Hydroxyzine Hydrochloride

ANDA 87821, held by Kv Pharm. Hydroxyzine Hydrochloride.

As of Nov 15, 2026, ANDA 87821 (Hydroxyzine Hydrochloride), held by Kv Pharm, was first approved by FDA on Jun 23, 1982, with 3 approved supplements and 0 published complete response letters.

First approved: Jun 23, 1982
Supplements approved: 3
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 4 submissions below

Date	Submission	Status	Documents
Jun 23, 1982	Original application	Approved	None posted

Products

1 strengths and forms

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

All 4 submissions, including labeling and manufacturing supplements


Jul 11, 1989	Supplement 12Labeling	Approved	None posted
Sep 2, 1988	Supplement 11Labeling	Approved	None posted
Apr 5, 1988	Supplement 10Labeling	Approved	None posted
Jun 23, 1982	Original application	Approved	None posted

Identifiers

Application: ANDA 87821
Drugs@FDA: Overview at FDA
Company: KV Pharmaceutical

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