Manages anxiety, tension, and psychomotor agitation in conditions of emotional stress…. ANDA 87408, held by Am Regent. Hydroxyzine Hydrochloride.
As of Nov 15, 2026, ANDA 87408 (Hydroxyzine Hydrochloride), held by Am Regent, was first approved by FDA on Aug 27, 1981, with 12 approved supplements and 0 published complete response letters.
The total management of anxiety, tension, and psychomotor agitation in conditions of emotional stress requires in most instances a combined approach of psychotherapy and chemotherapy. Hydroxyzine has been found to be particularly useful for this latter phase of therapy in its ability to render the disturbed patient more amenable to psychotherapy in long term treatment of the psychoneurotic and psychotic, although it should not be used as the sole treatment of psychosis or of clearly demonstrated cases of depression. Hydroxyzine is also useful in alleviating the manifestations of anxiety and tension as in the preparation for dental procedures and in acute emotional problems.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Aug 27, 1981 | Original application | Approved | None posted |
| Hydroxyzine Hydrochloride25MG/ML · injectable;injection | Hydroxyzine Hydrochloride | RxReference drug |
| Hydroxyzine Hydrochloride50MG/ML · injectable;injection | Hydroxyzine Hydrochloride | RxReference drug |
| Nov 8, 2016 | Supplement 26Labeling · Standard review | Approved | None posted |
| Mar 30, 2016 | Supplement 25Labeling · Standard review | Approved | None posted |
| Jun 3, 2014 | Supplement 22Labeling · Standard review | Approved | None posted |
| Jan 2, 2003 | Supplement 15Labeling | Approved | None posted |
| Jul 17, 2002 | Supplement 14Manufacturing | Approved | None posted |
| Sep 25, 1997 | Supplement 13Manufacturing | Approved | None posted |
| Feb 28, 1996 | Supplement 12Manufacturing | Approved | None posted |
| Dec 24, 1992 | Supplement 11Labeling | Approved | None posted |
| Apr 2, 1992 | Supplement 10Labeling | Approved | None posted |
| Sep 13, 1991 | Supplement 7Manufacturing | Approved | None posted |
| Sep 4, 1991 | Supplement 9Labeling | Approved | None posted |
| May 22, 1991 | Supplement 8Manufacturing | Approved | None posted |
| Aug 27, 1981 | Original application | Approved | None posted |
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
