Vistaril

NDA 11795, held by Pfizer. Hydroxyzine Pamoate.

As of Nov 13, 2026, NDA 11795 (Vistaril), held by Pfizer, was first approved by FDA on Jun 3, 1959, with 10 approved supplements and 0 published complete response letters.

First approved: Jun 3, 1959
Review: Standard
Supplements approved: 10
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 11 submissions below

Date	Submission	Status	Documents
Jun 3, 1959	Original applicationNew dosage form · Standard review	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
VistarilEQ 25MG HYDROCHLORIDE/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · suspension;oral	Hydroxyzine Pamoate	DiscontinuedReference drug

All 11 submissions, including labeling and manufacturing supplements


Nov 8, 2016	Supplement 28Labeling	Approved	Letter Label
Feb 18, 2016	Supplement 27Labeling	Approved	Label Letter
Jun 3, 2014	Supplement 25Labeling · Standard review	Approved	Letter Label
Dec 24, 2004	Supplement 20Labeling · Standard review	Approved	Letter
Mar 21, 2001	Supplement 18Labeling · Standard review	Approved	Letter
Aug 30, 2000	Supplement 16Labeling · Standard review	Approved	None posted
Jul 20, 2000	Supplement 19Manufacturing · Standard review	Approved	None posted
May 21, 1979	Supplement 11Labeling	Approved	None posted
Jun 6, 1975	Supplement 6Manufacturing · Standard review	Approved	None posted
Dec 2, 1974	Supplement 5Labeling	Approved	None posted
Jun 3, 1959	Original applicationNew dosage form · Standard review	Approved	None posted

Identifiers

Application: NDA 11795
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