ANDA 87274, held by Watson Labs. Hydroxyzine Hydrochloride.
As of Nov 15, 2026, ANDA 87274 (Hydroxyzine Hydrochloride), held by Watson Labs, was first approved by FDA on Jul 28, 1981, with 0 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jul 28, 1981 | Original application | Approved | None posted |
| 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
