Hydroxyzine Pamoate

ANDA 81165, held by Watson Labs. Hydroxyzine Pamoate.

As of Nov 15, 2026, ANDA 81165 (Hydroxyzine Pamoate), held by Watson Labs, was first approved by FDA on Jul 31, 1991, with 8 approved supplements and 0 published complete response letters.

First approved: Jul 31, 1991
Supplements approved: 8
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 9 submissions below

Date	Submission	Status	Documents
Jul 31, 1991	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Hydroxyzine PamoateEQ 25MG HYDROCHLORIDE · capsule;oral	Hydroxyzine Pamoate	Discontinued

All 9 submissions, including labeling and manufacturing supplements


Feb 22, 2002	Supplement 9Labeling	Approved	None posted
Apr 25, 2001	Supplement 8Manufacturing	Approved	None posted
Dec 9, 1998	Supplement 6Manufacturing	Approved	None posted
Mar 12, 1998	Supplement 4Manufacturing	Approved	None posted
Dec 15, 1997	Supplement 5Manufacturing	Approved	None posted
Mar 18, 1996	Supplement 3Labeling	Approved	None posted
Feb 10, 1995	Supplement 2Labeling	Approved	None posted
Jun 7, 1994	Supplement 1Labeling	Approved	None posted
Jul 31, 1991	Original application	Approved	None posted

Identifiers

Application: ANDA 81165
Drugs@FDA: Overview at FDA
Company: Watson Laboratories

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