Relieves anxiety and tension associated with psychoneurosis. ANDA 40391, held by Pai Holdings Pharm. Hydroxyzine Hydrochloride.
As of Nov 15, 2026, ANDA 40391 (Hydroxyzine Hydrochloride), held by Pai Holdings Pharm, was first approved by FDA on Apr 10, 2002, with 4 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 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 |
|---|---|---|---|
| Apr 10, 2002 | Original application | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Hydroxyzine Hydrochloride10MG/5ML · syrup;oral | Hydroxyzine Hydrochloride | Rx |
| Sep 26, 2024 | Supplement 11Manufacturing | Approved | None posted |
| Nov 8, 2016 | Supplement 9Labeling · Standard review | Approved | None posted |
| Mar 30, 2016 | Supplement 8Labeling · Standard review | Approved | None posted |
| Jun 3, 2014 | Supplement 7Labeling · Standard review | Approved | |
| Apr 10, 2002 | Original application | Approved |
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
