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Last Updated: December 15, 2025

Details for New Drug Application (NDA): 076166

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NDA 076166 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 076166

Tradename:	CLONIDINE
Applicant:	Mylan Technologies
Ingredient:	clonidine
Patents:	0

Pharmacology for NDA: 076166

Mechanism of Action	Adrenergic alpha2-Agonists

Medical Subject Heading (MeSH) Categories for 076166

Adrenergic alpha-2 Receptor Agonists
Analgesics
Antihypertensive Agents
Sympatholytics

Suppliers and Packaging for NDA: 076166

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
CLONIDINE	clonidine	SYSTEM;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	SYSTEM;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

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	SYSTEM;TRANSDERMAL			Strength	0.1MG/24HR
Approval Date:	Jul 16, 2010	TE:	AB	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	SYSTEM;TRANSDERMAL			Strength	0.2MG/24HR
Approval Date:	Jul 16, 2010	TE:	AB	RLD:	No

Profile for product number 003

Active Rx/OTC/Discontinued:	RX	Dosage:	SYSTEM;TRANSDERMAL			Strength	0.3MG/24HR
Approval Date:	Jul 16, 2010	TE:	AB	RLD:	No

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