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Generated: May 22, 2018

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, 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 074673
Tradename:GUANFACINE HYDROCHLORIDE
Applicant:Epic Pharma Llc
Ingredient:guanfacine hydrochloride
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 dba Blu Pharmaceuticals 24658-730 N 24658-730-01
GUANFACINE HYDROCHLORIDE guanfacine hydrochloride TABLET;ORAL 074673 ANDA PuraCap Laboratories LLC dba Blu Pharmaceuticals 24658-731 N 24658-731-01

Profile for product number 001

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

Profile 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 hundreds of leading biopharmaceutical companies globally:

Cipla
Boehringer Ingelheim
Daiichi Sankyo
Healthtrust
Johnson and Johnson
Merck
Cerilliant
Covington
Deloitte

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