Hydroxyzine Hydrochloride

ANDA 88184, held by Fresenius Kabi USA. Hydroxyzine Hydrochloride.

As of Nov 15, 2026, ANDA 88184 (Hydroxyzine Hydrochloride), held by Fresenius Kabi USA, was first approved by FDA on Mar 31, 1983, with 5 approved supplements and 0 published complete response letters.

First approved: Mar 31, 1983
Supplements approved: 5
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 6 submissions below

Date	Submission	Status	Documents
Mar 31, 1983	Original application	Approved	Other

Products

1 strengths and forms

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

All 6 submissions, including labeling and manufacturing supplements


May 21, 2007	Supplement 6Manufacturing	Approved	None posted
May 29, 1991	Supplement 5Labeling	Approved	None posted
Oct 5, 1990	Supplement 3Manufacturing	Approved	None posted
Oct 5, 1990	Supplement 4Manufacturing	Approved	None posted
Jun 3, 1988	Supplement 2Manufacturing	Approved	None posted
Mar 31, 1983	Original application	Approved	Other

Identifiers

Application: ANDA 88184
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