ANDA 87216, held by Ivax Pharms. Hydroxyzine Hydrochloride.
As of Nov 15, 2026, ANDA 87216 (Hydroxyzine Hydrochloride), held by Ivax Pharms, was first approved by FDA on Apr 3, 1981, with 0 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Apr 3, 1981 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Hydroxyzine Hydrochloride10MG 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
