Hydroxyzine Hydrochloride

ANDA 87329, held by Fresenius Kabi USA. Hydroxyzine Hydrochloride.

As of Nov 15, 2026, ANDA 87329 (Hydroxyzine Hydrochloride), held by Fresenius Kabi USA, was first approved by FDA on Aug 11, 1981, with 14 approved supplements and 0 published complete response letters.

First approved: Aug 11, 1981
Supplements approved: 14
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 15 submissions below

Date	Submission	Status	Documents
Aug 11, 1981	Original application	Approved	None posted

Products

2 strengths and forms


Hydroxyzine Hydrochloride25MG/ML · injectable;injection	Hydroxyzine Hydrochloride	Discontinued
Hydroxyzine Hydrochloride50MG/ML · injectable;injection	Hydroxyzine Hydrochloride	Discontinued

All 15 submissions, including labeling and manufacturing supplements


Nov 8, 2016	Supplement 22Labeling · Standard review	Approved	None posted
Mar 30, 2016	Supplement 21Labeling · Standard review	Approved	None posted
Sep 25, 2014	Supplement 20Labeling · Standard review	Approved	Label Letter
Jun 4, 2014	Supplement 19Labeling · Standard review	Approved	Label Letter
Dec 5, 2002	Supplement 14Manufacturing	Approved	None posted
Jul 5, 1996	Supplement 10Manufacturing	Approved	None posted
Jun 24, 1996	Supplement 12Manufacturing	Approved	None posted
Sep 23, 1994	Supplement 8Manufacturing	Approved	None posted
Jun 23, 1993	Supplement 9Labeling	Approved	None posted
Mar 20, 1990	Supplement 7Labeling	Approved	None posted
Dec 13, 1984	Supplement 6Manufacturing	Approved	None posted
Oct 2, 1984	Supplement 5Manufacturing	Approved	None posted
Oct 2, 1984	Supplement 4Manufacturing	Approved	None posted
Oct 13, 1982	Supplement 1Manufacturing	Approved	None posted
Aug 11, 1981	Original application	Approved	None posted

Identifiers

Application: ANDA 87329
Drugs@FDA: Overview at FDA
Company: Fresenius Kabi USA

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