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Generated: August 22, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 079090

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NDA 079090 describes CLONIDINE, which is a drug marketed by Tris Pharma Inc, Aveva, Mylan Technologies, Actavis Labs Ut Inc, Mayne Pharma, Hikma Farmaceutica, Zydus Pharms Usa Inc, Duramed Pharms Barr, Prinston Inc, Teva, Luitpold, Mylan, Actavis Elizabeth, Frontida Biopharm, Sun Pharm Inds Inc, Warner Chilcott, Interpharm, Par Pharm, Watson Labs, Exela Pharma Scs Llc, Alembic Pharms Ltd, Fresenius Kabi Usa, Am Therap, Anchen Pharms, Chartwell Molecules, Aurolife Pharma Llc, Unichem, Yung Shin Pharm, and Impax Labs, and is included in sixty-one 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 fifteen 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 NDA: 079090

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

Pharmacology for NDA: 079090

Mechanism of ActionAdrenergic alpha2-Agonists

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 Teva Pharmaceuticals USA, Inc. 0555-1009 0555-1009-16 4 POUCH in 1 CARTON (0555-1009-16) > 1 PATCH in 1 POUCH (0555-1009-01) > 24 h in 1 PATCH
CLONIDINE
clonidine
FILM, EXTENDED RELEASE;TRANSDERMAL 079090 ANDA Teva Pharmaceuticals USA, Inc. 0555-1010 0555-1010-16 4 POUCH in 1 CARTON (0555-1010-16) > 1 PATCH in 1 POUCH (0555-1010-01) > 24 h in 1 PATCH

Summary for product number 001

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

Summary for product number 002

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

Summary 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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Serving 500+ biopharmaceutical companies globally:

McKinsey
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Harvard Business School
McKesson
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QuintilesIMS
Cipla
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Cantor Fitzgerald

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