Relieves anxiety and tension associated with psychoneurosis. ANDA 217652, held by Graviti Pharms. Hydroxyzine Hydrochloride.
As of Nov 15, 2026, ANDA 217652 (Hydroxyzine Hydrochloride), held by Graviti Pharms, was first approved by FDA on Aug 17, 2023, with 1 approved supplement 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 |
|---|---|---|---|
| Aug 17, 2023 | Original application | Approved | None posted |
| Hydroxyzine Hydrochloride10MG · tablet;oral | Hydroxyzine Hydrochloride | Rx |
| Hydroxyzine Hydrochloride25MG · tablet;oral | Hydroxyzine Hydrochloride | Rx |
| Hydroxyzine Hydrochloride50MG · tablet;oral | Hydroxyzine Hydrochloride | Rx |
| Apr 22, 2025 | Supplement 3Labeling · Standard review | Approved | None posted |
| Aug 17, 2023 | 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
