Relieves anxiety and tension associated with psychoneurosis. ANDA 87871, held by Aurobindo Pharma Ltd. Hydroxyzine Hydrochloride.
As of Nov 15, 2026, ANDA 87871 (Hydroxyzine Hydrochloride), held by Aurobindo Pharma Ltd, was first approved by FDA on Dec 20, 1982, with 13 approved supplements and 0 published complete response letters.
INDICATIONS AND USAGE For symptomatic relief of anxiety and tension associated with psychoneurosis and as an adjunct in organic disease states in which anxiety is manifested. Useful in the management of pruritus due to allergic conditions such as chronic urticaria and atopic and contact dermatoses and in histamine-mediated pruritus. As a sedative when used as a premedication and following general anesthesia, hydroxyzine may potentiate meperidine and barbiturates, so their use in pre-anesthetic adjunctive therapy should be modified on an individual basis. Atropine and other belladonna alkaloids are not affected by the drug.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Dec 20, 1982 | Original application | Approved | None posted |
| Hydroxyzine Hydrochloride50MG · tablet;oral | Hydroxyzine Hydrochloride | Rx |
| Hydroxyzine Hydrochloride10MG · tablet;oral | Hydroxyzine Hydrochloride | Rx |
| Hydroxyzine Hydrochloride25MG · tablet;oral | Hydroxyzine Hydrochloride | Rx |
| Nov 8, 2016 | Supplement 28Labeling · Standard review | Approved | None posted |
| Mar 30, 2016 | Supplement 27Labeling · Standard review | Approved | None posted |
| Jun 3, 2014 | Supplement 26Labeling · Standard review | Approved | None posted |
| Jan 10, 2000 | Supplement 22Manufacturing | Approved | None posted |
| Feb 21, 1995 | Supplement 21Manufacturing | Approved | None posted |
| Nov 14, 1988 | Supplement 20Labeling | Approved | None posted |
| Apr 25, 1988 | Supplement 14Manufacturing | Approved | None posted |
| Apr 25, 1988 | Supplement 15Manufacturing | Approved | None posted |
| Jul 8, 1985 | Supplement 5Manufacturing | Approved | None posted |
| Jul 8, 1985 | Supplement 8Manufacturing | Approved | None posted |
| Aug 21, 1984 | Supplement 1Manufacturing | Approved | None posted |
| Aug 21, 1984 | Supplement 2Manufacturing | Approved | None posted |
| Aug 21, 1984 | Supplement 4Manufacturing | Approved | None posted |
| Dec 20, 1982 | 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
