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Serving leading biopharmaceutical companies globally:

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Generated: December 16, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 074673

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NDA 074673 describes GUANFACINE HYDROCHLORIDE, which is a drug marketed by Actavis Elizabeth, Impax Labs Inc, Mylan Pharms Inc, Sandoz Inc, Teva Pharms Usa, Twi Pharms Inc, Amneal Pharm, Epic Pharma Llc, Mylan, and Watson Labs, and is included in eleven 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 074673

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

Pharmacology for NDA: 074673

Mechanism of ActionAdrenergic alpha2-Agonists

Medical Subject Heading (MeSH) Categories for 074673

Suppliers and Packaging for NDA: 074673

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
GUANFACINE HYDROCHLORIDE guanfacine hydrochloride TABLET;ORAL 074673 ANDA PuraCap Laboratories, LLC 24658-730 24658-730-01 100 TABLET in 1 BOTTLE (24658-730-01)
GUANFACINE HYDROCHLORIDE guanfacine hydrochloride TABLET;ORAL 074673 ANDA PuraCap Laboratories, LLC 24658-731 24658-731-01 100 TABLET in 1 BOTTLE (24658-731-01)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 1MG BASE
Approval Date:Feb 28, 1997TE:ABRLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 2MG BASE
Approval Date:Feb 28, 1997TE:ABRLD:No


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Serving leading biopharmaceutical companies globally:

Merck
Colorcon
Julphar
Farmers Insurance
Harvard Business School
Chinese Patent Office
Fish and Richardson
Cerilliant
QuintilesIMS
Johnson and Johnson

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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