Hydroxyzine Pamoate

Relieves anxiety and tension associated with psychoneurosis. ANDA 86183, held by Sandoz. Hydroxyzine Pamoate.

As of Nov 15, 2026, ANDA 86183 (Hydroxyzine Pamoate), held by Sandoz, was first approved by FDA on Dec 14, 1981, with 22 approved supplements and 0 published complete response letters.

First approved: Dec 14, 1981
Supplements approved: 22
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

INDICATIONS 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 (Demerol ) 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 23 submissions below

Date	Submission	Status	Documents
Dec 14, 1981	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Hydroxyzine PamoateEQ 50MG HYDROCHLORIDE · capsule;oral	Hydroxyzine Pamoate	Rx

All 23 submissions, including labeling and manufacturing supplements


Feb 16, 2021	Supplement 40Labeling · Standard review	Approved	None posted
Feb 16, 2021	Supplement 39Labeling · Standard review	Approved	None posted
Jan 24, 2015	Supplement 37Labeling · Standard review	Approved	None posted
Jul 22, 2013	Supplement 32Labeling · Standard review	Approved	None posted
Dec 20, 2002	Supplement 24Labeling	Approved	None posted
Feb 2, 2000	Supplement 23Manufacturing	Approved	None posted
Jun 24, 1996	Supplement 22Labeling	Approved	None posted
May 22, 1996	Supplement 20Labeling	Approved	None posted
Apr 12, 1996	Supplement 21Manufacturing	Approved	None posted
Mar 3, 1995	Supplement 18Manufacturing	Approved	None posted
Mar 3, 1995	Supplement 17Manufacturing	Approved	None posted
Dec 12, 1994	Supplement 15Manufacturing	Approved	None posted
Dec 12, 1994	Supplement 12Manufacturing	Approved	None posted
Dec 9, 1994	Supplement 19Manufacturing	Approved	None posted
Dec 9, 1994	Supplement 14Manufacturing	Approved	None posted
Jul 28, 1992	Supplement 16Labeling	Approved	None posted
May 9, 1989	Supplement 11Labeling	Approved	None posted
Jan 17, 1986	Supplement 9Manufacturing	Approved	None posted
Jan 17, 1986	Supplement 8Manufacturing	Approved	None posted
Dec 9, 1982	Supplement 6Manufacturing	Approved	None posted
Dec 9, 1982	Supplement 5Manufacturing	Approved	None posted
Dec 9, 1982	Supplement 1Manufacturing	Approved	None posted
Dec 14, 1981	Original application	Approved	None posted

Identifiers

Application: ANDA 86183
Drugs@FDA: Overview at FDA
Company: Sandoz

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