ANDA 86258, held by Wyeth Ayerst. Hydroxyzine Hydrochloride.
As of Nov 15, 2026, ANDA 86258 (Hydroxyzine Hydrochloride), held by Wyeth Ayerst, was not approved, with 0 approved supplements and 0 published complete response letters.
| Hydroxyzine Hydrochloride25MG/ML · injectable;injection | Hydroxyzine Hydrochloride | Discontinued |
| Hydroxyzine Hydrochloride50MG/ML · injectable;injection | 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
