Hydroxyzine Hydrochloride

ANDA 87603, held by Strides Pharma Intl. Hydroxyzine Hydrochloride.

As of Nov 15, 2026, ANDA 87603 (Hydroxyzine Hydrochloride), held by Strides Pharma Intl, was first approved by FDA on Jan 22, 1982, with 14 approved supplements and 0 published complete response letters.

First approved: Jan 22, 1982
Supplements approved: 14
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 15 submissions below

Date	Submission	Status	Documents
Jan 22, 1982	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Hydroxyzine Hydrochloride25MG · tablet;oral	Hydroxyzine Hydrochloride	Discontinued

All 15 submissions, including labeling and manufacturing supplements


Nov 8, 2016	Supplement 31Labeling · Standard review	Approved	None posted
Mar 30, 2016	Supplement 30Labeling · Standard review	Approved	None posted
Jun 3, 2014	Supplement 28Labeling · Standard review	Approved	None posted
Feb 28, 2013	Supplement 27Labeling · Standard review	Approved	None posted
Aug 6, 1989	Supplement 25Labeling	Approved	None posted
Jun 20, 1989	Supplement 24Labeling	Approved	None posted
Oct 15, 1987	Supplement 22Manufacturing	Approved	None posted
Oct 15, 1987	Supplement 21Manufacturing	Approved	None posted
Oct 15, 1987	Supplement 20Manufacturing	Approved	None posted
Nov 8, 1983	Supplement 13Manufacturing	Approved	None posted
Nov 8, 1983	Supplement 12Manufacturing	Approved	None posted
Nov 8, 1983	Supplement 10Manufacturing	Approved	None posted
Nov 8, 1983	Supplement 9Manufacturing	Approved	None posted
Dec 10, 1982	Supplement 8Manufacturing	Approved	None posted
Jan 22, 1982	Original application	Approved	None posted

Identifiers

Application: ANDA 87603
Drugs@FDA: Overview at FDA
Company: Strides Pharma International

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