Upgrade to enjoy subscriber-only features like email alerts and data export. See the Plans and Pricing

Serving hundreds of leading biopharmaceutical companies globally:

Federal Trade Commission
Boehringer Ingelheim
Daiichi Sankyo
Express Scripts
Mallinckrodt
US Department of Justice
Cantor Fitzgerald
Teva
QuintilesIMS

Generated: June 19, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 074145

« Back to Dashboard

NDA 074145 describes GUANFACINE HYDROCHLORIDE, which is a drug marketed by Actavis Elizabeth, Impax Labs Inc, Mylan Pharms Inc, Sandoz Inc, Sun Pharm Inds Ltd, Teva Pharms Usa, Twi Pharms Inc, Amneal Pharm, Epic Pharma Llc, Mylan, and Watson Labs, and is included in twelve NDAs. It is available from twenty-three suppliers. Additional details are available on the GUANFACINE HYDROCHLORIDE profile page.

The generic ingredient in GUANFACINE HYDROCHLORIDE 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 074145
Tradename:GUANFACINE HYDROCHLORIDE
Applicant:Watson Labs
Ingredient:guanfacine hydrochloride
Patents:0
Therapeutic Class:Cardiovascular Agents
Pharmacology for NDA: 074145
Mechanism of ActionAdrenergic alpha2-Agonists
Medical Subject Heading (MeSH) Categories for 074145
Suppliers and Packaging for NDA: 074145
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
GUANFACINE HYDROCHLORIDE guanfacine hydrochloride TABLET;ORAL 074145 ANDA Actavis Pharma, Inc. 0591-0444 N 0591-0444-01
GUANFACINE HYDROCHLORIDE guanfacine hydrochloride TABLET;ORAL 074145 ANDA Actavis Pharma, Inc. 0591-0453 N 0591-0453-01

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 1MG BASE
Approval Date:Oct 17, 1995TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 2MG BASE
Approval Date:Oct 17, 1995TE:ABRLD:No

Complete Access Available with Subscription

For more information try a trial or see the plans and pricing

Serving hundreds of leading biopharmaceutical companies globally:

McKinsey
Deloitte
Argus Health
Chinese Patent Office
Daiichi Sankyo
QuintilesIMS
Covington
Express Scripts
Queensland Health

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.