Hydroxyzine Hydrochloride

ANDA 86836, held by Watson Labs. Hydroxyzine Hydrochloride.

As of Nov 15, 2026, ANDA 86836 (Hydroxyzine Hydrochloride), held by Watson Labs, was first approved by FDA on May 15, 1981, with 1 approved supplement and 0 published complete response letters.

First approved: May 15, 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
May 15, 1981	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Hydroxyzine Hydrochloride50MG · tablet;oral	Hydroxyzine Hydrochloride	Discontinued

All 2 submissions, including labeling and manufacturing supplements


Dec 12, 1991	Supplement 26Labeling	Approved	None posted
May 15, 1981	Original application	Approved	None posted

Identifiers

Application: ANDA 86836
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