Hydroxyzine Hydrochloride

ANDA 87862, held by Sun Pharm Industries. Hydroxyzine Hydrochloride.

As of Nov 15, 2026, ANDA 87862 (Hydroxyzine Hydrochloride), held by Sun Pharm Industries, was first approved by FDA on Apr 18, 1983, with 11 approved supplements and 0 published complete response letters.

First approved: Apr 18, 1983
Supplements approved: 11
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 12 submissions below

Date	Submission	Status	Documents
Apr 18, 1983	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Hydroxyzine Hydrochloride100MG · tablet;oral	Hydroxyzine Hydrochloride	Discontinued

All 12 submissions, including labeling and manufacturing supplements


Nov 8, 2016	Supplement 17Labeling · Standard review	Approved	None posted
Mar 30, 2016	Supplement 16Labeling · Standard review	Approved	None posted
Jun 3, 2014	Supplement 15Labeling · Standard review	Approved	None posted
Dec 1, 1998	Supplement 14Manufacturing	Approved	None posted
Dec 23, 1994	Supplement 13Manufacturing	Approved	None posted
Oct 11, 1994	Supplement 12Manufacturing	Approved	None posted
Apr 3, 1992	Supplement 11Manufacturing	Approved	None posted
Apr 3, 1992	Supplement 9Manufacturing	Approved	None posted
Dec 8, 1987	Supplement 6Manufacturing	Approved	None posted
Apr 1, 1987	Supplement 4Manufacturing	Approved	None posted
Nov 20, 1984	Supplement 2Manufacturing	Approved	None posted
Apr 18, 1983	Original application	Approved	None posted

Identifiers

Application: ANDA 87862
Drugs@FDA: Overview at FDA
Company: Sun Pharmaceutical Industries

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