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Last Updated: June 13, 2024

Details for New Drug Application (NDA): 008708

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NDA 008708 describes DIBENZYLINE, which is a drug marketed by Concordia 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 seven drug master file entries for this compound. Seven suppliers are listed for this compound. Additional details are available on the phenoxybenzamine hydrochloride profile page.
Summary for 008708
Ingredient:phenoxybenzamine hydrochloride
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 Concordia Pharmaceuticals Inc. 59212-001 59212-001-02 100 CAPSULE in 1 BOTTLE (59212-001-02)

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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