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Last Updated: December 11, 2025

Details for New Drug Application (NDA): 202297

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NDA 202297 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 202297

Tradename:	CLONIDINE HYDROCHLORIDE
Applicant:	Yung Shin Pharm
Ingredient:	clonidine hydrochloride
Patents:	0

Pharmacology for NDA: 202297

Mechanism of Action	Adrenergic alpha2-Agonists

Suppliers and Packaging for NDA: 202297

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
CLONIDINE HYDROCHLORIDE	clonidine hydrochloride	TABLET;ORAL	202297	ANDA	Method Pharmaceuticals, LLC	58657-647	58657-647-01	100 TABLET in 1 BOTTLE (58657-647-01)
CLONIDINE HYDROCHLORIDE	clonidine hydrochloride	TABLET;ORAL	202297	ANDA	Method Pharmaceuticals, LLC	58657-647	58657-647-10	1000 TABLET in 1 BOTTLE (58657-647-10)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	0.1MG
Approval Date:	Jun 13, 2013	TE:	AB	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	0.2MG
Approval Date:	Jun 13, 2013	TE:	AB	RLD:	No

Profile for product number 003

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	0.3MG
Approval Date:	Jun 13, 2013	TE:	AB	RLD:	No

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