Hytrin

NDA 20347, held by Abbott. Terazosin Hydrochloride.

As of Nov 13, 2026, NDA 20347 (Hytrin), held by Abbott, was first approved by FDA on Dec 14, 1994, with 8 approved supplements and 0 published complete response letters.

First approved: Dec 14, 1994
Review: Standard
Supplements approved: 8
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 9 submissions below

Date	Submission	Status	Documents
Dec 14, 1994	Original applicationNew dosage form · Standard review	Approved	None posted

Products

4 strengths and forms

Product	Active ingredient	Marketing
HytrinEQ 1MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · capsule;oral	Terazosin Hydrochloride	DiscontinuedReference drug
HytrinEQ 2MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · capsule;oral	Terazosin Hydrochloride	DiscontinuedReference drug
HytrinEQ 5MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · capsule;oral	Terazosin Hydrochloride	DiscontinuedReference drug
HytrinEQ 10MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · capsule;oral	Terazosin Hydrochloride	DiscontinuedReference drug

All 9 submissions, including labeling and manufacturing supplements

Date	Submission	Status	Documents
Feb 6, 2006	Supplement 9Labeling · Standard review	Approved	Label Letter
Oct 4, 2002	Supplement 7Manufacturing · Standard review	Approved	None posted
Jan 23, 2002	Supplement 6Labeling · Standard review	Approved	Review Letter
Aug 6, 1998	Supplement 5Manufacturing · Standard review	Approved	None posted
Apr 16, 1998	Supplement 4Manufacturing · Standard review	Approved	None posted
Sep 18, 1996	Supplement 2Labeling · Standard review	Approved	None posted
Aug 8, 1996	Supplement 3Manufacturing · Standard review	Approved	None posted
Mar 14, 1995	Supplement 1Manufacturing · Standard review	Approved	None posted
Dec 14, 1994	Original applicationNew dosage form · Standard review	Approved	None posted

Identifiers

Application: NDA 20347
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