applications

NDAs, BLAs and generic ANDAs for this ingredient, oldest first; each opens its full history


Jan 26, 1953	DibenzylineNDA 8708 · New molecular entity	Advanz Pharma	11	Discontinued
Jul 16, 2012	Phenoxybenzamine HydrochlorideANDA 201050	Hikma	0	Discontinued
Jan 24, 2017	Phenoxybenzamine HydrochlorideANDA 204522	Ph Health	0	Marketed
Oct 27, 2020	Phenoxybenzamine HydrochlorideANDA 212568	Amneal	0	Marketed
Jul 19, 2022	Phenoxybenzamine HydrochlorideANDA 215042	Novitium Pharma	0	Marketed
May 8, 2023	Phenoxybenzamine HydrochlorideANDA 215600	Aurobindo Pharma	1	Marketed
Jun 20, 2023	Phenoxybenzamine HydrochlorideANDA 204551	Rising	0	Marketed

Applications, approvals and products come from FDA's Drugs@FDA data files, refreshed weekly, grouped by active ingredient as FDA spells it. Complete response letters are FDA's published letters. Medicare spending is CMS's Part D and Part B dashboard, matched to this ingredient by generic name; shortages are FDA's shortage list, matched by application number; clinical trials are ClinicalTrials.gov studies naming the ingredient as an intervention, refreshed daily; safety programs are FDA's REMS list, matched by application number or, for shared programs, by ingredient. Drugs@FDA