Hydroxyzine Hydrochloride

ANDA 40010, held by Hikma. Hydroxyzine Hydrochloride.

As of Nov 15, 2026, ANDA 40010 (Hydroxyzine Hydrochloride), held by Hikma, was first approved by FDA on Oct 28, 1994, with 5 approved supplements and 0 published complete response letters.

First approved: Oct 28, 1994
Supplements approved: 5
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 6 submissions below

Date	Submission	Status	Documents
Oct 28, 1994	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Hydroxyzine Hydrochloride10MG/5ML · syrup;oral	Hydroxyzine Hydrochloride	Discontinued

All 6 submissions, including labeling and manufacturing supplements


Nov 8, 2016	Supplement 12Labeling · Standard review	Approved	None posted
Mar 30, 2016	Supplement 11Labeling · Standard review	Approved	None posted
Jun 3, 2014	Supplement 8Labeling · Standard review	Approved	Label Letter
Aug 1, 2000	Supplement 2Manufacturing	Approved	None posted
Aug 1, 2000	Supplement 3Labeling	Approved	None posted
Oct 28, 1994	Original application	Approved	None posted

Identifiers

Application: ANDA 40010
Drugs@FDA: Overview at FDA
Company: Hikma

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