Relieves anxiety and tension associated with psychoneurosis. ANDA 201674, held by Lannett Co Inc. Hydroxyzine Hydrochloride.
As of Nov 15, 2026, ANDA 201674 (Hydroxyzine Hydrochloride), held by Lannett Co Inc, was first approved by FDA on Aug 21, 2013, 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 in premedication and following general anesthesia, Hydroxyzine may potentiate meperidine (Demerol ) 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 21, 2013 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Hydroxyzine Hydrochloride10MG/5ML · syrup;oral | Hydroxyzine Hydrochloride | Rx |
| Nov 8, 2016 | Supplement 4Labeling · Standard review | Approved | None posted |
| Mar 30, 2016 | Supplement 3Labeling · Standard review | Approved | None posted |
| Jun 18, 2014 | Supplement 2Labeling · Standard review | Approved | None posted |
| Aug 21, 2013 | 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
