Hydroxyzine Hydrochloride

ANDA 88349, held by Watson Labs. Hydroxyzine Hydrochloride.

As of Nov 15, 2026, ANDA 88349 (Hydroxyzine Hydrochloride), held by Watson Labs, was first approved by FDA on Sep 15, 1983, with 25 approved supplements and 0 published complete response letters.

First approved: Sep 15, 1983
Supplements approved: 25
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 26 submissions below

Date	Submission	Status	Documents
Sep 15, 1983	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Hydroxyzine Hydrochloride25MG · tablet;oral	Hydroxyzine Hydrochloride	Discontinued

All 26 submissions, including labeling and manufacturing supplements


Nov 8, 2016	Supplement 49Labeling · Standard review	Approved	None posted
Mar 30, 2016	Supplement 48Labeling · Standard review	Approved	None posted
Dec 22, 2014	Supplement 47Labeling · Standard review	Approved	None posted
Jan 30, 2002	Supplement 28Labeling	Approved	None posted
Nov 26, 2001	Supplement 29Manufacturing	Approved	None posted
Apr 25, 2001	Supplement 27Manufacturing	Approved	None posted
May 27, 1998	Supplement 25Manufacturing	Approved	None posted
May 27, 1998	Supplement 24Manufacturing	Approved	None posted
Mar 23, 1998	Supplement 23Manufacturing	Approved	None posted
Jan 29, 1993	Supplement 22Manufacturing	Approved	None posted
Jan 14, 1992	Supplement 18Manufacturing	Approved	None posted
Jan 14, 1992	Supplement 14Manufacturing	Approved	None posted
Aug 7, 1991	Supplement 20Manufacturing	Approved	None posted
Nov 19, 1990	Supplement 21Manufacturing	Approved	None posted
Jun 29, 1990	Supplement 19Manufacturing	Approved	None posted
Feb 14, 1989	Supplement 16Labeling	Approved	None posted
Dec 16, 1988	Supplement 12Manufacturing	Approved	None posted
Dec 16, 1988	Supplement 11Manufacturing	Approved	None posted
Nov 21, 1988	Supplement 15Labeling	Approved	None posted
Feb 12, 1986	Supplement 7Manufacturing	Approved	None posted
May 21, 1985	Supplement 5Manufacturing	Approved	None posted
May 21, 1985	Supplement 4Manufacturing	Approved	None posted
Feb 15, 1985	Supplement 3Manufacturing	Approved	None posted
Feb 15, 1985	Supplement 2Manufacturing	Approved	None posted
Sep 18, 1984	Supplement 1Manufacturing	Approved	None posted
Sep 15, 1983	Original application	Approved	None posted

Identifiers

Application: ANDA 88349
Drugs@FDA: Overview at FDA
Company: Watson Laboratories

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