Hydroxyzine Hydrochloride

ANDA 40580, held by Prinston. Hydroxyzine Hydrochloride.

As of Nov 15, 2026, ANDA 40580 (Hydroxyzine Hydrochloride), held by Prinston, was first approved by FDA on May 27, 2005, with 5 approved supplements and 0 published complete response letters.

First approved: May 27, 2005
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
May 27, 2005	Original application	Approved	None posted

Products

3 strengths and forms


Hydroxyzine Hydrochloride50MG · tablet;oral	Hydroxyzine Hydrochloride	Rx
Hydroxyzine Hydrochloride25MG · tablet;oral	Hydroxyzine Hydrochloride	Rx
Hydroxyzine Hydrochloride10MG · tablet;oral	Hydroxyzine Hydrochloride	Rx

All 6 submissions, including labeling and manufacturing supplements


Nov 8, 2016	Supplement 14Labeling · Standard review	Approved	None posted
Mar 30, 2016	Supplement 11Labeling · Standard review	Approved	None posted
Jun 4, 2014	Supplement 8Labeling · Standard review	Approved	None posted
Apr 30, 2013	Supplement 5Labeling · Standard review	Approved	None posted
Mar 22, 2007	Supplement 1Labeling	Approved	None posted
May 27, 2005	Original application	Approved	None posted

Identifiers

Application: ANDA 40580
Drugs@FDA: Overview at FDA
Company: Prinston 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