Last Updated: November 8, 2026

Details for New Drug Application (NDA): 215042

« Back to Dashboard

NDA 215042 describes PHENOXYBENZAMINE HYDROCHLORIDE, which is a drug marketed by Amneal, Aurobindo Pharma, Hikma, Novitium Pharma, Ph Health, and Rising, and is included in six NDAs. It is available from five suppliers. Additional details are available on the PHENOXYBENZAMINE HYDROCHLORIDE profile page.

The generic ingredient in PHENOXYBENZAMINE HYDROCHLORIDE is phenoxybenzamine hydrochloride. There is one drug master file entry for this compound. Five suppliers are listed for this compound. Additional details are available on the phenoxybenzamine hydrochloride profile page.

Summary for 215042

Tradename:	PHENOXYBENZAMINE HYDROCHLORIDE
Applicant:	Novitium Pharma
Ingredient:	phenoxybenzamine hydrochloride
Patents:	0

Pharmacology for NDA: 215042

Mechanism of Action	Adrenergic alpha-Antagonists

Medical Subject Heading (MeSH) Categories for 215042

Adrenergic alpha-Antagonists
Antihypertensive Agents
Vasodilator Agents

Suppliers and Packaging for NDA: 215042

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
PHENOXYBENZAMINE HYDROCHLORIDE	phenoxybenzamine hydrochloride	CAPSULE;ORAL	215042	ANDA	Novitium Pharma LLC	70954-365	70954-365-10	100 CAPSULE in 1 BOTTLE (70954-365-10)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	CAPSULE;ORAL			Strength	10MG
Approval Date:	Jul 19, 2022	TE:	AB	RLD:	No

Complete Access Available with Subscription

Make Better Decisions: Try a trial or see plans & pricing

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. We do not provide individual investment advice. This service is not registered with any financial regulatory agency. The information we publish is educational only and based on our opinions plus our models. By using DrugPatentWatch you acknowledge that we do not provide personalized recommendations or advice. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.