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Details for New Drug Application (NDA): 076157

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NDA 076157 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, Vintage, 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, Dava Pharms Inc, Aurolife Pharma Llc, Unichem, Carlsbad, and Impax Labs, and is included in sixty-one NDAs. It is available from six 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: 076157

Tradename:
CLONIDINE
Applicant:
Aveva
Ingredient:
clonidine
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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