Hydroxyzine Pamoate

ANDA 87760, held by Ivax Sub Teva Pharms. Hydroxyzine Pamoate.

As of Nov 15, 2026, ANDA 87760 (Hydroxyzine Pamoate), held by Ivax Sub Teva Pharms, was first approved by FDA on Mar 5, 1982, with 19 approved supplements and 0 published complete response letters.

First approved: Mar 5, 1982
Supplements approved: 19
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 20 submissions below

Date	Submission	Status	Documents
Mar 5, 1982	Original application	Approved	None posted

Products

1 strengths and forms

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

All 20 submissions, including labeling and manufacturing supplements


Jul 29, 2002	Supplement 21Manufacturing	Approved	None posted
Sep 12, 2001	Supplement 20Manufacturing	Approved	None posted
Nov 13, 2000	Supplement 19Manufacturing	Approved	None posted
Jul 5, 2000	Supplement 18Labeling	Approved	None posted
Jul 5, 2000	Supplement 16Manufacturing	Approved	None posted
Jan 28, 2000	Supplement 17Manufacturing	Approved	None posted
Apr 30, 1999	Supplement 15Manufacturing	Approved	None posted
Apr 30, 1999	Supplement 14Manufacturing	Approved	None posted
Apr 30, 1999	Supplement 13Manufacturing	Approved	None posted
Dec 9, 1998	Supplement 12Manufacturing	Approved	None posted
May 30, 1997	Supplement 11Manufacturing	Approved	None posted
Oct 26, 1992	Supplement 7Manufacturing	Approved	None posted
Oct 16, 1992	Supplement 10Labeling	Approved	None posted
Sep 1, 1992	Supplement 6Manufacturing	Approved	None posted
Aug 25, 1989	Supplement 1Labeling	Approved	None posted
Feb 11, 1988	Supplement 5Manufacturing	Approved	None posted
Sep 15, 1987	Supplement 4Manufacturing	Approved	None posted
Sep 15, 1987	Supplement 3Manufacturing	Approved	None posted
Sep 15, 1987	Supplement 2Manufacturing	Approved	None posted
Mar 5, 1982	Original application	Approved	None posted

Identifiers

Application: ANDA 87760
Drugs@FDA: Overview at FDA
Company: IVAX Pharmaceuticals

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