PROMIUS PHARMA Application 019032

Application Products#

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

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
67857-705	TENEX	guanfacine hydrochloride	Promius Pharma, LLC	NDA	Current
67857-706	TENEX	guanfacine hydrochloride	Promius Pharma, LLC	NDA	Current