Wytensin

NDA 18587, held by Wyeth Ayerst. Guanabenz Acetate.

As of Nov 13, 2026, NDA 18587 (Wytensin), held by Wyeth Ayerst, was first approved by FDA on Sep 7, 1982, with 20 approved supplements and 0 published complete response letters.

First approved: Sep 7, 1982
Review: Standard
Supplements approved: 20
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 21 submissions below

Date	Submission	Status	Documents
Sep 7, 1982	Original applicationNew molecular entity · Standard review	Approved	None posted

Products

3 strengths and forms

Product	Active ingredient	Marketing
WytensinEQ 4MG BASE · tablet;oral	Guanabenz Acetate	Discontinued
WytensinEQ 8MG BASE · tablet;oral	Guanabenz Acetate	Discontinued
WytensinEQ 16MG BASE · tablet;oral	Guanabenz Acetate	Discontinued

All 21 submissions, including labeling and manufacturing supplements

Date	Submission	Status	Documents
Nov 27, 2001	Supplement 23Labeling · Standard review	Approved	None posted
Jul 23, 1997	Supplement 22Labeling · Standard review	Approved	None posted
Jul 31, 1991	Supplement 21Labeling · Standard review	Approved	None posted
Apr 11, 1989	Supplement 17Manufacturing · Standard review	Approved	None posted
Jan 25, 1989	Supplement 20Labeling · Standard review	Approved	None posted
Sep 22, 1988	Supplement 19Labeling · Standard review	Approved	None posted
Apr 8, 1988	Supplement 18Manufacturing · Standard review	Approved	None posted
Apr 29, 1987	Supplement 11Labeling · Standard review	Approved	None posted
Oct 22, 1986	Supplement 15Labeling · Standard review	Approved	None posted
Apr 18, 1986	Supplement 12Manufacturing · Standard review	Approved	None posted
Mar 26, 1986	Supplement 14Manufacturing · Standard review	Approved	None posted
Feb 4, 1986	Supplement 13Manufacturing · Standard review	Approved	None posted
Dec 18, 1985	Supplement 10Manufacturing · Standard review	Approved	None posted
Oct 18, 1985	Supplement 9Labeling · Standard review	Approved	None posted
Sep 26, 1984	Supplement 6Manufacturing · Standard review	Approved	None posted
Jun 26, 1984	Supplement 5Labeling · Standard review	Approved	None posted
Feb 27, 1984	Supplement 4Labeling · Standard review	Approved	None posted
Dec 23, 1983	Supplement 3Manufacturing · Standard review	Approved	None posted
Jun 21, 1983	Supplement 2Manufacturing · Standard review	Approved	None posted
Jun 20, 1983	Supplement 1Manufacturing · Standard review	Approved	None posted
Sep 7, 1982	Original applicationNew molecular entity · Standard review	Approved	None posted

Identifiers

Application: NDA 18587
Drugs@FDA: Overview at FDA
Company: Wyeth-Ayerst

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