Application 201382

Type: ANDA
Sponsor: TEVA PHARMS USA

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	GUANFACINE HYDROCHLORIDE	GUANFACINE HYDROCHLORIDE	TABLET, EXTENDED RELEASE;ORAL	EQ 1MG BASE	No	No
002	GUANFACINE HYDROCHLORIDE	GUANFACINE HYDROCHLORIDE	TABLET, EXTENDED RELEASE;ORAL	EQ 2MG BASE	No	No
003	GUANFACINE HYDROCHLORIDE	GUANFACINE HYDROCHLORIDE	TABLET, EXTENDED RELEASE;ORAL	EQ 3MG BASE	No	No
004	GUANFACINE HYDROCHLORIDE	GUANFACINE HYDROCHLORIDE	TABLET, EXTENDED RELEASE;ORAL	EQ 4MG BASE	No	No

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0093-5960	Guanfacine	Guanfacine	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-5960	Guanfacine	Guanfacine	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-5960	Guanfacine	Guanfacine	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-5960	Guanfacine	Guanfacine	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-5960	Guanfacine	Guanfacine	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-5960	Guanfacine	Guanfacine	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-5960	Guanfacine	Guanfacine	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-5961	Guanfacine	Guanfacine	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-5961	Guanfacine	Guanfacine	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-5961	Guanfacine	Guanfacine	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-5961	Guanfacine	Guanfacine	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-5961	Guanfacine	Guanfacine	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-5961	Guanfacine	Guanfacine	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-5961	Guanfacine	Guanfacine	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-5963	Guanfacine	Guanfacine	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-5963	Guanfacine	Guanfacine	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-5963	Guanfacine	Guanfacine	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-5963	Guanfacine	Guanfacine	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-5963	Guanfacine	Guanfacine	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-5963	Guanfacine	Guanfacine	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-5964	Guanfacine	Guanfacine	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-5964	Guanfacine	Guanfacine	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-5964	Guanfacine	Guanfacine	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-5964	Guanfacine	Guanfacine	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-5964	Guanfacine	Guanfacine	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-5964	Guanfacine	Guanfacine	Teva Pharmaceuticals USA, Inc.	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
32111	ORIG	2015-06-04

Application 201382

Related Records#

Application Products#

NDC Listings For This Application#

Documents#