BioPharmaceutical Business Intelligence

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Serving leading biopharmaceutical companies globally:

US Department of Justice

Generated: December 15, 2017

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 four 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

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 59212-001-01 100 CAPSULE in 1 BOTTLE (59212-001-01)
DIBENZYLINE phenoxybenzamine hydrochloride CAPSULE;ORAL 008708 NDA AUTHORIZED GENERIC Prasco Laboratories 66993-066 66993-066-02 100 CAPSULE in 1 BOTTLE (66993-066-02)

Summary 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 leading biopharmaceutical companies globally:

Federal Trade Commission
Express Scripts

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