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Generated: December 15, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 076166

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NDA 076166 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, Anchen Pharms, Lupin Ltd, 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 NDAs. It is available from seven suppliers. Additional details are available on the CLONIDINE profile page.

The generic ingredient in CLONIDINE is chlorthalidone; clonidine hydrochloride. There are sixteen drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the chlorthalidone; clonidine hydrochloride profile page.

Summary for 076166

Tradename:1
Applicant:1
Ingredient:1
Patents:0
Formulation / Manufacturing:see details

Pharmacology for NDA: 076166

Mechanism of ActionAdrenergic alpha2-Agonists

Suppliers and Packaging for NDA: 076166

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
CLONIDINE clonidine FILM, EXTENDED RELEASE;TRANSDERMAL 076166 ANDA Mylan Pharmaceuticals Inc. 0378-0871 0378-0871-99 4 POUCH in 1 CARTON (0378-0871-99) > 1 PATCH in 1 POUCH (0378-0871-16) > 7 d in 1 PATCH
CLONIDINE clonidine FILM, EXTENDED RELEASE;TRANSDERMAL 076166 ANDA Mylan Pharmaceuticals Inc. 0378-0872 0378-0872-99 4 POUCH in 1 CARTON (0378-0872-99) > 1 PATCH in 1 POUCH (0378-0872-16) > 7 d in 1 PATCH

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:FILM, EXTENDED RELEASE;TRANSDERMALStrength0.1MG/24HR
Approval Date:Jul 16, 2010TE:ABRLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:FILM, EXTENDED RELEASE;TRANSDERMALStrength0.2MG/24HR
Approval Date:Jul 16, 2010TE:ABRLD:No

Summary for product number 003

Active Rx/OTC/Discontinued:RXDosage:FILM, EXTENDED RELEASE;TRANSDERMALStrength0.3MG/24HR
Approval Date:Jul 16, 2010TE:ABRLD:No


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Serving leading biopharmaceutical companies globally:

Colorcon
US Army
Daiichi Sankyo
Harvard Business School
Healthtrust
AstraZeneca
Cipla
Dow
Medtronic
Cantor Fitzgerald

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