Hydroxyzine Pamoate

ANDA 89031, held by Superpharm. Hydroxyzine Pamoate.

As of Nov 15, 2026, ANDA 89031 (Hydroxyzine Pamoate), held by Superpharm, was first approved by FDA on Jan 2, 1987, with 2 approved supplements and 0 published complete response letters.

First approved: Jan 2, 1987
Supplements approved: 2
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 3 submissions below

Date	Submission	Status	Documents
Jan 2, 1987	Original application	Approved	None posted

Products

1 strengths and forms

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

All 3 submissions, including labeling and manufacturing supplements


Oct 6, 1989	Supplement 7Labeling	Approved	None posted
Mar 16, 1989	Supplement 6Labeling	Approved	None posted
Jan 2, 1987	Original application	Approved	None posted

Identifiers

Application: ANDA 89031
Drugs@FDA: Overview at FDA
Company: Superpharm

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