Hydroxyzine Hydrochloride

ANDA 86880, held by Rising. Hydroxyzine Hydrochloride.

As of Nov 15, 2026, ANDA 86880 (Hydroxyzine Hydrochloride), held by Rising, was first approved by FDA on Jul 17, 1980, with 23 approved supplements and 0 published complete response letters.

First approved: Jul 17, 1980
Supplements approved: 23
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 24 submissions below

Date	Submission	Status	Documents
Jul 17, 1980	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Hydroxyzine Hydrochloride10MG/5ML · syrup;oral	Hydroxyzine Hydrochloride	Discontinued

All 24 submissions, including labeling and manufacturing supplements


Nov 8, 2016	Supplement 41Labeling · Standard review	Approved	None posted
Mar 30, 2016	Supplement 40Labeling · Standard review	Approved	None posted
Jun 3, 2014	Supplement 38Labeling · Standard review	Approved	None posted
Apr 24, 2003	Supplement 33Labeling	Approved	None posted
Mar 15, 2000	Supplement 32Manufacturing	Approved	None posted
Mar 15, 2000	Supplement 31Manufacturing	Approved	None posted
Mar 15, 2000	Supplement 30Manufacturing	Approved	None posted
Mar 15, 2000	Supplement 29Manufacturing	Approved	None posted
Jul 17, 1998	Supplement 28Manufacturing	Approved	None posted
Jun 12, 1995	Supplement 26Manufacturing	Approved	None posted
Aug 17, 1992	Supplement 23Manufacturing	Approved	None posted
Jun 11, 1991	Supplement 25Manufacturing	Approved	None posted
Sep 28, 1990	Supplement 24Manufacturing	Approved	None posted
May 9, 1990	Supplement 22Labeling	Approved	None posted
May 31, 1989	Supplement 21Manufacturing	Approved	None posted
May 31, 1989	Supplement 20Manufacturing	Approved	None posted
May 31, 1989	Supplement 19Manufacturing	Approved	None posted
Feb 24, 1987	Supplement 18Manufacturing	Approved	None posted
Feb 24, 1987	Supplement 17Manufacturing	Approved	None posted
May 9, 1986	Supplement 16Manufacturing	Approved	None posted
Oct 2, 1985	Supplement 15Manufacturing	Approved	None posted
Feb 10, 1983	Supplement 13Manufacturing	Approved	None posted
Mar 30, 1982	Supplement 8Manufacturing	Approved	None posted
Jul 17, 1980	Original application	Approved	None posted

Identifiers

Application: ANDA 86880
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