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Last Updated: December 17, 2025

Details for New Drug Application (NDA): 201382

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NDA 201382 describes GUANFACINE HYDROCHLORIDE, which is a drug marketed by Actavis Elizabeth, Alembic, Apotex, Fosun Wanbang, Impax Labs Inc, Pharmobedient, Rubicon Research, Sandoz, Sun Pharm, Teva Pharms Usa, Twi Pharms, Unichem, Yichang Humanwell, Aiping Pharm Inc, Ajanta Pharma Ltd, Amneal Pharm, Aurobindo Pharma Usa, Epic Pharma Llc, I 3 Pharms, Watson Labs, and Xiromed, and is included in twenty-four NDAs. It is available from thirty-seven suppliers. Additional details are available on the GUANFACINE HYDROCHLORIDE profile page.

The generic ingredient in GUANFACINE HYDROCHLORIDE is guanfacine hydrochloride. There are seven drug master file entries for this compound. Thirty-eight suppliers are listed for this compound. Additional details are available on the guanfacine hydrochloride profile page.

Summary for 201382

Tradename:	GUANFACINE HYDROCHLORIDE
Applicant:	Teva Pharms Usa
Ingredient:	guanfacine hydrochloride
Patents:	0

Medical Subject Heading (MeSH) Categories for 201382

Adrenergic alpha-2 Receptor Agonists
Antihypertensive Agents

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET, EXTENDED RELEASE;ORAL			Strength	EQ 1MG BASE
Approval Date:	Jun 2, 2015	TE:	AB	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET, EXTENDED RELEASE;ORAL			Strength	EQ 2MG BASE
Approval Date:	Jun 2, 2015	TE:	AB	RLD:	No

Profile for product number 003

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET, EXTENDED RELEASE;ORAL			Strength	EQ 3MG BASE
Approval Date:	Jun 2, 2015	TE:	AB	RLD:	No

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