ANDA 86728, held by Watson Labs. Hydroxyzine Pamoate.
As of Nov 15, 2026, ANDA 86728 (Hydroxyzine Pamoate), held by Watson Labs, was first approved by FDA on Oct 5, 1982, with 0 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Oct 5, 1982 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Hydroxyzine PamoateEQ 100MG HYDROCHLORIDE ยท capsule;oral | Hydroxyzine Pamoate | Discontinued |
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
