Hydroxyzine Pamoate

ANDA 88595, held by Duramed Pharms Barr. Hydroxyzine Pamoate.

As of Nov 15, 2026, ANDA 88595 (Hydroxyzine Pamoate), held by Duramed Pharms Barr, was first approved by FDA on Feb 29, 1984, with 3 approved supplements and 0 published complete response letters.

First approved: Feb 29, 1984
Supplements approved: 3
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 4 submissions below

Date	Submission	Status	Documents
Feb 29, 1984	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Hydroxyzine PamoateEQ 100MG HYDROCHLORIDE · capsule;oral	Hydroxyzine Pamoate	Discontinued

All 4 submissions, including labeling and manufacturing supplements


Dec 4, 1989	Supplement 15Labeling	Approved	None posted
Apr 14, 1989	Supplement 14Labeling	Approved	None posted
Sep 2, 1988	Supplement 12Labeling	Approved	None posted
Feb 29, 1984	Original application	Approved	None posted

Identifiers

Application: ANDA 88595
Drugs@FDA: Overview at FDA
Company: Duramed Pharmaceuticals (Barr)

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