Hydroxyzine Hydrochloride

ANDA 40812, held by Somerset Theraps LLC. Hydroxyzine Hydrochloride.

As of Nov 15, 2026, ANDA 40812 (Hydroxyzine Hydrochloride), held by Somerset Theraps LLC, was first approved by FDA on Mar 12, 2008, with 3 approved supplements and 0 published complete response letters.

First approved: Mar 12, 2008
Supplements approved: 3
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 4 submissions below

Date	Submission	Status	Documents
Mar 12, 2008	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 4 submissions, including labeling and manufacturing supplements


Nov 8, 2016	Supplement 7Labeling · Standard review	Approved	None posted
Mar 30, 2016	Supplement 5Labeling · Standard review	Approved	None posted
Jun 3, 2014	Supplement 3Labeling · Standard review	Approved	None posted
Mar 12, 2008	Original application	Approved	None posted

Identifiers

Application: ANDA 40812
Drugs@FDA: Overview at FDA
Company: Somerset Therapeutics

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