Hydroxyzine Hydrochloride

Relieves anxiety and tension associated with psychoneurosis. ANDA 87294, held by Chartwell Rx. Hydroxyzine Hydrochloride.

As of Nov 15, 2026, ANDA 87294 (Hydroxyzine Hydrochloride), held by Chartwell Rx, was first approved by FDA on Apr 12, 1982, with 20 approved supplements and 0 published complete response letters.

First approved: Apr 12, 1982
Supplements approved: 20
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

INDICATIONS AND USAGE For symptomatic relief of anxiety and tension associated with psychoneurosis and as an adjunct in organic disease states in which anxiety is manifested. Useful in the management of pruritus due to allergic conditions such as chronic urticaria and atopic and contact dermatoses, and in histamine-mediated pruritus. As a sedative when used as premedication and following general anesthesia, hydroxyzine may potentiate meperidine and barbiturates, so their use in pre-anesthetic adjunctive therapy should be modified on an individual basis. Atropine and other belladonna alkaloids are not affected by the drug.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 21 submissions below

Date	Submission	Status	Documents
Apr 12, 1982	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Hydroxyzine Hydrochloride10MG/5ML · syrup;oral	Hydroxyzine Hydrochloride	RxReference drug

All 21 submissions, including labeling and manufacturing supplements


Nov 8, 2016	Supplement 28Labeling · Standard review	Approved	Letter Label
Mar 30, 2016	Supplement 27Labeling · Standard review	Approved	None posted
Jun 3, 2014	Supplement 26Labeling · Standard review	Approved	Label Letter
Apr 4, 2005	Supplement 23Labeling	Approved	None posted
Jun 13, 2003	Supplement 21Labeling	Approved	None posted
Aug 22, 2002	Supplement 20Labeling	Approved	None posted
Dec 27, 1993	Supplement 19Labeling	Approved	None posted
Sep 8, 1993	Supplement 14Manufacturing	Approved	None posted
Feb 11, 1991	Supplement 18Labeling	Approved	None posted
Feb 11, 1991	Supplement 17Labeling	Approved	None posted
Feb 11, 1991	Supplement 16Labeling	Approved	None posted
Jun 19, 1990	Supplement 15Labeling	Approved	None posted
Jun 20, 1989	Supplement 13Labeling	Approved	None posted
Feb 7, 1989	Supplement 12Manufacturing	Approved	None posted
Dec 9, 1988	Supplement 11Manufacturing	Approved	None posted
Apr 7, 1987	Supplement 10Manufacturing	Approved	None posted
Oct 22, 1985	Supplement 7Manufacturing	Approved	None posted
Dec 13, 1984	Supplement 6Manufacturing	Approved	None posted
Dec 13, 1984	Supplement 5Manufacturing	Approved	None posted
Mar 16, 1984	Supplement 3Manufacturing	Approved	None posted
Apr 12, 1982	Original application	Approved	None posted

Identifiers

Application: ANDA 87294
Drugs@FDA: Overview at FDA
Company: Chartwell RX

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