Hydroxyzine Pamoate

ANDA 81128, held by Sandoz. Hydroxyzine Pamoate.

As of Nov 15, 2026, ANDA 81128 (Hydroxyzine Pamoate), held by Sandoz, was first approved by FDA on Jun 28, 1991, with 1 approved supplement and 0 published complete response letters.

First approved: Jun 28, 1991
Supplements approved: 1
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 2 submissions below

Date	Submission	Status	Documents
Jun 28, 1991	Original application	Approved	None posted

Products

1 strengths and forms

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

All 2 submissions, including labeling and manufacturing supplements


Jan 24, 1994	Supplement 1Manufacturing	Approved	None posted
Jun 28, 1991	Original application	Approved	None posted

Identifiers

Application: ANDA 81128
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