Hytrin

NDA 19057, held by Abbott. Terazosin Hydrochloride.

As of Nov 13, 2026, NDA 19057 (Hytrin), held by Abbott, was first approved by FDA on Aug 7, 1987, with 20 approved supplements and 0 published complete response letters.

First approved: Aug 7, 1987
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
Aug 7, 1987	Original applicationNew molecular entity · Standard review	Approved	None posted

Products

4 strengths and forms

Product	Active ingredient	Marketing
HytrinEQ 1MG BASE · tablet;oral	Terazosin Hydrochloride	Discontinued
HytrinEQ 2MG BASE · tablet;oral	Terazosin Hydrochloride	Discontinued
HytrinEQ 5MG BASE · tablet;oral	Terazosin Hydrochloride	Discontinued
HytrinEQ 10MG BASE · tablet;oral	Terazosin Hydrochloride	Discontinued

All 21 submissions, including labeling and manufacturing supplements

Date	Submission	Status	Documents
Jul 10, 2009	Supplement 22Labeling · Standard review	Approved	Label Letter
Feb 6, 2006	Supplement 21Labeling · Standard review	Approved	Label Letter
Dec 24, 2002	Supplement 18Manufacturing · Standard review	Approved	None posted
Nov 15, 2002	Supplement 17Manufacturing · Standard review	Approved	None posted
Oct 4, 2002	Supplement 16Manufacturing · Standard review	Approved	None posted
Jan 23, 2002	Supplement 15Labeling · Standard review	Approved	Review Letter
Aug 6, 1998	Supplement 14Manufacturing · Standard review	Approved	None posted
Apr 16, 1998	Supplement 13Manufacturing · Standard review	Approved	None posted
Sep 18, 1996	Supplement 11Labeling · Standard review	Approved	None posted
Aug 8, 1996	Supplement 12Manufacturing · Standard review	Approved	None posted
Oct 6, 1995	Supplement 9Manufacturing · Standard review	Approved	None posted
Jul 11, 1995	Supplement 10Manufacturing · Standard review	Approved	None posted
Sep 14, 1994	Supplement 8Labeling · Standard review	Approved	None posted
Jun 17, 1994	Supplement 7Manufacturing · Standard review	Approved	None posted
Sep 29, 1993	Supplement 6Labeling · Standard review	Approved	None posted
Aug 20, 1993	Supplement 5Manufacturing · Standard review	Approved	None posted
Aug 9, 1991	Supplement 4Manufacturing · Standard review	Approved	None posted
Aug 10, 1990	Supplement 3Labeling · Standard review	Approved	None posted
Sep 20, 1988	Supplement 2Manufacturing · Standard review	Approved	None posted
Jul 1, 1988	Supplement 1Labeling · Standard review	Approved	None posted
Aug 7, 1987	Original applicationNew molecular entity · Standard review	Approved	None posted

Identifiers

Application: NDA 19057
Drugs@FDA: Overview at FDA
Company: Abbott

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