Relieves anxiety and tension associated with psychoneurosis. ANDA 88487, held by Barr Labs. Hydroxyzine Pamoate.
As of Nov 15, 2026, ANDA 88487 (Hydroxyzine Pamoate), held by Barr Labs, was first approved by FDA on Jun 15, 1984, with 31 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 50MG HYDROCHLORIDE · capsule;oral | Hydroxyzine Pamoate | Rx |
| Feb 16, 2021 | Supplement 54Labeling · Standard review | Approved | None posted |
| Feb 16, 2021 | Supplement 53Labeling · Standard review | Approved | None posted |
| Jan 24, 2015 | Supplement 50Labeling · Standard review | Approved | None posted |
| Oct 9, 2007 | Supplement 46Labeling | Approved | None posted |
| Jan 3, 2003 | Supplement 32Manufacturing | Approved | None posted |
| Apr 29, 2002 | Supplement 31Manufacturing | Approved | None posted |
| Nov 9, 2001 | Supplement 30Labeling | Approved | None posted |
| Nov 9, 2001 | Supplement 29Labeling | Approved | None posted |
| Feb 29, 2000 | Supplement 28Manufacturing | Approved | None posted |
| Dec 30, 1999 | Supplement 26Manufacturing | Approved | None posted |
| Dec 21, 1999 | Supplement 27Manufacturing | Approved | None posted |
| May 20, 1999 | Supplement 25Manufacturing | Approved | None posted |
| Dec 1, 1998 | Supplement 24Manufacturing | Approved | None posted |
| Sep 18, 1998 | Supplement 23Manufacturing | Approved | None posted |
| Jul 9, 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 |
| 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 |
| Aug 16, 1991 | Supplement 13Manufacturing | Approved | None posted |
| Aug 16, 1991 | Supplement 12Manufacturing | Approved | None posted |
| May 9, 1991 | Supplement 11Labeling | Approved | None posted |
| Jan 4, 1990 | Supplement 60Labeling | Approved | None posted |
| Jan 4, 1990 | Supplement 10Labeling | Approved | None posted |
| Nov 16, 1987 | Supplement 9Manufacturing | Approved | None posted |
| Nov 16, 1987 | Supplement 8Manufacturing | Approved | None posted |
| Mar 31, 1987 | Supplement 7Manufacturing | 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
