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Last Updated: December 18, 2025

Details for New Drug Application (NDA): 203320

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NDA 203320 describes CLONIDINE HYDROCHLORIDE, which is a drug marketed by 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 fifty-seven NDAs. It is available from thirty-nine suppliers. Additional details are available on the CLONIDINE HYDROCHLORIDE profile page.

The generic ingredient in CLONIDINE HYDROCHLORIDE 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 203320

Tradename:	CLONIDINE HYDROCHLORIDE
Applicant:	Actavis Elizabeth
Ingredient:	clonidine hydrochloride
Patents:	0

Pharmacology for NDA: 203320

Mechanism of Action	Adrenergic alpha2-Agonists

Suppliers and Packaging for NDA: 203320

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
CLONIDINE HYDROCHLORIDE	clonidine hydrochloride	TABLET, EXTENDED RELEASE;ORAL	203320	ANDA	Actavis Pharma, Inc.	0228-4241	0228-4241-06	60 TABLET, EXTENDED RELEASE in 1 BOTTLE (0228-4241-06)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET, EXTENDED RELEASE;ORAL			Strength	0.1MG
Approval Date:	May 15, 2015	TE:	AB1	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET, EXTENDED RELEASE;ORAL			Strength	0.2MG
Approval Date:	May 15, 2015	TE:		RLD:	No

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