Hydroxyzine Hydrochloride

ANDA 88185, held by Fresenius Kabi USA. Hydroxyzine Hydrochloride.

As of Nov 15, 2026, ANDA 88185 (Hydroxyzine Hydrochloride), held by Fresenius Kabi USA, was first approved by FDA on Mar 31, 1983, with 10 approved supplements and 0 published complete response letters.

First approved: Mar 31, 1983
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 31, 1983	Original application	Approved	Other

Products

1 strengths and forms

Product	Active ingredient	Marketing
Hydroxyzine Hydrochloride50MG/ML · injectable;injection	Hydroxyzine Hydrochloride	Discontinued

All 11 submissions, including labeling and manufacturing supplements


May 21, 2007	Supplement 15Manufacturing	Approved	None posted
Oct 22, 1991	Supplement 13Labeling	Approved	None posted
May 29, 1991	Supplement 12Labeling	Approved	None posted
Mar 18, 1991	Supplement 11Labeling	Approved	None posted
Oct 5, 1990	Supplement 8Manufacturing	Approved	None posted
Oct 5, 1990	Supplement 9Manufacturing	Approved	None posted
Oct 5, 1990	Supplement 10Manufacturing	Approved	None posted
May 27, 1988	Supplement 7Manufacturing	Approved	None posted
Jul 6, 1987	Supplement 5Manufacturing	Approved	None posted
Jul 6, 1987	Supplement 6Manufacturing	Approved	None posted
Mar 31, 1983	Original application	Approved	Other

Identifiers

Application: ANDA 88185
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