ANDA 89396, held by Halsey. Hydroxyzine Hydrochloride.
As of Nov 15, 2026, ANDA 89396 (Hydroxyzine Hydrochloride), held by Halsey, was not approved, with 0 approved supplements and 0 published complete response letters.
| Product | Active ingredient | Marketing |
|---|---|---|
| Hydroxyzine Hydrochloride50MG ยท tablet;oral | Hydroxyzine Hydrochloride | 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
