Hydroxyzine Hydrochloride

Relieves anxiety and tension associated with psychoneurosis. ANDA 88619, held by Pliva. Hydroxyzine Hydrochloride.

As of Nov 15, 2026, ANDA 88619 (Hydroxyzine Hydrochloride), held by Pliva, was first approved by FDA on Jan 10, 1986, with 16 approved supplements and 0 published complete response letters.

First approved: Jan 10, 1986
Supplements approved: 16
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 a 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 17 submissions below

Date	Submission	Status	Documents
Jan 10, 1986	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Hydroxyzine Hydrochloride50MG · tablet;oral	Hydroxyzine Hydrochloride	RxReference drug

All 17 submissions, including labeling and manufacturing supplements


Nov 8, 2016	Supplement 48Labeling · Standard review	Approved	None posted
Mar 30, 2016	Supplement 46Labeling · Standard review	Approved	None posted
Mar 29, 2016	Supplement 45Labeling · Standard review	Approved	None posted
Jun 5, 2014	Supplement 44Labeling · Standard review	Approved	Label Letter
Aug 5, 2008	Supplement 31Labeling	Approved	Label
Feb 4, 2004	Supplement 19Labeling	Approved	None posted
Jan 30, 2002	Supplement 13Labeling	Approved	None posted
Jul 7, 2000	Supplement 12Manufacturing	Approved	None posted
Feb 6, 1998	Supplement 11Manufacturing	Approved	None posted
Feb 6, 1998	Supplement 10Manufacturing	Approved	None posted
May 24, 1994	Supplement 8Labeling	Approved	None posted
May 11, 1994	Supplement 9Manufacturing	Approved	None posted
Jan 14, 1991	Supplement 7Labeling	Approved	None posted
Aug 1, 1986	Supplement 3Manufacturing	Approved	None posted
Apr 11, 1986	Supplement 1Manufacturing	Approved	None posted
Feb 5, 1986	Supplement 2Manufacturing	Approved	None posted
Jan 10, 1986	Original application	Approved	None posted

Identifiers

Application: ANDA 88619
Drugs@FDA: Overview at FDA
Company: PLIVA

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