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.
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
| Tradename: | DIBENZYLINE |
| Applicant: | Concordia |
| Ingredient: | phenoxybenzamine hydrochloride |
| Patents: | 0 |
Pharmacology for NDA: 008708
| Mechanism of Action | Adrenergic 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: | RX | Dosage: | CAPSULE;ORAL | Strength | 10MG | ||||
| Approval Date: | Approved Prior to Jan 1, 1982 | TE: | AB | RLD: | Yes | ||||
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