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Serving hundreds of leading biopharmaceutical companies globally:

Harvard Business School
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US Department of Justice
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Generated: March 24, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 008708

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NDA 008708 describes DIBENZYLINE, which is a drug marketed by Concordia Pharms Inc and is included in one NDA. It is available from two suppliers. Additional details are available on the DIBENZYLINE profile page.

The generic ingredient in DIBENZYLINE is phenoxybenzamine hydrochloride. There are five drug master file entries for this compound. Four suppliers are listed for this compound. Additional details are available on the phenoxybenzamine hydrochloride profile page.
Summary for 008708
Applicant:Concordia Pharms Inc
Ingredient:phenoxybenzamine hydrochloride
Therapeutic Class:Cardiovascular Agents
Formulation / Manufacturing:see details
Pharmacology for NDA: 008708
Mechanism of ActionAdrenergic alpha-Antagonists
Medical Subject Heading (MeSH) Categories for 008708
Suppliers and Packaging for NDA: 008708
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
DIBENZYLINE phenoxybenzamine hydrochloride CAPSULE;ORAL 008708 NDA Concordia Pharmaceuticals Inc. 59212-001 N 59212-001-01
DIBENZYLINE phenoxybenzamine hydrochloride CAPSULE;ORAL 008708 NDA AUTHORIZED GENERIC Prasco Laboratories 66993-066 N 66993-066-02

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength10MG
Approval Date:Approved Prior to Jan 1, 1982TE:ABRLD:Yes

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Serving hundreds of leading biopharmaceutical companies globally:

Farmers Insurance
US Department of Justice
Express Scripts

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