ANDA 88594, held by Duramed Pharms Barr. Hydroxyzine Pamoate.
As of Nov 15, 2026, ANDA 88594 (Hydroxyzine Pamoate), held by Duramed Pharms Barr, was not approved, with 4 approved supplements and 0 published complete response letters.
| Product | Active ingredient | Marketing |
|---|---|---|
| Hydroxyzine PamoateEQ 50MG HYDROCHLORIDE ยท capsule;oral | Hydroxyzine Pamoate | Discontinued |
| Nov 9, 1989 | Supplement 19Labeling | Approved | None posted |
| Apr 14, 1989 | Supplement 14Labeling | Approved | None posted |
| Mar 27, 1989 | Supplement 13Labeling | Approved | None posted |
| Sep 2, 1988 | Supplement 11Labeling | 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
