Hydroxyzine Hydrochloride

ANDA 86827, held by Watson Labs. Hydroxyzine Hydrochloride.

As of Nov 15, 2026, ANDA 86827 (Hydroxyzine Hydrochloride), held by Watson Labs, was first approved by FDA on Mar 20, 1981, with 1 approved supplement and 0 published complete response letters.

First approved: Mar 20, 1981
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
Mar 20, 1981	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Hydroxyzine Hydrochloride10MG · tablet;oral	Hydroxyzine Hydrochloride	Discontinued

All 2 submissions, including labeling and manufacturing supplements


Dec 12, 1991	Supplement 21Labeling	Approved	None posted
Mar 20, 1981	Original application	Approved	None posted

Identifiers

Application: ANDA 86827
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