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Details for New Drug Application (NDA): 018917

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NDA 018917 describes SECTRAL, which is a drug marketed by Promius Pharma and is included in one NDA. It is available from one supplier. Additional details are available on the SECTRAL profile page.

The generic ingredient in SECTRAL is acebutolol hydrochloride. There are nine drug master file entries for this compound. Eight suppliers are listed for this compound. Additional details are available on the acebutolol hydrochloride profile page.

Summary for NDA: 018917

Tradename:
SECTRAL
Applicant:
Promius Pharma
Ingredient:
acebutolol hydrochloride
Patents:0
Therapeutic Class:Cardiovascular Agents
Formulation / Manufacturing:see details

Pharmacology for NDA: 018917

Mechanism of ActionAdrenergic beta-Antagonists

Suppliers and Packaging for NDA: 018917

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
SECTRAL
acebutolol hydrochloride
CAPSULE;ORAL 018917 NDA Promius Pharma, LLC 67857-700 67857-700-01 100 CAPSULE in 1 BOTTLE, PLASTIC (67857-700-01)
SECTRAL
acebutolol hydrochloride
CAPSULE;ORAL 018917 NDA Promius Pharma, LLC 67857-701 67857-701-01 100 CAPSULE in 1 BOTTLE, PLASTIC (67857-701-01)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrengthEQ 200MG BASE
Approval Date:Dec 28, 1984TE:ABRLD:No

Summary for product number 003

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrengthEQ 400MG BASE
Approval Date:Dec 28, 1984TE:ABRLD:Yes

Expired Orange Book Patents for NDA: 018917

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Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Promius Pharma
SECTRAL
acebutolol hydrochloride
CAPSULE;ORAL018917-001Dec 28, 19843,726,919► subscribe
Promius Pharma
SECTRAL
acebutolol hydrochloride
CAPSULE;ORAL018917-003Dec 28, 19843,857,952► subscribe
Promius Pharma
SECTRAL
acebutolol hydrochloride
CAPSULE;ORAL018917-003Dec 28, 19843,726,919► subscribe
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