Hydroxyzine Pamoate

ANDA 86840, held by Watson Labs. Hydroxyzine Pamoate.

As of Nov 15, 2026, ANDA 86840 (Hydroxyzine Pamoate), held by Watson Labs, was first approved by FDA on Jul 1, 1982, with 1 approved supplement and 0 published complete response letters.

First approved: Jul 1, 1982
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
Jul 1, 1982	Original application	Approved	None posted

Products

1 strengths and forms

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

All 2 submissions, including labeling and manufacturing supplements


Feb 12, 1991	Supplement 11Labeling	Approved	None posted
Jul 1, 1982	Original application	Approved	None posted

Identifiers

Application: ANDA 86840
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