Hydroxyzine Hydrochloride

ANDA 86821, held by Hospira. Hydroxyzine Hydrochloride.

As of Nov 15, 2026, ANDA 86821 (Hydroxyzine Hydrochloride), held by Hospira, was first approved by FDA on Sep 5, 1979, with 5 approved supplements and 0 published complete response letters.

First approved: Sep 5, 1979
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
Sep 5, 1979	Original application	Approved	None posted

Products

1 strengths and forms

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

All 6 submissions, including labeling and manufacturing supplements


May 5, 1998	Supplement 13Manufacturing	Approved	None posted
Jan 16, 1997	Supplement 11Manufacturing	Approved	None posted
Oct 3, 1996	Supplement 12Manufacturing	Approved	None posted
May 24, 1982	Supplement 8Manufacturing	Approved	None posted
May 24, 1982	Supplement 7Manufacturing	Approved	None posted
Sep 5, 1979	Original application	Approved	None posted

Identifiers

Application: ANDA 86821
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