Hydroxyzine Hydrochloride

ANDA 87857, held by Mutual Pharm. Hydroxyzine Hydrochloride.

As of Nov 15, 2026, ANDA 87857 (Hydroxyzine Hydrochloride), held by Mutual Pharm, was first approved by FDA on Apr 18, 1983, with 9 approved supplements and 0 published complete response letters.

First approved: Apr 18, 1983
Supplements approved: 9
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 10 submissions below

Date	Submission	Status	Documents
Apr 18, 1983	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Hydroxyzine Hydrochloride25MG · tablet;oral	Hydroxyzine Hydrochloride	Discontinued

All 10 submissions, including labeling and manufacturing supplements


Dec 1, 1998	Supplement 14Manufacturing	Approved	None posted
Dec 23, 1994	Supplement 13Manufacturing	Approved	None posted
Oct 11, 1994	Supplement 12Manufacturing	Approved	None posted
Apr 3, 1992	Supplement 9Manufacturing	Approved	None posted
Apr 3, 1992	Supplement 11Manufacturing	Approved	None posted
Dec 10, 1987	Supplement 6Manufacturing	Approved	None posted
Dec 10, 1987	Supplement 7Manufacturing	Approved	None posted
Apr 1, 1987	Supplement 4Manufacturing	Approved	None posted
Nov 20, 1984	Supplement 2Manufacturing	Approved	None posted
Apr 18, 1983	Original application	Approved	None posted

Identifiers

Application: ANDA 87857
Drugs@FDA: Overview at FDA
Company: Mutual Pharmaceutical Company

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