Details for New Drug Application (NDA): 019032

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NDA 019032 describes TENEX, which is a drug marketed by Promius Pharma and is included in one NDA. Additional details are available on the TENEX profile page.

The generic ingredient in TENEX is guanfacine hydrochloride. There are seven drug master file entries for this compound. Thirty-four suppliers are listed for this compound. Additional details are available on the guanfacine hydrochloride profile page.

Summary for 019032

Tradename:	TENEX
Applicant:	Promius Pharma
Ingredient:	guanfacine hydrochloride
Patents:	0

Medical Subject Heading (MeSH) Categories for 019032

Adrenergic alpha-2 Receptor Agonists
Antihypertensive Agents

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	EQ 1MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons
Approval Date:	Oct 27, 1986	TE:		RLD:	Yes

Profile for product number 002

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	EQ 2MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons
Approval Date:	Nov 7, 1988	TE:		RLD:	Yes

Profile for product number 003

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	EQ 3MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons
Approval Date:	Nov 7, 1988	TE:		RLD:	No

Expired US Patents for NDA 019032

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Promius Pharma	TENEX	guanfacine hydrochloride	TABLET;ORAL	019032-001	Oct 27, 1986	3,632,645	⤷ Subscribe
Promius Pharma	TENEX	guanfacine hydrochloride	TABLET;ORAL	019032-003	Nov 7, 1988	3,632,645	⤷ Subscribe
Promius Pharma	TENEX	guanfacine hydrochloride	TABLET;ORAL	019032-002	Nov 7, 1988	3,632,645	⤷ Subscribe
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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