Hydroxyzine Hydrochloride

ANDA 85779, held by Dr Reddys. Hydroxyzine Hydrochloride.

As of Nov 15, 2026, ANDA 85779 (Hydroxyzine Hydrochloride), held by Dr Reddys, was first approved by FDA on Oct 5, 1979, with 18 approved supplements and 0 published complete response letters.

First approved: Oct 5, 1979
Supplements approved: 18
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 19 submissions below

Date	Submission	Status	Documents
Oct 5, 1979	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Hydroxyzine Hydrochloride50MG/ML · injectable;injection	Hydroxyzine Hydrochloride	Discontinued

All 19 submissions, including labeling and manufacturing supplements


Nov 8, 2016	Supplement 96Labeling · Standard review	Approved	None posted
Mar 30, 2016	Supplement 95Labeling · Standard review	Approved	None posted
Jun 3, 2014	Supplement 94Labeling · Standard review	Approved	None posted
Feb 19, 1999	Supplement 92Manufacturing	Approved	None posted
Feb 2, 1999	Supplement 91Manufacturing	Approved	None posted
Dec 4, 1996	Supplement 90Manufacturing	Approved	None posted
May 23, 1991	Supplement 89Labeling	Approved	None posted
Feb 11, 1991	Supplement 88Labeling	Approved	None posted
Nov 21, 1990	Supplement 87Manufacturing	Approved	None posted
Dec 4, 1989	Supplement 86Labeling	Approved	None posted
Dec 4, 1989	Supplement 85Labeling	Approved	None posted
Aug 3, 1989	Supplement 84Labeling	Approved	None posted
Sep 21, 1988	Supplement 82Bioequivalence	Approved	None posted
Aug 3, 1988	Supplement 81Manufacturing	Approved	None posted
Aug 3, 1988	Supplement 80Manufacturing	Approved	None posted
May 28, 1986	Supplement 76Manufacturing	Approved	None posted
Dec 30, 1983	Supplement 75Manufacturing	Approved	None posted
Feb 8, 1982	Supplement 73Manufacturing	Approved	None posted
Oct 5, 1979	Original application	Approved	None posted

Identifiers

Application: ANDA 85779
Drugs@FDA: Overview at FDA
Company: Dr. Reddy's Laboratories

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