Tenex

NDA 19032, held by Promius Pharma. Guanfacine Hydrochloride.

As of Nov 13, 2026, NDA 19032 (Tenex), held by Promius Pharma, was first approved by FDA on Oct 27, 1986, with 17 approved supplements and 0 published complete response letters.

First approved: Oct 27, 1986
Review: Standard
Supplements approved: 17
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 18 submissions below


May 11, 1993	Supplement 10Efficacy (new indication or use)	Approved	None posted
Oct 27, 1986	Original applicationNew molecular entity · Standard review	Approved	Review

Products

3 strengths and forms


TenexEQ 1MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · tablet;oral	Guanfacine Hydrochloride	DiscontinuedReference drug
TenexEQ 2MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · tablet;oral	Guanfacine Hydrochloride	DiscontinuedReference drug
TenexEQ 3MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · tablet;oral	Guanfacine Hydrochloride	Discontinued

All 18 submissions, including labeling and manufacturing supplements


Jul 3, 2013	Supplement 21Labeling · Standard review	Approved	Letter Label
Mar 12, 2002	Supplement 17Labeling · Standard review	Approved	Review Letter
Mar 12, 2002	Supplement 16Labeling · Standard review	Approved	Review Letter
Jan 13, 1998	Supplement 15Manufacturing · Standard review	Approved	None posted
May 11, 1993	Supplement 10Efficacy (new indication or use)	Approved	None posted
Sep 17, 1991	Supplement 14Manufacturing · Standard review	Approved	None posted
Mar 1, 1991	Supplement 13Manufacturing · Standard review	Approved	None posted
Feb 1, 1990	Supplement 11Labeling	Approved	None posted
Nov 29, 1989	Supplement 12Manufacturing · Standard review	Approved	None posted
Nov 7, 1988	Supplement 9Labeling	Approved	None posted
Nov 7, 1988	Supplement 7Manufacturing · Standard review	Approved	None posted
Jun 9, 1988	Supplement 8Manufacturing · Standard review	Approved	None posted
Dec 28, 1987	Supplement 6Manufacturing · Standard review	Approved	None posted
Nov 20, 1987	Supplement 5Manufacturing · Standard review	Approved	None posted
Apr 29, 1987	Supplement 4Manufacturing · Standard review	Approved	None posted
Feb 17, 1987	Supplement 2Manufacturing · Standard review	Approved	None posted
Feb 17, 1987	Supplement 1Manufacturing · Standard review	Approved	None posted
Oct 27, 1986	Original applicationNew molecular entity · Standard review	Approved	Review

Identifiers

Application: NDA 19032
Drugs@FDA: Overview at FDA
Company: Promius Pharma

Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters