Hydroxyzine Hydrochloride

ANDA 85778, held by Watson Labs. Hydroxyzine Hydrochloride.

As of Nov 15, 2026, ANDA 85778 (Hydroxyzine Hydrochloride), held by Watson Labs, was first approved by FDA on Oct 5, 1979, with 21 approved supplements and 0 published complete response letters.

First approved: Oct 5, 1979
Supplements approved: 21
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 22 submissions below

Date	Submission	Status	Documents
Oct 5, 1979	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Hydroxyzine Hydrochloride25MG/ML · injectable;injection	Hydroxyzine Hydrochloride	Discontinued

All 22 submissions, including labeling and manufacturing supplements


Nov 8, 2016	Supplement 54Labeling · Standard review	Approved	None posted
Mar 30, 2016	Supplement 53Labeling · Standard review	Approved	None posted
Jun 3, 2014	Supplement 52Labeling · Standard review	Approved	None posted
Feb 19, 1999	Supplement 50Manufacturing	Approved	None posted
Feb 2, 1999	Supplement 49Manufacturing	Approved	None posted
Dec 4, 1996	Supplement 48Manufacturing	Approved	None posted
May 23, 1991	Supplement 47Labeling	Approved	None posted
Jan 25, 1991	Supplement 46Labeling	Approved	None posted
Dec 4, 1989	Supplement 44Labeling	Approved	None posted
Dec 4, 1989	Supplement 45Labeling	Approved	None posted
Nov 30, 1988	Supplement 37Bioequivalence	Approved	None posted
Nov 15, 1988	Supplement 39Manufacturing	Approved	None posted
Nov 15, 1988	Supplement 40Manufacturing	Approved	None posted
Oct 2, 1986	Supplement 36Manufacturing	Approved	None posted
Dec 30, 1983	Supplement 35Manufacturing	Approved	None posted
Jun 15, 1982	Supplement 1Manufacturing	Approved	None posted
Jun 15, 1982	Supplement 13Manufacturing	Approved	None posted
Jun 15, 1982	Supplement 17Manufacturing	Approved	None posted
Jun 15, 1982	Supplement 30Manufacturing	Approved	None posted
Jun 15, 1982	Supplement 31Manufacturing	Approved	None posted
Jun 15, 1982	Supplement 33Manufacturing	Approved	None posted
Oct 5, 1979	Original application	Approved	None posted

Identifiers

Application: ANDA 85778
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