Hydroxyzine Pamoate

ANDA 87767, held by Watson Labs. Hydroxyzine Pamoate.

As of Nov 15, 2026, ANDA 87767 (Hydroxyzine Pamoate), held by Watson Labs, was first approved by FDA on Aug 16, 1982, with 4 approved supplements and 0 published complete response letters.

First approved: Aug 16, 1982
Supplements approved: 4
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 5 submissions below

Date	Submission	Status	Documents
Aug 16, 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 5 submissions, including labeling and manufacturing supplements


Mar 18, 1996	Supplement 10Labeling	Approved	None posted
Feb 10, 1995	Supplement 9Labeling	Approved	None posted
Jun 7, 1994	Supplement 8Labeling	Approved	None posted
Dec 27, 1991	Supplement 7Labeling	Approved	None posted
Aug 16, 1982	Original application	Approved	None posted

Identifiers

Application: ANDA 87767
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