Hydroxyzine Hydrochloride

ANDA 88409, held by Mutual Pharm. Hydroxyzine Hydrochloride.

As of Nov 15, 2026, ANDA 88409 (Hydroxyzine Hydrochloride), held by Mutual Pharm, was first approved by FDA on Nov 15, 1983, with 9 approved supplements and 0 published complete response letters.

First approved: Nov 15, 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
Nov 15, 1983	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Hydroxyzine Hydrochloride10MG · 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 11Manufacturing	Approved	None posted
Apr 3, 1992	Supplement 9Manufacturing	Approved	None posted
Dec 10, 1987	Supplement 6Manufacturing	Approved	None posted
Mar 25, 1987	Supplement 5Manufacturing	Approved	None posted
Mar 26, 1985	Supplement 3Manufacturing	Approved	None posted
Nov 20, 1984	Supplement 2Manufacturing	Approved	None posted
Nov 15, 1983	Original application	Approved	None posted

Identifiers

Application: ANDA 88409
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