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Last Updated: November 2, 2024

Details for New Drug Application (NDA): 200300

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NDA 200300 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, Unichem, Url Labs, 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 200300

Tradename:	CLONIDINE HYDROCHLORIDE
Applicant:	Hikma Farmaceutica
Ingredient:	clonidine hydrochloride
Patents:	0

Pharmacology for NDA: 200300

Mechanism of Action	Adrenergic alpha2-Agonists

Suppliers and Packaging for NDA: 200300

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
CLONIDINE HYDROCHLORIDE	clonidine hydrochloride	INJECTABLE;INJECTION	200300	ANDA	Hikma Pharmaceuticals USA Inc.	0143-9723	0143-9723-01	10 mL in 1 VIAL, SINGLE-USE (0143-9723-01)
CLONIDINE HYDROCHLORIDE	clonidine hydrochloride	INJECTABLE;INJECTION	200300	ANDA	Hikma Pharmaceuticals USA Inc.	0143-9724	0143-9724-01	10 mL in 1 VIAL, SINGLE-USE (0143-9724-01)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;INJECTION			Strength	1MG/10ML (0.1MG/ML)
Approval Date:	Jan 26, 2011	TE:	AP	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;INJECTION			Strength	5MG/10ML (0.5MG/ML)
Approval Date:	Jan 26, 2011	TE:	AP	RLD:	No

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