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. 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. Six suppliers are listed for this compound. Additional details are available on the acebutolol hydrochloride profile page.

Summary for 018917

Tradename:	SECTRAL
Applicant:	Promius Pharma
Ingredient:	acebutolol hydrochloride
Patents:	0

Medical Subject Heading (MeSH) Categories for 018917

Adrenergic beta-1 Receptor Antagonists
Anti-Arrhythmia Agents
Antihypertensive Agents
Sympathomimetics

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	CAPSULE;ORAL			Strength	EQ 200MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons
Approval Date:	Dec 28, 1984	TE:		RLD:	Yes

Profile for product number 003

Active Rx/OTC/Discontinued:	DISCN	Dosage:	CAPSULE;ORAL			Strength	EQ 400MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons
Approval Date:	Dec 28, 1984	TE:		RLD:	Yes

Expired US 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;ORAL	018917-001	Dec 28, 1984	⤷ Subscribe	⤷ Subscribe
Promius Pharma	SECTRAL	acebutolol hydrochloride	CAPSULE;ORAL	018917-003	Dec 28, 1984	⤷ Subscribe	⤷ Subscribe
Promius Pharma	SECTRAL	acebutolol hydrochloride	CAPSULE;ORAL	018917-003	Dec 28, 1984	⤷ Subscribe	⤷ Subscribe
Promius Pharma	SECTRAL	acebutolol hydrochloride	CAPSULE;ORAL	018917-001	Dec 28, 1984	⤷ Subscribe	⤷ Subscribe
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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