Hydroxyzine Hydrochloride

ANDA 91176, held by Rising. Hydroxyzine Hydrochloride.

As of Nov 15, 2026, ANDA 91176 (Hydroxyzine Hydrochloride), held by Rising, was first approved by FDA on Jun 7, 2010, with 4 approved supplements and 0 published complete response letters.

First approved: Jun 7, 2010
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
Jun 7, 2010	Original application	Approved	None posted

Products

3 strengths and forms


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

All 5 submissions, including labeling and manufacturing supplements


Nov 8, 2016	Supplement 7Labeling · Standard review	Approved	None posted
Mar 30, 2016	Supplement 6Labeling · Standard review	Approved	None posted
Nov 28, 2014	Supplement 3Labeling · Standard review	Approved	None posted
Jun 4, 2014	Supplement 2Labeling · Standard review	Approved	None posted
Jun 7, 2010	Original application	Approved	None posted

Identifiers

Application: ANDA 91176
Drugs@FDA: Overview at FDA
Company: Rising Pharmaceuticals

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