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Generated: February 21, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 075109

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NDA 075109 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 075109
Applicant:Amneal Pharm
Ingredient:guanfacine hydrochloride
Therapeutic Class:Cardiovascular Agents
Pharmacology for NDA: 075109
Mechanism of ActionAdrenergic alpha2-Agonists
Medical Subject Heading (MeSH) Categories for 075109
Suppliers and Packaging for NDA: 075109
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
GUANFACINE HYDROCHLORIDE guanfacine hydrochloride TABLET;ORAL 075109 ANDA Major Pharmaceuticals 0904-6183 N 0904-6183-60
GUANFACINE HYDROCHLORIDE guanfacine hydrochloride TABLET;ORAL 075109 ANDA Major Pharmaceuticals 0904-6184 N 0904-6184-60

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 1MG BASE
Approval Date:Nov 25, 1998TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 2MG BASE
Approval Date:Nov 25, 1998TE:ABRLD:No

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