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BioPharmaceutical Business Intelligence

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Serving leading biopharmaceutical companies globally:

UBS
Boehringer Ingelheim
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Deloitte
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Generated: December 12, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 076157

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NDA 076157 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 076157

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

Pharmacology for NDA: 076157

Mechanism of ActionAdrenergic alpha2-Agonists

Suppliers and Packaging for NDA: 076157

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
CLONIDINE clonidine FILM, EXTENDED RELEASE;TRANSDERMAL 076157 ANDA Physicians Total Care, Inc. 54868-6214 54868-6214-0 4 POUCH in 1 CARTON (54868-6214-0) > 1 PATCH in 1 POUCH > 7 d in 1 PATCH
CLONIDINE clonidine FILM, EXTENDED RELEASE;TRANSDERMAL 076157 ANDA Physicians Total Care, Inc. 54868-6260 54868-6260-0 4 POUCH in 1 CARTON (54868-6260-0) > 1 PATCH in 1 POUCH > 7 d in 1 PATCH

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:FILM, EXTENDED RELEASE;TRANSDERMALStrength0.1MG/24HR
Approval Date:Aug 18, 2009TE:ABRLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:FILM, EXTENDED RELEASE;TRANSDERMALStrength0.2MG/24HR
Approval Date:Aug 18, 2009TE:ABRLD:No

Summary for product number 003

Active Rx/OTC/Discontinued:RXDosage:FILM, EXTENDED RELEASE;TRANSDERMALStrength0.3MG/24HR
Approval Date:Aug 18, 2009TE:ABRLD:No


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Serving leading biopharmaceutical companies globally:

Deloitte
Harvard Business School
US Army
Accenture
Cantor Fitzgerald
Medtronic
Teva
Healthtrust
McKesson
AstraZeneca

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