Atarax

NDA 10392, held by Pfizer. Hydroxyzine Hydrochloride.

As of Nov 13, 2026, NDA 10392 (Atarax), held by Pfizer, was first approved by FDA on Apr 12, 1956, with 8 approved supplements and 0 published complete response letters.

First approved: Apr 12, 1956
Review: Standard
Supplements approved: 8
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 9 submissions below

Date	Submission	Status	Documents
Apr 12, 1956	Original applicationNew molecular entity · Standard review	Approved	None posted

Products

4 strengths and forms


Atarax10MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · tablet;oral	Hydroxyzine Hydrochloride	DiscontinuedReference drug
Atarax25MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · tablet;oral	Hydroxyzine Hydrochloride	DiscontinuedReference drug
Atarax100MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · tablet;oral	Hydroxyzine Hydrochloride	DiscontinuedReference drug
Atarax50MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · tablet;oral	Hydroxyzine Hydrochloride	DiscontinuedReference drug

All 9 submissions, including labeling and manufacturing supplements


Mar 21, 2001	Supplement 41Labeling · Standard review	Approved	Letter
Mar 27, 2000	Supplement 40Manufacturing · Standard review	Approved	None posted
Jan 16, 1998	Supplement 38Manufacturing · Standard review	Approved	None posted
Jan 16, 1998	Supplement 36Manufacturing · Standard review	Approved	None posted
Jul 12, 1994	Supplement 37Manufacturing · Standard review	Approved	None posted
May 20, 1985	Supplement 31Labeling	Approved	None posted
May 21, 1979	Supplement 21Labeling	Approved	None posted
Dec 2, 1974	Supplement 8Labeling	Approved	None posted
Apr 12, 1956	Original applicationNew molecular entity · Standard review	Approved	None posted

Identifiers

Application: NDA 10392
Drugs@FDA: Overview at FDA
Company: Pfizer

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