Hydroxyzine Hydrochloride

ANDA 81150, held by Watson Labs. Hydroxyzine Hydrochloride.

As of Nov 15, 2026, ANDA 81150 (Hydroxyzine Hydrochloride), held by Watson Labs, was first approved by FDA on Mar 18, 1994, with 10 approved supplements and 0 published complete response letters.

First approved: Mar 18, 1994
Supplements approved: 10
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 11 submissions below

Date	Submission	Status	Documents
Mar 18, 1994	Original application	Approved	None posted

Products

1 strengths and forms

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

All 11 submissions, including labeling and manufacturing supplements


Nov 8, 2016	Supplement 13Labeling · Standard review	Approved	None posted
Mar 30, 2016	Supplement 12Labeling · Standard review	Approved	None posted
Jun 4, 2014	Supplement 11Labeling · Standard review	Approved	None posted
Apr 12, 2001	Supplement 10Manufacturing	Approved	None posted
Mar 21, 2000	Supplement 8Manufacturing	Approved	None posted
Sep 25, 1998	Supplement 7Manufacturing	Approved	None posted
Jul 8, 1997	Supplement 5Manufacturing	Approved	None posted
Mar 26, 1997	Supplement 4Manufacturing	Approved	None posted
Dec 31, 1996	Supplement 1Manufacturing	Approved	None posted
Dec 31, 1996	Supplement 2Manufacturing	Approved	None posted
Mar 18, 1994	Original application	Approved	None posted

Identifiers

Application: ANDA 81150
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