Relieves anxiety and tension associated with psychoneurosis. ANDA 201507, held by Heritage Pharma. Hydroxyzine Pamoate.
As of Nov 15, 2026, ANDA 201507 (Hydroxyzine Pamoate), held by Heritage Pharma, was first approved by FDA on Jun 3, 2013, with 2 approved supplements and 0 published complete response letters.
INDICATIONS 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 (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 |
|---|---|---|---|
| Jun 3, 2013 | Original application | Approved | None posted |
| Hydroxyzine PamoateEQ 25MG HYDROCHLORIDE · capsule;oral | Hydroxyzine Pamoate | Rx |
| Hydroxyzine PamoateEQ 50MG HYDROCHLORIDE · capsule;oral | Hydroxyzine Pamoate | Rx |
| Jan 24, 2015 | Supplement 3Labeling · Standard review | Approved | None posted |
| Jul 11, 2013 | Supplement 1Manufacturing | Approved | None posted |
| Jun 3, 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
