ANDA 88713, held by Teva. Hydroxyzine Pamoate.
As of Nov 15, 2026, ANDA 88713 (Hy-Pam "25"), held by Teva, was first approved by FDA on Mar 4, 1985, with 0 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Mar 4, 1985 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Hy-Pam "25"EQ 25MG HYDROCHLORIDE ยท capsule;oral | Hydroxyzine Pamoate | 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
