Relieves anxiety and tension associated with psychoneurosis. ANDA 88488, held by Barr Labs. Hydroxyzine Pamoate.
As of Nov 15, 2026, ANDA 88488 (Hydroxyzine Pamoate), held by Barr Labs, was first approved by FDA on Jun 15, 1984, with 32 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 (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 15, 1984 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Hydroxyzine PamoateEQ 100MG HYDROCHLORIDE · capsule;oral | Hydroxyzine Pamoate | Rx |
| Feb 16, 2021 | Supplement 52Labeling · Standard review | Approved | None posted |
| Feb 16, 2021 | Supplement 51Labeling · Standard review | Approved | None posted |
| Jan 24, 2015 | Supplement 48Labeling · Standard review | Approved | None posted |
| Jul 27, 2011 | Supplement 44Manufacturing | Approved | None posted |
| May 28, 2008 | Supplement 43Labeling | Approved | None posted |
| Jan 3, 2003 | Supplement 33Manufacturing | Approved | None posted |
| Apr 29, 2002 | Supplement 32Manufacturing | Approved | None posted |
| Nov 9, 2001 | Supplement 31Labeling | Approved | None posted |
| Nov 9, 2001 | Supplement 30Labeling | Approved | None posted |
| Feb 3, 2000 | Supplement 29Manufacturing | Approved | None posted |
| Dec 21, 1999 | Supplement 28Manufacturing | Approved | None posted |
| Jun 11, 1999 | Supplement 27Manufacturing | Approved | None posted |
| May 20, 1999 | Supplement 26Manufacturing | Approved | None posted |
| Dec 1, 1998 | Supplement 24Manufacturing | Approved | None posted |
| Nov 16, 1998 | Supplement 25Manufacturing | Approved | None posted |
| Nov 16, 1998 | Supplement 23Manufacturing | Approved | None posted |
| Nov 16, 1998 | Supplement 22Manufacturing | Approved | None posted |
| Sep 20, 1996 | Supplement 21Labeling | Approved | None posted |
| Apr 10, 1996 | Supplement 20Labeling | Approved | None posted |
| Jan 12, 1995 | Supplement 14Labeling | Approved | None posted |
| Jan 12, 1995 | Supplement 13Manufacturing | Approved | None posted |
| Dec 23, 1994 | Supplement 19Manufacturing | Approved | None posted |
| Oct 11, 1994 | Supplement 18Manufacturing | Approved | None posted |
| Apr 3, 1992 | Supplement 17Manufacturing | Approved | None posted |
| Apr 3, 1992 | Supplement 15Manufacturing | Approved | None posted |
| May 9, 1991 | Supplement 12Labeling | Approved | None posted |
| Jan 4, 1990 | Supplement 11Labeling | Approved | None posted |
| Sep 12, 1989 | Supplement 10Labeling | Approved | None posted |
| Nov 18, 1987 | Supplement 8Manufacturing | Approved | None posted |
| Nov 18, 1987 | Supplement 7Manufacturing | Approved | None posted |
| Mar 31, 1987 | Supplement 6Manufacturing | Approved | None posted |
| Sep 25, 1984 | Supplement 2Manufacturing | Approved | None posted |
| Jun 15, 1984 | 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
