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Last Updated: December 15, 2025

Details for New Drug Application (NDA): 076157

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NDA 076157 describes CLONIDINE, which is a drug marketed by Tris Pharma Inc, Actavis Labs Ut Inc, Dr Reddys Labs Sa, Ingenus Pharms Llc, Mylan Technologies, Am Regent, Fresenius Kabi Usa, Hikma Farmaceutica, Xgen Pharms, Zydus Pharms, Actavis Elizabeth, Ajanta Pharma Ltd, Amneal Pharms Ny, Chartwell Rx, Jubilant Generics, Novast Labs, Ph Health, Rubicon Research, Somerset Theraps Llc, Xiamen Lp Pharm Co, Alembic Pharms Ltd, Am Therap, Aurobindo Pharma Ltd, Chartwell Molecules, Duramed Pharms Barr, Impax Labs, Interpharm, Par Pharm, Prinston Inc, Rising, Sun Pharm Inds Inc, Teva, Tp Anda Holdings, Unichem, Warner Chilcott, Watson Labs, and Yung Shin Pharm, and is included in sixty-two NDAs. It is available from three suppliers. Additional details are available on the CLONIDINE profile page.

The generic ingredient in CLONIDINE is chlorthalidone; clonidine hydrochloride. There are twenty-one drug master file entries for this compound. Additional details are available on the chlorthalidone; clonidine hydrochloride profile page.

Summary for 076157

Tradename:	CLONIDINE
Applicant:	Ingenus Pharms Llc
Ingredient:	clonidine
Patents:	0

Medical Subject Heading (MeSH) Categories for 076157

Adrenergic alpha-2 Receptor Agonists
Analgesics
Antihypertensive Agents
Sympatholytics

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	SYSTEM;TRANSDERMAL			Strength	0.1MG/24HR
Approval Date:	Aug 18, 2009	TE:		RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	DISCN	Dosage:	SYSTEM;TRANSDERMAL			Strength	0.2MG/24HR
Approval Date:	Aug 18, 2009	TE:		RLD:	No

Profile for product number 003

Active Rx/OTC/Discontinued:	DISCN	Dosage:	SYSTEM;TRANSDERMAL			Strength	0.3MG/24HR
Approval Date:	Aug 18, 2009	TE:		RLD:	No

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