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Generated: May 24, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 079090

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NDA 079090 describes CLONIDINE, which is a drug marketed by Actavis Labs Ut Inc, Aveva, Mayne Pharma, Mylan Technologies, Tris Pharma Inc, Exela Pharma Scs Llc, Fresenius Kabi Usa, Hikma Farmaceutica, Luitpold, Zydus Pharms Usa Inc, Actavis Elizabeth, Ajanta Pharma Ltd, Amneal Pharms Ny, Anchen Pharms, Jubilant Generics, Lupin Ltd, Mayne Pharma Inc, Xiamen Lp Pharm Co, Alembic Pharms Ltd, Am Therap, Aurolife Pharma Llc, Chartwell Molecules, Duramed Pharms Barr, Frontida Biopharm, Impax Labs, Interpharm, Mylan, Par Pharm, Prinston Inc, Sun Pharm Inds Inc, Teva, Unichem, Warner Chilcott, Watson Labs, and Yung Shin Pharm, and is included in sixty-three NDAs. It is available from five suppliers. Additional details are available on the CLONIDINE profile page.

The generic ingredient in CLONIDINE is chlorthalidone; clonidine hydrochloride. There are nineteen drug master file entries for this compound. Additional details are available on the chlorthalidone; clonidine hydrochloride profile page.
Summary for 079090
Tradename:CLONIDINE
Applicant:Mayne Pharma
Ingredient:clonidine
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 079090
Mechanism of ActionAdrenergic alpha2-Agonists
Medical Subject Heading (MeSH) Categories for 079090
Suppliers and Packaging for NDA: 079090
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
CLONIDINE clonidine FILM, EXTENDED RELEASE;TRANSDERMAL 079090 ANDA Mayne Pharma Inc. 51862-453 N 51862-453-04
CLONIDINE clonidine FILM, EXTENDED RELEASE;TRANSDERMAL 079090 ANDA Mayne Pharma Inc. 51862-454 N 51862-454-04

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:FILM, EXTENDED RELEASE;TRANSDERMALStrength0.1MG/24HR
Approval Date:Aug 20, 2010TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:FILM, EXTENDED RELEASE;TRANSDERMALStrength0.2MG/24HR
Approval Date:Aug 20, 2010TE:ABRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:FILM, EXTENDED RELEASE;TRANSDERMALStrength0.3MG/24HR
Approval Date:Aug 20, 2010TE:ABRLD:No

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