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Last Updated: April 21, 2025

Details for New Drug Application (NDA): 210052

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NDA 210052 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, Dr Reddys Labs Sa, Endo Operations, Jubilant Generics, Novast Labs, 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, Trupharma, Unichem, Warner Chilcott, Watson Labs, and Yung Shin Pharm, and is included in fifty-seven NDAs. It is available from forty-two 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 210052

Tradename:	CLONIDINE HYDROCHLORIDE
Applicant:	Amneal Pharms Ny
Ingredient:	clonidine hydrochloride
Patents:	0

Pharmacology for NDA: 210052

Mechanism of Action	Adrenergic alpha2-Agonists

Suppliers and Packaging for NDA: 210052

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
CLONIDINE HYDROCHLORIDE	clonidine hydrochloride	TABLET, EXTENDED RELEASE;ORAL	210052	ANDA	Amneal Pharmaceuticals NY LLC	69238-1426	69238-1426-6	60 TABLET, EXTENDED RELEASE in 1 BOTTLE (69238-1426-6)

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET, EXTENDED RELEASE;ORAL			Strength	0.1MG
Approval Date:	Nov 20, 2017	TE:		RLD:	No

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