Relieves anxiety and tension associated with psychoneurosis. ANDA 40808, held by Amneal Pharm. Hydroxyzine Hydrochloride.
As of Nov 15, 2026, ANDA 40808 (Hydroxyzine Hydrochloride), held by Amneal Pharm, was first approved by FDA on Sep 24, 2008, with 3 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 |
|---|---|---|---|
| Sep 24, 2008 | Original application | Approved | None posted |
| Hydroxyzine Hydrochloride10MG · tablet;oral | Hydroxyzine Hydrochloride | Discontinued |
| Hydroxyzine Hydrochloride25MG · tablet;oral | Hydroxyzine Hydrochloride | Discontinued |
| Hydroxyzine Hydrochloride50MG · tablet;oral | Hydroxyzine Hydrochloride | Discontinued |
| Nov 8, 2016 | Supplement 7Labeling · Standard review | Approved | None posted |
| Mar 30, 2016 | Supplement 5Labeling · Standard review | Approved | None posted |
| Jun 4, 2014 | Supplement 4Labeling · Standard review | Approved | None posted |
| Sep 24, 2008 | 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
