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Serving 500+ biopharmaceutical companies globally:

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Generated: June 23, 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 Twi Pharms Inc, Amneal Pharm, Impax Labs Inc, Watson Labs, Sandoz Inc, Epic Pharma Llc, Mylan Pharms Inc, Actavis Elizabeth, Teva Pharms Usa, and Mylan, and is included in eleven NDAs. It is available from twenty-two 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-four suppliers are listed for this compound. Additional details are available on the guanfacine hydrochloride profile page.

Summary for NDA: 074673

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

Pharmacology for NDA: 074673

Mechanism of ActionAdrenergic alpha2-Agonists

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 500+ biopharmaceutical companies globally:

Teva
AstraZeneca
Medtronic
Baxter
Citi
Julphar
Express Scripts
Cerilliant
Boehringer Ingelheim
QuintilesIMS

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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