Hydroxyzine Hydrochloride

ANDA 88350, held by Watson Labs. Hydroxyzine Hydrochloride.

As of Nov 15, 2026, ANDA 88350 (Hydroxyzine Hydrochloride), held by Watson Labs, was first approved by FDA on Sep 15, 1983, with 20 approved supplements and 0 published complete response letters.

First approved: Sep 15, 1983
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 15, 1983	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Hydroxyzine Hydrochloride50MG · tablet;oral	Hydroxyzine Hydrochloride	Discontinued

All 21 submissions, including labeling and manufacturing supplements


Nov 8, 2016	Supplement 47Labeling · Standard review	Approved	None posted
Mar 30, 2016	Supplement 46Labeling · Standard review	Approved	None posted
Dec 31, 2014	Supplement 45Labeling · Standard review	Approved	None posted
Jan 30, 2002	Supplement 23Labeling	Approved	None posted
Nov 26, 2001	Supplement 24Manufacturing	Approved	None posted
Mar 23, 1998	Supplement 18Manufacturing	Approved	None posted
Jan 29, 1993	Supplement 17Manufacturing	Approved	None posted
Jan 30, 1992	Supplement 13Manufacturing	Approved	None posted
Jan 30, 1992	Supplement 12Manufacturing	Approved	None posted
Jan 30, 1992	Supplement 9Manufacturing	Approved	None posted
Jan 30, 1992	Supplement 8Manufacturing	Approved	None posted
Aug 7, 1991	Supplement 15Manufacturing	Approved	None posted
Nov 19, 1990	Supplement 16Manufacturing	Approved	None posted
Jun 29, 1990	Supplement 14Manufacturing	Approved	None posted
Feb 14, 1989	Supplement 11Labeling	Approved	None posted
Nov 21, 1988	Supplement 10Labeling	Approved	None posted
Feb 12, 1986	Supplement 4Manufacturing	Approved	None posted
Feb 15, 1985	Supplement 3Manufacturing	Approved	None posted
Feb 15, 1985	Supplement 2Manufacturing	Approved	None posted
Sep 20, 1984	Supplement 1Manufacturing	Approved	None posted
Sep 15, 1983	Original application	Approved	None posted

Identifiers

Application: ANDA 88350
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