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Generated: February 23, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 202578

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NDA 202578 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 202578
Tradename:GUANFACINE HYDROCHLORIDE
Applicant:Mylan Pharms Inc
Ingredient:guanfacine hydrochloride
Patents:0
Therapeutic Class:Cardiovascular Agents
Pharmacology for NDA: 202578
Mechanism of ActionAdrenergic alpha2-Agonists
Medical Subject Heading (MeSH) Categories for 202578
Suppliers and Packaging for NDA: 202578
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
GUANFACINE HYDROCHLORIDE guanfacine hydrochloride TABLET, EXTENDED RELEASE;ORAL 202578 ANDA Mylan Pharmaceuticals Inc. 0378-1061 N 0378-1061-01
GUANFACINE HYDROCHLORIDE guanfacine hydrochloride TABLET, EXTENDED RELEASE;ORAL 202578 ANDA Mylan Pharmaceuticals Inc. 0378-1062 N 0378-1062-01

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrengthEQ 1MG BASE
Approval Date:Jun 2, 2015TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrengthEQ 2MG BASE
Approval Date:Jun 2, 2015TE:ABRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrengthEQ 3MG BASE
Approval Date:Jun 2, 2015TE:ABRLD:No

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