ANDA 40563, held by Able. Hydroxyzine Hydrochloride.
As of Nov 15, 2026, ANDA 40563 (Hydroxyzine Hydrochloride), held by Able, was first approved by FDA on Jul 22, 2004, with 0 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jul 22, 2004 | Original application | Approved | None posted |
| 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
