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Last Updated: December 17, 2025

Details for New Drug Application (NDA): 091368

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NDA 091368 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 091368

Tradename:	CLONIDINE HYDROCHLORIDE
Applicant:	Alembic Pharms Ltd
Ingredient:	clonidine hydrochloride
Patents:	0

Pharmacology for NDA: 091368

Mechanism of Action	Adrenergic alpha2-Agonists

Suppliers and Packaging for NDA: 091368

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
CLONIDINE HYDROCHLORIDE	clonidine hydrochloride	TABLET;ORAL	091368	ANDA	Alembic Pharmaceuticals Limited	46708-306	46708-306-10	100 TABLET in 1 CARTON (46708-306-10)
CLONIDINE HYDROCHLORIDE	clonidine hydrochloride	TABLET;ORAL	091368	ANDA	Alembic Pharmaceuticals Limited	46708-306	46708-306-30	30 TABLET in 1 BOTTLE (46708-306-30)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	0.1MG
Approval Date:	Dec 6, 2011	TE:	AB	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	0.2MG
Approval Date:	Dec 6, 2011	TE:	AB	RLD:	No

Profile for product number 003

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	0.3MG
Approval Date:	Dec 6, 2011	TE:	AB	RLD:	No

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