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Serving 500+ biopharmaceutical companies globally:

McKinsey
Argus Health
Citi
Mallinckrodt
Novartis
Cerilliant
Deloitte
Johnson and Johnson
Daiichi Sankyo
Accenture

Generated: August 21, 2017

DrugPatentWatch Database Preview

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. It is available from one supplier. 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. Twenty-five suppliers are listed for this compound. Additional details are available on the guanfacine hydrochloride profile page.

Summary for NDA: 019032

Tradename:
1
Applicant:
1
Ingredient:
1
Patents:0
Therapeutic Class:Cardiovascular Agents

Pharmacology for NDA: 019032

Mechanism of ActionAdrenergic alpha2-Agonists

Suppliers and Packaging for NDA: 019032

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
TENEX
guanfacine hydrochloride
TABLET;ORAL 019032 NDA Promius Pharma, LLC 67857-705 67857-705-01 100 TABLET in 1 BOTTLE, PLASTIC (67857-705-01)
TENEX
guanfacine hydrochloride
TABLET;ORAL 019032 NDA Promius Pharma, LLC 67857-705 67857-705-05 500 TABLET in 1 BOTTLE, PLASTIC (67857-705-05)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 1MG BASE
Approval Date:Oct 27, 1986TE:ABRLD:Yes

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 2MG BASE
Approval Date:Nov 7, 1988TE:ABRLD:Yes

Summary for product number 003

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrengthEQ 3MG BASE
Approval Date:Nov 7, 1988TE:RLD:No

Expired Orange Book Patents for NDA: 019032

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Promius Pharma
TENEX
guanfacine hydrochloride
TABLET;ORAL019032-001Oct 27, 1986► Subscribe► Subscribe
Promius Pharma
TENEX
guanfacine hydrochloride
TABLET;ORAL019032-003Nov 7, 1988► Subscribe► Subscribe
Promius Pharma
TENEX
guanfacine hydrochloride
TABLET;ORAL019032-002Nov 7, 1988► Subscribe► Subscribe
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Serving 500+ biopharmaceutical companies globally:

McKinsey
AstraZeneca
Harvard Business School
Merck
Argus Health
Fish and Richardson
Chinese Patent Office
US Army
Novartis
UBS

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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