Hydroxyzine Hydrochloride

ANDA 87546, held by Hospira. Hydroxyzine Hydrochloride.

As of Nov 15, 2026, ANDA 87546 (Hydroxyzine Hydrochloride), held by Hospira, was first approved by FDA on Jun 15, 1981, with 7 approved supplements and 0 published complete response letters.

First approved: Jun 15, 1981
Supplements approved: 7
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 8 submissions below

Date	Submission	Status	Documents
Jun 15, 1981	Original application	Approved	None posted

Products

1 strengths and forms

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

All 8 submissions, including labeling and manufacturing supplements


Feb 14, 2001	Supplement 10Manufacturing	Approved	None posted
Dec 22, 1995	Supplement 9Manufacturing	Approved	None posted
Jul 19, 1991	Supplement 7Labeling	Approved	None posted
Dec 26, 1989	Supplement 5Manufacturing	Approved	None posted
Dec 26, 1989	Supplement 4Manufacturing	Approved	None posted
Sep 12, 1989	Supplement 6Labeling	Approved	None posted
Jul 31, 1989	Supplement 3Labeling	Approved	None posted
Jun 15, 1981	Original application	Approved	None posted

Identifiers

Application: ANDA 87546
Drugs@FDA: Overview at FDA
Company: Hospira

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