Hydroxyzine Hydrochloride

ANDA 40841, held by Northstar Hlthcare. Hydroxyzine Hydrochloride.

As of Nov 15, 2026, ANDA 40841 (Hydroxyzine Hydrochloride), held by Northstar Hlthcare, was first approved by FDA on Mar 31, 2008, with 4 approved supplements and 0 published complete response letters.

First approved: Mar 31, 2008
Supplements approved: 4
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 5 submissions below

Date	Submission	Status	Documents
Mar 31, 2008	Original application	Approved	None posted

Products

1 strengths and forms

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

All 5 submissions, including labeling and manufacturing supplements


Jun 3, 2014	Supplement 6Labeling · Standard review	Approved	None posted
Apr 30, 2014	Supplement 5Labeling · Standard review	Approved	None posted
Jan 17, 2013	Supplement 4Labeling · Standard review	Approved	None posted
Dec 8, 2011	Supplement 2Labeling	Approved	None posted
Mar 31, 2008	Original application	Approved	None posted

Identifiers

Application: ANDA 40841
Drugs@FDA: Overview at FDA
Company: Northstar Healthcare

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