Hydroxyzine Hydrochloride

Relieves anxiety and tension associated with psychoneurosis. ANDA 40840, held by Northstar Hlthcare. Hydroxyzine Hydrochloride.

As of Nov 15, 2026, ANDA 40840 (Hydroxyzine Hydrochloride), held by Northstar Hlthcare, was first approved by FDA on Mar 31, 2008, with 6 approved supplements and 0 published complete response letters.

First approved: Mar 31, 2008
Supplements approved: 6
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 7 submissions below

Date	Submission	Status	Documents
Mar 31, 2008	Original application	Approved	None posted

Products

3 strengths and forms


Hydroxyzine Hydrochloride50MG · tablet;oral	Hydroxyzine Hydrochloride	Rx
Hydroxyzine Hydrochloride10MG · tablet;oral	Hydroxyzine Hydrochloride	Rx
Hydroxyzine Hydrochloride25MG · tablet;oral	Hydroxyzine Hydrochloride	Rx

All 7 submissions, including labeling and manufacturing supplements


Nov 8, 2016	Supplement 11Labeling · Standard review	Approved	None posted
Mar 30, 2016	Supplement 9Labeling · Standard review	Approved	None posted
Jun 3, 2014	Supplement 6Labeling · Standard review	Approved	None posted
Apr 30, 2014	Supplement 5Labeling · Standard review	Approved	None posted
Jan 17, 2013	Supplement 4Labeling · Standard review	Approved	None posted
Dec 8, 2011	Supplement 3Labeling	Approved	None posted
Mar 31, 2008	Original application	Approved	None posted

Identifiers

Application: ANDA 40840
Drugs@FDA: Overview at FDA
Company: Northstar Healthcare

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